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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

• Study and protocol design
• Study startup
• Site activation
• Recruitment
• Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
• IRB and IEC approval
• Site management
• Investigational product distribution and management of study materials
• Laboratories (analyses, lab tests, imaging, etc.)
• Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

• Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
• Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
• Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
• Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
• Liaising : Acting as a central point of contact for members of the project team and sponsors.
• Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

• Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
• Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
• Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
• Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
• Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
• Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

• Electronic patient-reported outcomes ( ePRO )
• Electronic trial master files ( eTMF )
• Electronic clinical outcome assessments ( eCOA )
• Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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Popular guides.

Project Management In Clinical Trials: A Comprehensive Guide

Project management in clinical trials involves the systematic planning, execution, and oversight of clinical studies to ensure their success. From initial planning stages to final execution and reporting, understanding the complexities and best practices of project management is crucial for achieving reliable and impactful results in clinical research.

As clinical trials are essential for advancing medical science and developing new treatments, they are complex undertakings requiring meticulous management to navigate regulatory requirements, manage resources, and ensure protocol adherence. 

This article explores key aspects of project management in clinical trials, including planning, budgeting, risk management, and compliance, offering valuable insights and strategies for managing these intricate projects effectively.

Key points to consider in project management in clinical trials

Project management in clinical trials is not merely about overseeing daily operations but involves a comprehensive understanding of various aspects that contribute to the trial’s success. 

Effective project management requires balancing multiple elements, including timelines, budgets, team coordination, and regulatory compliance. 

This section delves into the core components of project management in clinical trials, highlighting what professionals need to understand to manage these projects efficiently.

1. Understanding the scope

Clearly defining the scope of the clinical trial, including objectives, endpoints, and methodologies, is crucial. A well-defined scope helps in setting realistic goals and expectations and ensures all stakeholders are aligned.

2. Stakeholder engagement

Engaging with all relevant stakeholders, including sponsors, regulatory bodies, and participants, is essential for smooth trial operations. Effective communication and collaboration can prevent misunderstandings and ensure that everyone is working towards common goals.

3. Resource allocation

Properly allocating resources, including personnel, equipment, and funding, is critical for the success of a clinical trial. Effective resource management helps avoid shortages and ensure that all aspects of the trial are adequately supported.

4. Risk management

Identifying and managing potential risks is a key aspect of project management. This involves anticipating possible issues, developing contingency plans, and implementing strategies to mitigate risks.

5. Compliance and ethics

Adhering to regulatory requirements and ethical standards is fundamental. Compliance ensures the trial meets all legal and ethical obligations, protecting participants and maintaining the credibility of the research.

6. Data management

Effective data management practices ensure the accuracy and security of the data collected during the trial. Proper data handling and analysis are crucial for drawing valid conclusions and making informed decisions.

Regulatory compliances and standards for clinical trial project management 

Compliance with regulations and standards is essential in clinical trials to ensure the safety of participants, the integrity of the data, and the credibility of the research. Adhering to these requirements helps mitigate risks, avoid legal issues, and maintain ethical standards. 

This section outlines the key compliance requirements and regulations involved in project management for clinical trials.

1. Good Clinical Practice (GCP) 

GCP guidelines ensure that clinical trials are conducted ethically and scientifically. They cover the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials.

2. International Conference on Harmonisation (ICH) guidelines  

The ICH guidelines provide a unified standard for clinical trials across different countries, facilitating international collaboration and data sharing. They include requirements for study design, conduct, and reporting.

3. Food and Drug Administration (FDA) regulations

The FDA oversees clinical trials in the United States, enforcing regulations related to trial conduct, drug development, and data integrity. This includes ensuring compliance with the Code of Federal Regulations (CFR) Title 21.

4. European Medicines Agency (EMA) guidelines 

The EMA provides guidelines for clinical trials conducted in the European Union, focusing on trial design, conduct, and the protection of trial participants. These guidelines ensure consistency and regulatory compliance across member states.

5. Health Insurance Portability and Accountability Act (HIPAA) 

In the U.S., HIPAA protects the privacy and security of health information. Clinical trials must comply with HIPAA regulations to ensure the confidentiality and proper handling of patient data.

6. Institutional Review Board (IRB) approval 

An IRB reviews and approves clinical trial protocols to ensure ethical standards and participant safety. Approval is required before a trial can begin and during any significant protocol changes.

7. ClinicalTrials.gov registration

In the U.S., trials must be registered with ClinicalTrials.gov to provide transparency and access to trial information. Registration helps ensure that trial results are publicly available and accessible.

8. Thai Food and Drug Administration (Thai FDA)

The Thai FDA regulates clinical trials in Thailand, ensuring compliance with local regulations and ethical standards. It oversees the approval and monitoring of clinical trials to protect participant safety and data integrity.

9. Therapeutic Goods Administration (TGA) – Australia

The TGA oversees clinical trials in Australia, focusing on drug safety, efficacy, and quality. It ensures trials adhere to Australian regulations and ethical standards, including requirements for informed consent and trial registration.

10. Pharmaceuticals and Medical Devices Agency (PMDA) – Japan

The PMDA regulates clinical trials in Japan, ensuring compliance with Japanese laws and guidelines. It oversees drug development processes, including trial approval and monitoring, to ensure participant safety and data accuracy.

11. National Pharmaceutical Regulatory Agency (NPRA) – Malaysia

The NPRA oversees clinical trials in Malaysia, focusing on drug safety and efficacy. It ensures trials comply with Malaysian regulations, including ethical standards and data integrity requirements.

12. Ministry of Food and Drug Safety (MFDS) – South Korea

The MFDS regulates clinical trials in South Korea, ensuring adherence to local regulations and ethical standards. It oversees the approval process and monitoring of trials to protect participant welfare and ensure data reliability.

Stepwise guide for project management in clinical trials

Successful project management in clinical trials involves a series of structured steps that guide the project from initiation through to completion. Each step plays a vital role in ensuring that the trial is conducted efficiently, within budget, and in compliance with all regulations. 

This section outlines the key steps involved in managing a clinical trial, providing a roadmap for effective project management.

• The initiation phase involves defining the trial’s objectives, scope, and feasibility. 
• This step includes developing the trial protocol, securing necessary approvals, and outlining the project plan. Clear goals and a solid plan set the stage for successful project execution.
• In the planning phase, detailed project plans are created, including timelines, budgets, and resource allocation. 
• This step involves outlining the trial’s processes, identifying potential risks, and developing strategies to address them. 
• A comprehensive plan ensures that all aspects of the trial are well-organized and ready for execution.
• During the execution phase, the trial is implemented according to the project plan. 
• This involves coordinating activities, managing resources, and ensuring that all procedures are followed as outlined. 
• Effective execution requires close monitoring and timely adjustments to address any issues that arise.
• The monitoring phase involves tracking the trial’s progress, evaluating performance, and ensuring adherence to protocols. 
• Regular monitoring helps identify deviations from the plan and implement corrective actions. 
• This step is crucial for maintaining the trial’s integrity and ensuring that objectives are being met.
• The closure phase involves finalizing all trial activities, including data analysis, reporting, and documentation. 
• This step ensures that all deliverables are completed, results are reviewed, and final reports are prepared. 
• Proper closure includes assessing the trial’s outcomes and documenting lessons learned for future reference.

Challenges and how to overcome them in project management in clinical trials

Project management in clinical trials involves navigating a range of challenges that can impact the success of the study. These challenges can arise from various factors, including resource constraints, regulatory complexities, and unexpected issues during execution. Addressing these challenges effectively is crucial for ensuring the smooth operation of the trial and achieving reliable results. This section outlines common challenges faced in project management and provides practical solutions to overcome them.

Budget Overruns

• Develop a detailed budget with contingency funds
• Regularly monitor expenses and adjust allocations as needed
• Conduct periodic financial reviews to identify and address potential overspending early

Resource allocation

• Create a resource plan that outlines required personnel, equipment, and facilities 
• Prioritize tasks and allocate resources based on project needs
• Use resource management tools to track and optimize resource usage

Regulatory compliance

• Stay informed about relevant regulations and guidelines
• Implement a compliance checklist and conduct regular audits to ensure adherence 
• Provide training for staff on regulatory requirements and updates

Risk management

• Identify potential risks during the planning phase and develop mitigation strategies 
• Regularly review and update the risk management plan
• Establish a risk response team to address issues as they arise

Data management

• Use secure and reliable data management systems 
• Implement data quality control measures and ensure proper training for data handlin
• Regularly back up data and conduct audits to verify accuracy

Communication issues

• Establish clear communication channels and protocols 
• Use project management software to facilitate information sharing 
• Hold regular meetings and provide updates to all team members and stakeholders

Delays in project timelines

• Develop a realistic project timeline with built-in buffers
• Monitor progress regularly and identify potential delays early 
• Adjust the schedule as needed and communicate changes promptly to all parties involved

Addressing these challenges with proactive strategies helps ensure the successful management of clinical trials, leading to accurate and impactful results.

Project management in clinical trials is a critical aspect that ensures the successful execution and completion of studies. By understanding and applying best practices in planning, resource management, risk mitigation, and compliance, project managers can enhance the efficiency and effectiveness of clinical trials. 

Proper project management not only contributes to the successful delivery of trial results but also upholds the integrity and credibility of the research. Through meticulous planning and execution, clinical trials can achieve their objectives and contribute significantly to advancements in medical science and patient care.

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Project Management In Clinical Trials: Practical 2024 Guide

If you’re new to project management in clinical trials, this guide will help you understand what it means to be a project manager on a clinical trial, and then provide some practical tips to help you plan and manage your clinical trial effectively.

• Struggling to effectively manage timelines and budgets in clinical trial projects?
• Feeling overwhelmed by the complexity of regulatory requirements and documentation?
• Unsure how to navigate communication challenges between stakeholders?

This article is for:

• Clinical trial project managers seeking practical strategies for streamlining processes and maximizing efficiency.
• Researchers and coordinators looking to enhance their understanding of project management principles in the context of clinical trials.
• Pharmaceutical and biotech professionals interested in improving trial outcomes through effective project management techniques.

Project Management in Clinical Trials: How Does It Work?

As a Project Manager, you may need to be prepared to manage client expectations from day one and will be responsible for managing resources and relationships with internal and external parties. As a Project Manager, your main job function is to get projects completed on time.

The importance of your role means that you will have regular contact with senior stakeholders across all functions in an organization and therefore be highly visible within your organization. You will ensure your team is focused on building long-term relationships that benefit both parties; being able to build good relationships quickly will allow you a high level of engagement with key stakeholders.

Good project management in clinical trials requires a detailed understanding of business procedures, being aware of commercial and strategic priorities, and an awareness of key performance indicators and trends. The key areas of expertise for clinical trial project managers are communication, relationships, influence, planning, attention to detail, and following instructions.

Strong teamwork skills are also essential when working on projects as well as people management skills. You will need to be adaptable to a rapidly changing environment with diverse cultures; you will also be required to negotiate successfully with stakeholders at all levels.

Being an effective project manager in clinical trials is a challenging but fulfilling role. As well as being rewarded with great job satisfaction, you may find your salary increases significantly as you gain experience. However, like any other profession, there are challenges associated with being a clinical trial project manager and you will need to be emotionally resilient when dealing with change.

Common problems include:

• Rapidly changing priorities and unrealistic expectations of resources
• Internal conflict between team members
• Dealing with stressful situations on a daily basis such as late deliveries or looming deadlines
• Having limited influence over projects due to numerous stakeholders who have input on projects being assigned to your team

You will need to be able to organize tasks based on deadlines, manage staff resource allocation, and work with your team members to ensure projects are completed on time. It is essential that you listen to client requirements when managing your project. Your team will look to you for guidance in difficult situations and as such, it is vital that you have excellent communication skills. You will also be required to report project status information throughout a project lifecycle as well as performance against specific objectives, these metrics can be used by management in evaluating staff effectiveness.

Tips for a Clinical Project Manager

Clinical project manager is one of those jobs that, like teaching or parenting, requires a different set of skills and approaches. Among other things, it requires project management.

So what makes managing clinical research projects different from any other sort of project?

Well, in order to begin answering that question let’s first look at what makes any sort of project management different from regular life. In short, it is knowing your resources and being able to apply them towards meeting goals.

Here are some things that a clinical project manager should keep in mind:

• Having a solid budget and a clear schedule for every step of your project.
• Having effective methods for team communication, as well as leadership from above.
• Working with expert subject matter consultants to make sure that your plans are effective and reliable.

There are many other tips for being a good clinical project manager, but these are some of the biggest in terms of avoiding common pitfalls or conflicts in project management methodology. If you want to be successful in your job, know what resources you have access to and how they can be used most effectively.

Don’t forget to consider tips that are specific to project management in clinical trials. These might be more limited, but they can be equally important for your team. For example, working with regulatory bodies is a critical part of any clinical trial, but understanding how to navigate their complex structure and meet their expectations can be a challenge for even experienced project managers.

Good project management for clinical trials is an essential part of a successful research process. Having a clear plan from start to finish, as well as qualified personnel, can help you to avoid common pitfalls and make sure that your project comes in on time and within budget. And there are many more tips and tricks that you can use when you need to work with regulatory bodies or coordinate teams of expert consultants. Remember that just because something seems different doesn’t mean it has to be overwhelming. Use good project management techniques to keep your focus on what matters most: getting results!

How to run effective meetings with your team members

One of the most important aspects of project management for clinical trials are effective meetings. No matter how efficient your team members are, if they’re not meeting regularly, then it’s going to be difficult to keep projects on schedule and ensure that everyone knows what’s going on at all times. Effective meetings help to solve problems quickly, identify potential issues before they become major roadblocks and keep everyone moving forward with their work. The key is to hold effective meetings consistently, meetings are only useful if they’re regularly scheduled and if people feel comfortable discussing what needs to be discussed.

Pick a meeting location and schedule that works for everyone on your team. Meetings are only useful if they’re easy to get to and scheduled at a time when everyone can attend. Try to avoid scheduling too many meetings all at once as it can become overwhelming. Likewise, try not to schedule them at times when people are likely to be focused on work that isn’t directly related. People need time in their day to focus on other tasks and don’t want unrelated matters distracting them from what they need to be doing.

Follow these tips to help keep your meetings effective:

• Make sure that everyone is on time for meetings.
• If someone is late, you might need to reschedule so that they can come and discuss whatever it was.
• Be sure to start and end meetings on time.
• It’s also a good idea to have a meeting go-round. It is a great way to make sure that everyone has had an opportunity to talk about their topics during meetings. How often you do go-rounds depends on how many people are in your meetings. It is best not to waste too much time talking over each other just because there are more people present.

Keeping your team informed about the clinical trial

Keeping a clinical trial team informed on a daily basis is key to success. There’s just too much going on during these types of projects to not communicate regularly with your team members and update them on all their responsibilities and deliverables. A good project manager will be able to keep stakeholders informed with reports and will keep team members informed with notes or individual emails.

As new information comes in, the project manager can quickly and easily relay it to everyone involved in a timely manner. That type of communication helps ensure you aren’t wasting time answering basic questions again and again or waiting for important feedback from someone who isn’t aware of what’s happening.

An example of an effective way to keep stakeholders informed is with regular emails and reports. Project managers who are taking part in a clinical trial should receive updates and relevant information on a daily basis, so they can distribute it to their teams as needed. This keeps everyone informed while reducing back-and-forth communication and helps reduce confusion.

As a clinical project manager, you may also be asked to help keep patients informed about their participation in a trial. This type of communication with patients is generally conducted through phone calls or emails and depends on how long they have been participating in that trial. For more information on your role as a project manager when it comes to patient communication and retention, check out some helpful resources from Clinical Trials Arena .

Project management principles in clinical trials

Just like in any other business, planning and management are key to a successful clinical trial. A good manager should set clear goals, organize resources and delegate tasks so that all team members are clear on their responsibilities. They should also facilitate communication among team members, look for opportunities to make improvements, and be proactive with regards to potential issues.

We know what you’re thinking: your scientific skills have little to do with project management—but there’s truth in that statement only if you think of management as supervising every aspect of your study yourself. Think of it instead as simply facilitating effective teamwork so everyone involved is aware of what their role is and how they can best contribute toward achieving success.

A good project manager will also recognize that there are different types of clinical trials, each with their own set of challenges. For example, a drug study will have its own specific regulatory requirements and an investigation into new medical devices may involve equipment and electronic record keeping.

The clinical trial project manager should discuss these factors at length with their team so that everyone involved knows what to expect and is prepared for any hiccups along the way. This will ultimately lead to a smoother process overall—especially if you’re conducting your research over several years—and allow you to make better use of valuable time and resources.

It is important to always think ahead. It might be tempting to take a day off when you’re tired, but doing so can really set you back in your work. For example, if you’re a clinical project manager and decide not to come into work one day because of fatigue, that could leave your team shorthanded for a couple of days—which may mean that testing has to be postponed for weeks or months. Not only does that mean your research will take longer than anticipated, but also you may find yourself running up against regulatory deadlines later on down the line which are much harder to meet with a short timeframe. The Project Management Institute has a page dedicated to clinical trial information for additional information.

What is a clinical trial project plan?

The specific deliverables and timelines of a project plan are based on what an individual project manager expects to accomplish. A single clinical trial can take years, so having concrete milestones and deliverables with exact timing is essential for project management in clinical trials. Project managers will often develop detailed, line-by-line schedules that map out a year or more of tasks and related deadlines. Major milestones can include everything from identifying sites and recruiting participants to regulatory submission requirements or final approval of study results by ethics committees. Project managers in clinical trials will work closely with other members of research teams—from technicians performing experiments to doctors who conduct examinations—to ensure their efforts remain on track.

Many project managers in clinical trials will also develop detailed budgets for their projects, mapping out how much time and money is being spent on each step of research. Tracking costs from day one can help a project manager avoid major costs down the line. Even simple errors can end up costing hundreds of thousands or even millions of dollars over an extended project timeline.

A detailed budget will help an experienced project manager identify opportunities to save money while still keeping their project on schedule and within its budget, ensuring that study efforts don’t experience any major bottlenecks. As with any other kind of project management work, it is vital to ensure that your clinical trial has assigned resources at every step.

You can also see why project management in clinical trials is needed: multiple research groups, vast amounts of money and costly resources, many moving parts. And because clinical trial projects are often funded by pharmaceutical companies or other entities with a financial stake in study results, having a designated project manager with expertise in study design and patient recruitment will ensure that everyone on your team is working to improve your end product: better drugs for patients. By hiring an experienced project manager for your clinical trial—or doing everything yourself if you have enough time and expertise—you can ensure that all study efforts move along smoothly, ending with actionable results for drug companies looking to bring safe new treatments to market.

How do you get into clinical trials project management?

When looking for a job in clinical trials project management, it is best to apply to organizations within your geographical area as you may then be able to take on part time work while you are learning on-the-job. Once you have gained experience and achieved success with projects, you can apply for full time jobs with other organizations.

Alternatively, you may wish to work for yourself or set up your own company if there is a gap in the market for your services; however, running your own business does require additional skills. If becoming self employed interests you, be aware that it will require commitment and hard work to succeed but being self employed allows flexibility so if working away from home is important to you then taking on additional freelance projects could suit.

Another way to gain experience is to do internships or clinical research assistant work. Aspiring project managers in clinical trials will find that a lot of trial management jobs require some previous experience and it can be difficult for new graduates to find roles but internships give students an opportunity to try out roles within clinical trials without making a long term commitment; they also make it easier for employers who may not otherwise take on new graduates to take them on as interns are short term and low-risk commitments.

If you would like to be a project manager in clinical trials, then you should consider your strengths and abilities. Consider what subjects you enjoyed studying at school and university and think about what skills or qualities you have that could make you a good project manager in clinical trials.

Think about what personal characteristics would help in your role; for example, extroverts may find it easier to liaise with other departments, whereas conscientious people may perform better at planning. Keep an eye out for job adverts on job boards or visit healthcare organizations to ask if they are looking for project managers. This is also a good way of meeting people who work within clinical trials and gaining more contacts.

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What to know about project management for clinical trials.

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

• Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
• Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
• Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
• Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
• Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively. 

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change. 

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

• Long wait times for IRB approval
• Delays in patient recruitment
• Turnover among site staff
• Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing. 

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

• Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
• Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
• Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
• Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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Clinical Trial Project Management Plan Template

What is a Clinical Trial Project Management Plan?

A clinical trial project management plan is a strategy that combines project management and clinical trial processes. It helps clinical trial project managers and teams to plan and execute clinical trials with greater efficiency and accuracy. This plan includes focus areas, objectives, KPIs, and related projects that contribute to the overall goal of the clinical trial.

What's included in this Clinical Trial Project Management Plan template?

• 3 focus areas
• 6 objectives

Each focus area has its own objectives, projects, and KPIs to ensure that the strategy is comprehensive and effective.

Who is the Clinical Trial Project Management Plan template for?

This plan is best suited for project managers and teams that are preparing for or managing clinical trials. It is an effective tool to streamline clinical trials processes, increase efficiency and data accuracy, and identify and reduce potential risks.

1. Define clear examples of your focus areas

A focus area is a broad category that outlines the main goal of a clinical trial project management plan. Examples of focus areas include project management, quality assurance, and risk management. Each focus area should be broken down into more specific objectives and related projects.

2. Think about the objectives that could fall under that focus area

Objectives are the specific goals that are being targeted in each focus area. For example, an objective in the project management focus area might be to streamline clinical trial processes. An objective in the quality assurance focus area might be to ensure data accuracy.

3. Set measurable targets (KPIs) to tackle the objective

KPIs (Key Performance Indicators) are measurable targets that are set to tackle objectives. For example, for the objective of streamlining clinical trial processes, you might set a KPI to decrease clinical trial setup time. The initial KPI might be 30 days, and the target KPI might be 20 days.

4. Implement related projects to achieve the KPIs

Projects are the actionable steps that are taken to achieve KPIs. For example, to achieve the KPI of decreasing clinical trial setup time, you might create standardized processes. To achieve the KPI of increasing data accuracy, you might implement data validation checks.

5. Utilize Cascade Strategy Execution Platform to see faster results from your strategy

Cascade Strategy Execution Platform is a complete solution for clinical trial strategies enabling project management and quality assurance. Cascade's features help project managers and teams to streamline processes, increase efficiency, and ensure compliance with regulatory standards, resulting in faster and more successful clinical trials.

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Effective Project Management of Clinical Trials

Feature article.

During medical school or post graduate training, we receive some formal training in designing and running complex programs like research projects or clinical trials. For those interested in clinical research, we then spend years learning how to ask good research questions, draft research protocols, apply correct research methodology and write successful grant applications.

Following this path, I was lucky to secure a grant and start a pilot clinical trial involving 30 patients. I thought I had all the right tools, time and resources to successfully conduct this project. However, I soon realized the painful reality of managing a clinical trial – it is incredibly challenging! I encountered multiple early failures like slow recruitment, lack of team coordination and overall inefficiency. It dawned on me that at no point during my clinical career had I received formal training in project management. A project management expert helped me navigate this challenge. In this article, I share my insights on project management not only for clinical trials but also for any type of project requiring the coordination of a team and resources around a specific objective.

Pearl #1: Project management of clinical trials is a science with valuable tools at your disposal. We tend to think the day-to-day business of managing a clinical trial is not the "scientific part." However, project management is a science and has well-defined evidence-based methods. Recognizing this is the first step in successfully managing clinical trials. Learning to harness the power of these tools is the second step. Using tools like chunking , GANTT charts , and resource allocation will organize and simplify the flow of your trial.

Pearl #2: Focus more on human aspects as compared to technical aspects. There are two major aspects of any large project: the technical and the human. As trained scientists, we tend to take the rational approach: "If I have two research nurses available and I am paying for 60% of their full time equivalent from my grant, then they will work whole-heartedly for three days per week on my project and I will finish this project in three months."

The root cause of inefficiency in my clinical trial was not technical, it was me ignoring the "human-side." I was fixated on productivity but overlooked the people working with me – my team. I realized that regardless of the resources and planning, it is the human element that drives successful project management.

• Grow the Team Leader: Building a better team always starts with building a better team leader. Inspiring your team with your hard work, work ethic, compassion, empathy and leading by example can ensure a long-lasting relationship even in challenging times. "Leading means that others willingly follow you – not because they have to, not because they are paid to, but because they want to." – Simon Sinek.
• Know your team: Ask, "What motivates my team to conduct research?" "What is their background, their perspective?" Have an honest conversation and get to know the person behind the title. For example, what motivates those trainees to volunteer their 80-hour work week and sacrifice their weekends to your project? What sparks the interest of your research nurses? Is it just a job requirement or are they passionate about the science? What are your team members' expectations? Answers to these questions will help you build a motivated, hard-working team. "A team is not a group of people that work together. A team is a group of people that trust each other." – Simon Sinek.
• Rapport building: Showing interest in your team member's life not only at work but also outside work helps to create a stronger relationship. While we have multiple project meetings where we discuss progress, timelines and feedback, taking an interest in the person behind the job is essential. Asking about their family, hobbies and how their weekend was is enough to create a connection. A big part of being a scientist is being a good friendly human being first.
• Feedback: It is important to get feedback from team members and always get their input on how to improve workflow and identify gaps between your expectations and their perception. It provides the opportunity to look at things from their perspective and realize their challenges.

Conclusion Project management coaching made me realize that although I was technically competent, I was ignoring the human element of my clinical trial. What did I change? I got to know my team members as individuals. I discovered what motivated each one of them and we worked together to align their roles in light of their strengths and interests. They were helpful in suggesting several quality improvements to the project and our overall workflow and efficiency was much better. I went from frazzled to effectively managing my first clinical trial.

In the end, real life is a lot messier than a mathematical equation. To successfully move a project, program or trial forward, designing it is not enough: plan using the right tools, keep your key stakeholders motivated and informed, and channel your energy into growing a solid team.

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This article was co-authored by Zain Asad, MD, Fellow in Training (FIT) at the University of Oklahoma in Oklahoma City, OK, and Kat Niewiadomska, PhD, ACC Member Leadership Development associate.

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Home / Insights / Project Management Framework and Tools in Clinical Trials

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Project Management Framework and Tools in Clinical Trials

September 29, 2020

Project management’s maturity as a discipline has had wide-reaching effects across most industries.

It’s changed the way people manufacture products, develop software, plan company strategies — and even how clinical trials are conducted.

Here, we explore how the evolution of project management has impacted clinical research, and what aspects of project management trial leaders need to know to be successful.

Meet Your Clinical Project Manager

Because clinical trials have so many stakeholders and moving parts, it makes sense that someone should take responsibility at a project level.

As Genesis Research Services Business and Clinical Research Manager  Dom Bailey  points out, this person — the clinical project manager — is responsible for explicitly laying out the project objectives, scope and stakeholder management plan.

Additionally, the project manager will work with a CRO’s leadership team to ensure things like sufficient recruitment numbers and that the necessary project management tools are in place.

Dalfoni Banerjee  at 3Sixty Pharma Solutions says a good clinical project manager must be able to plan and establish key metrics, communicate very well, and remain oriented on the project’s goals while maintaining flexibility to accommodate any unexpected changes.

For trial leaders, perhaps the most important trait in a project manager is their communication skills. “Nothing is worse than working for an out-of-touch project manager—someone who is lost in the project plan or the study metrics, or making assignments without listening or making any kinds of assessments or mid-course corrections,”  Jim Moat  at IMARC Research writes.

“Someone with a balanced view of the big picture and the smaller, but important, details, is bound to lead a more successful project and team.”

Moat underscores how important relationships are in managing a trial, which means a good PM knows how to listen and is willing to spend time with research staff to understand realities on the ground.

Zain Asad, M.D., and Kat Niewiadomska, Ph.D. , write for the American College of Cardiology that their own experience with project management made them better team members. The PM perspective allowed them to see how each person complemented others and fit into a cohesive team.

The Rising Influence of Agile Project Management in Clinical Trials

Nearly 20 years ago, the  Agile Manifesto  laid out a new framework for developing software by making the production process iterative and dynamic.

Today, that methodology has found purchase across industries, and its principles are nudging clinical project management into new directions.

Most clinical project managers apply agile frameworks in an effort to cut costs and improve efficiencies. That said, aspects of agile such as iterative development and regular opportunities for stakeholder feedback create other opportunities in clinical trials.

As  Syneos Health  notes, an agile approach to clinical trial management can:

• Break up siloed teams and facilitate cross-functional cooperation.
• Upend linear business processes and replace those with opportunities to innovate.
• Center stakeholder needs.
• Facilitate “early and proactive dialogue with regulators to support expedited pathways for bringing new products or innovation to market.”

As promising as that all sounds, though, agile’s uptake has been stifled on a few fronts. In a 2018 dissertation for Harrisburg University of Science and Technology,  Jitendrakumar Narola  surveyed nearly two dozen healthcare IT professionals about their experience with agile projects in clinical trials.

Narola’s research found that many respondents were hesitant to embrace an agile approach to project management because they didn’t feel sufficiently familiar with the framework, or because they weren’t sure how compatible it would be with FDA regulations.

Further, agile transformations are more fundamental undertakings than simply tweaking how a project is managed. “[A]gile methodology is not applicable neither to all parts of a study nor to all kinds of studies, but striving for an agile transformation in an organization as a whole will pave the way in making clinical trials as ‘adaptive’ as possible,” researchers  Katarina B. Pavlović, Ivana Berić and Ljiljana Berezljev  write in the European Project Management Journal.

This, of course, speaks to a larger movement among researchers who lean on  adaptive trial designs  to make data collection and analysis concurrent during an in-progress trial.

The Tools Shaping Clinical Project Management

The fundamental tasks of project management are the same, no matter the industry or the project.

A clinical project manager will specifically need a tool to help with:

• Creating the work breakdown structure.
• Analyzing and mitigating risks.
• Planning budgets.
• Determining milestones and key metrics to track.

This is the kind of work that can be done in a  clinical trial management system  (CTMS). A CTMS should give you space to organize an electronic trial master file (eTMF), which is absolutely crucial in what Jim Moat at IMARC describes as “telling the story of your study.”

“Ensure your trial master file is kept current and complete,” he writes. “ … Make judicious use of notes-to-file and memos to document unusual steps taken in a given situation. As we say at IMARC, ‘you’ve done the work; now write it down to take credit for your work.’”

Further, ensure your CTMS allows you to share documents (or at least integrate with a tool like  Microsoft SharePoint , which facilitates document collaboration), and that it provides a place to track timelines and milestones.

From there, a project manager might opt for a separate project management platform that accommodates their preferred methodology. For example, a tool like  Asana  or  Microsoft Project Manager  can help visualize timelines, budgets and tasks.

Or, if the project manager needs to organize work in a Kanban-style workflow, tools like  Trello  or  MeisterTask  can help visualize those tasks.

Finally, a project manager needs to be able to host and lead meetings, sometimes with remote staff. In such cases, a conferencing tool like  Zoom  or  GoToMeeting  would be useful.

With the tools above and a framework in place, a clinical project manager has what they need to try to steer a clinical trial toward its goals within budget and within expected timelines. Of course, no projects go exactly as planned, so transparency and communication go a long way to getting a trial back on track in the face of unexpected changes.

For clinical trial leaders, having this kind of perspective into the project-management aspects of a trial will be useful in marshalling resources and leading teams as needed.

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Project Management: Introduction to Tools and Templates

By: melissa harris, mpa, ccrp director of interventional resources & clinical trials unit pennington biomedical research center at lsu.

Abstract: Project management involves many complex components and moving parts. Prior to initiating a clinical trial, various types of project tools and templates can be used to successfully plan and execute a clinical trial. This article highlights tools that are readily available for project management, including Microsoft Excel, Access, Visio, Outlook, and SharePoint, as well as Web-based applications. Monitoring progress through various tracking mechanisms ensures successful clinical trial execution from recruitment through retention and follow-up.

Project Management

The project management life cycle for clinical trials is comprised of:

• Study start-up
• Team management
• Clinical assessment
• Intervention.

The project management tools covered in this article are described in relation to the project management life cycle. Examples are from clinical trials in academia; however, the tools can be used in any research setting.

At any given time, the project manager is shuffling plates and trying not to drop one. Project management can be considered similar to riding a bike. The project manager should be able to get on the bike or project and do the same thing on each ride, or in this case, from research project to research project. Unfortunately, in clinical research, the bike is “on fire,” the project manager is “on fire,” and everybody working on the clinical trial is “on fire.” This article provides tools to help douse the fire and continue to move forward on the research project. 

There are many components of a study, from the research idea through analyzing the data and publishing results (Table 1). The most difficult parts of a project are study start-up and keeping the study going when recruitment is not going well. The project manager and study team try to complete the first four components of a study (research idea, protocol, grant, and institutional review board review) in as compacted an amount of time as possible. Sometimes this requires having a very strong foundation. Tools and processes can be rotated from study to study, enabling the project team to move through the cycle fairly quickly.

The clinical trial lifespan includes:  

• Trial initiation and timeline management
• Creating and managing the budget
• Protocol/consent preparations, institutional review board (IRB) submissions, and revisions
• Development of processes and the manual of procedures (MOP)
• Liaison for contracts, subawards, and community partnerships
• Identifying and managing resources (staffing)
• Training/certification plans and tracking
• Ongoing communication and clinical trial oversight.

Tools help project managers calm the chaos of clinical trials. There are many project management tools, including:

• Microsoft Office Excel, Word, Access, Outlook, and SharePoint

Office 365 is not covered in this article, outside of Outlook, however, Office 365 offers a multitude of online apps.

Tools for Study Start-up

Tools for study start-up include organizational charts, timelines, and process flows (Table 2). A research program organizational chart documents a clear chain of command. It can create camaraderie and outlines responsibilities so that staff know to whom to report. The organizational chart also identifies people who have specialized positions, such as blinded staff. Visio is an easy tool to use in developing organizational charts.

Timelines provide milestone time points for various stages of start-up to be completed. They are crucial and should be revised constantly to align with the pace of the study. When developing a timeline, the author starts with the expected date of the first randomization or site activation and works backwards. The timeline maps the amount of time necessary for each step involved in study start-up. The timeline establishes clear goals for study staff so that each staff member knows the due date for assigned tasks.

Process flows, also known as flowcharts, allow a process and the steps in the process to be viewed at a glance. The author uses flowcharts for all extensive processes within a protocol, investigator brochure, or manual of procedures. It is much more efficient to refer to a flowchart when working with a study participant or working on other study tasks than to have to pull out a large document and search for the necessary information. 

Cross-functional flowcharts, also known as swim lanes, demonstrate the process steps in sequential order and show who does each task. Decision channels (yes/no) can also be included in a cross-functional flowchart.

The cycle of implementing the project and maintaining it is extremely important. Implementation must constantly be re-evaluated to determine whether it is working. A project may be working; however, it could be more efficient. Without monitoring, the project manager will never know if project efficiency could be improved. Monitoring includes identifying inefficiencies, assessing the cost-benefit ratios, and monitoring expenses against the budget.

Tools for Team Management

Team management is a major component of running a clinical trial. The author spends much of her day reading emails from people who are updating her on the work that they are doing on a study. This makes it difficult for her to accomplish her tasks for that day. Regular team meetings are an important form of communication. Team meetings can minimize the need for many emails. They can be done electronically, through teleconferences, Web conferences, online reporting systems, etc.

Effective team management also requires ongoing communication with internal affiliates (other departments) and external affiliates (community partners). A 10-minute telephone call twice a month may be sufficient to communicate with internal and external affiliates. Ongoing communication on the study’s outcomes/progress is also necessary with regulators, funders, and other external affiliates.

Document libraries, calendars, and action items are good tools for team management (Table 3). Document libraries provide a central location for all departmental or project-specific files. They may be housed on shared drives such as Google drives or Dropbox. Since these shared drives do not comply with the Health Insurance Portability and Accountability Act, some universities do not allow their use. Universities often use tools such as SharePoint, OneDrive, and Basecamp, which staff can access from anywhere. A document library automatically backs up the documents every night. 

Basecamp allows the project manager to set up study teams and provide different levels of access to documents for different team members. Assignments, schedules, and bookmarking of certain materials can also be done using Basecamp. In SharePoint, the project manager can create folders and list documents. SharePoint and Basecamp both track edits to documents.

Project managers and study staff use calendars, such as Outlook, extensively for scheduling appointments or responsibilities, participant scheduling, and study-specific calendars. Appointment reminder alerts are a key benefit of calendars. The author maintains a personal calendar and a department calendar to oversee staff activities via a central destination to book participant visits and other study related meetings. 

The department calendar is color-coded so that people can easily see the type of visit: green for assessment visits, purple for remote data monitoring, and yellow for phone call visits to name a few examples. Red indicates something important, such as not scheduling participants for visits requiring online RedCap surveys on a day that Internet access will be shut off or when the center will be closed. Calendars also show when staff will be out of the office. Patient identifiers and notes can also be put into calendars so that staff can reference the invite for patient information.

Action items are a key component of team management. Pennington Biomedical Research Center does action items with the Interventional Resources Unit for administrative activities and study specific tasks for every study. Action items clarify tasks to be completed by members of the study team. Each action item is associated with a responsible person and the deadline. If study team members cannot meet their deadlines, they need to notify the author because her deadlines are contingent on team members meeting their deadlines. Action items also increase accountability by providing clear expectations. 

Using SharePoint, the responsible staff member can update action items as she/he completes them so that the author does not to have to receive emails documenting this. SharePoint can also send notifications, emailing a staff member when she/he is assigned to a task. SharePoint can be used to prioritize tasks. This author has experienced a major challenge with Generation X and Z team members is who may have difficulty prioritizing. In the author’s experience, these generations may more often work on the last task assigned to them instead of the most important task.

Tools for Recruiting

Recruitment is the costliest part of clinical trials. Table 4 highlights tools for recruitment:

• Advertising timeline
• Recruitment goal tracking
• Recruitment budget tracking
• Participant flow diagram 
• Enrollment predictions.

The author develops an advertising timeline that is separate from the overall study timeline. The advertising timeline has recruiting and advertising tasks, with color coding for tasks that have been completed, and yield rates of completed events. Pennington Biomedical Research Center does a great deal of community-based recruitment. The yield rates (number of participants randomized) of completed events show the most effective recruitment methods for each quarter or year. This enables staff to repeat the most effective recruitment methods. 

Tracking recruitment goals is very helpful. Many of the clinical trials conducted at Pennington Biomedical Research Center are funded by the National Institutes of Health (NIH) or another government agency or department. These trials have quarterly recruitment goals. The author usually uses more aggressive goals than the NIH’s goals, since it is easier to recruit participants earlier in the grant when the project is novel and exciting to potential study participants that may be reached during the recruitment process.

Achieving recruitment goals requires providing the study team with clear expectations. Tracking enables project managers to assess monthly/quarterly randomization goals to see when the clinical research site was most successful and to identify effective recruitment methods that can be used again.

Tracking spending on recruitment is also helpful. The most expensive recruitment methods, such as television and radio advertising, may not be providing the most participants. Tracking spending and sources of participants enables the project manager to assess the cost effectiveness of advertising campaigns and adjust them as needed. Pennington Biomedical Research Center has different departments for recruitment and advertising. The departments have designated budgets over the study year yet coordinate marketing and outreach activities to maximize recruitment reach. 

The participant flow diagram is one of the author’s most important tools. A participant flow diagram tracks what is happening in real time, allowing project managers to see where participants are in any part of the study flow. It also lets study team members see when potential research participants and enrolled participants are lost due to exclusionary criteria or dropouts. A participant flow diagram documents the ratio of phone screens to randomization and the number of participants in the pipeline.

Screening yields can also be reviewed through the participant flow diagram. Pennington Biomedical Research Center always assesses why the clinical research site is losing potential subjects. This sometimes enables the project manager to make changes. For example, by tracking screening yields, Pennington Biomedical Research Center has found that people were being excluded from a study in the phone screen because they did not understand a question. In response to this problem, the question was clarified. Enrollment predictions can also be done with a participant flow diagram, and the pending pipeline can be assessed. Finally, retention rates can be assessed with the same diagram by looking at the number of completed, anticipated, and pending visits at each follow-up time point. This could allow for the project manager to identify whether a particular follow-up visit is problematic in return rates for study participants. This could lead to more intensive staff contact for said visits to work to improve these rates for future visit windows.

Tools for Clinical Assessment

Electronic case report forms (CRFs), visit scheduling, and visit windows are tools for clinical assessment (Table 5). The world is moving toward electronic CRFs. Some sites and PIs may be reluctant to eliminate paper especially with specific clinical trial populations such as the elderly. However, technology is moving clinical and research practices towards paperless data entry. In this author’s experience, many industry and pharmaceutical clinical trials are paperless or at least using electronic data capture options in many of their trials.

RedCap, built at Vanderbilt University, is a secure Web application for electronic data capture. Various levels of access can be set up for different staff members. Participant self-reported forms captured via surveys are part of RedCap. These surveys can be sent by email. Rather than call participants to collect information such as adverse events and weight, RedCap can send out automated emails on a timer to collect this information. Pennington Biomedical Research Center sets these up in advance and only has to contact participants when they do not complete the surveys.

Visit scheduling windows can be set in various electronic platforms. Pennington Biomedical Research Center uses Outlook or Sharepoint for visit schedules for some trials. The visit schedules show the start and stop time, preventing double booking of staff. If the visit includes laboratory testing, the system can send an alert to the laboratory with an appointment reminder. RedCap also does visit scheduling. The visit schedule can be printed for study participants or for the study folder.

Tools for Intervention 

Real-time data capture, adherence and compliance reporting, and retention tracking are tools for intervention (Table 6). Pennington Biomedical Research Center does many large multi-site exercise clinical trials or trials with many participants. In one study, 300 participants came to the center three times a week. Instead of writing all of the exercise prescriptions and data capture on paper, staff created the Exercise Database for Intervention (EDIN) to capture the exercise data in real-time using laptops on rolling carts. iPads can also be used to collect data in real time.

With real-time data capture, the data are automatically entered into a website or clinical trial management system. Real-time data capture also allows compliance reports to be generated instantly.

Other data capture tools include Fitabase, heart rate monitors, and body trace scales. When Fitbits are used in a study, its Fitabase can be used to look at data for all participants together. Fitabase provides more data than the data that are available on the app. Participants do need to sync their Fitbits in order for researchers to use Fitabase. 

PolarÔ Heart Rates Monitor and Zephyr can be used to monitor heart rates, including monitoring the heart rates of a group of people at once. Body trace scales are sent home with the participants, where they transmit weight wirelessly to Pennington Biomedical Research Center. Study staff can review trends and share individual data with each participant.

Adherence and compliance reporting is necessary because it is important for participants to stay in the study and to comply with the intervention. Project managers and study teams need to monitor compliance. Pennington Biomedical Research Center extracts adherence and compliance information and puts it in a format that will resonate with investigators. Staff create monthly or weekly participant compliance reports depending on the speed of the study. These reports can show what is happening between groups or within a group. 

Since all of the information is in the system, staff can generate reports for participants such as score cards or report cards. Participants often enjoy receiving these reports. If a participant is not doing something well, this is an opportunity for study staff to discuss any challenges and ways to overcome those challenges.

In order to facilitate intervention retention, Pennington Biomedical Research Center does case assessment to identify thresholds for adherence or compliance. Any participant who reaches the threshold for poor compliance is assigned to a study staff member who acts as a case manager and troubleshoots problems.

Staff also assess reasons for poor compliance to identify trends. They adjust screening and/or retention methods based on assessment results. 

The author is often asked how Pennington Biomedical Research Center tracks contacts with research participants. It is important to know why participants miss visits and the number of times that study staff call them. Clinical research sites must have a retention/participant contact system in place such as a SharePoint list. Pennington Biomedical Research Center’s retention/participant contact system lets the author see the visit window and when to call. She assigns a study staff member to call participants on the specified dates.

Take-Home Messages

Clinical research sites should not rely solely on the successes or failures of past programs or models. It is often necessary to tailor tools to a specific study. In order to be successful over time, clinical research sites must establish:

• A strong infrastructure
• Clear operational procedures
• A variety of tools to monitor research programs, study teams, and research participants. 

Continual evaluation and revision of the research program is necessary. If something works very well, keep doing it. If something does not work, reevaluate it and shift to a more effective strategy. Project managers and study staff must be willing to adapt and change. Some study staff members may require more micro-management than others. The author uses electronic platforms to manage study staff, which is less confronting than managing them face to face. 

Project managers should create a versatile study team that matches the needs of the research program and has a great deal of information. Team members will be different. Some may be very technologically savvy while others may not be technologically savvy.

Increasing efficiencies by saving minutes a day does matter. This can reduce staff burden, burnout, and turnover. Project managers and study staff should work smarter, not harder.

Study Components 

• Choose a topic
• Create a hypothesis
• Develop a plan
• Submit a grant for funding
• Submit the protocol for approval
• Market the study to the target population
• Screen potential participants by telephone
• Orient participants
• Obtain informed consent
• Inclusion/exclusion criteria
• Compliance assessment
• Perform initial assessments 
• Conduct study group
• Monitor progress 
• Test outcomes for changes 
• Prove/disprove hypothesis
• Assess outcomes
• Publish findings 
• Outlines chain of command
• Outlines responsibilities
• Helpful for all study staff to appreciate where they fall and where other’s fall
• Provides pre-identified time points for completion of various stages of start-up 
• Establishes clear goals for study staff
• Ever-changing with the pace of the study
• Also known as flowcharts
• Allows process and steps to be viewed at a glance
• Identifies actions within a process in a sequential order
• Provides specifics of process steps with relevant “if, then” scenarios
• Central location for all departmental or project-specific files
• Increases accessibility 
• Increases dissemination of information
• Archived history of all documents, processes, data, etc.
• Document security with automatic nightly backups
• Staff scheduling for designated appointments or responsibilities
• Participant scheduling for appointments or procedures
• Study-specific calendar for meetings, visits, etc.
• Clear assignment of staff to participant visits
• Appointment reminder alerts
• Ease of identifying other staff members’ availability
• Reduces double booking staff and appointments
• Color coding to easily identify appointments
• Clarify tasks to be completed by the study team
• Provide study team pending action items with associated deadlines
• Assign actions items to designated staff
• Increase accountability through clear expectations

Tools for Recruitment

• Timeline of recruitment and advertisement events
• Yield rates of completed events
• Identify and track study recruitment requirements
• Assess monthly/quarterly randomization goals
• Monitor progress
• Adjust advertising campaigns as needed
• Identify and track study recruitment budget
• Assess cost effectiveness of advertising campaigns
• Determines screening yields
• Assess where participants are lost due to dropouts or exclusionary criteria
• Determine ratio of phone screens to randomization
• Stage of the process for pending participants
• Management of N in each arm of the trial
• Follow-up visit completion rates
• Assess pending pipeline
• Use throughput rates to predict enrollment
• Predict quantity needed to reach goals
• Paperless electronic data capture systems
• Participant self-reported forms captured via surveys
• Auto-generated timed survey requests for completion
• Calculated visit windows for follow-up testing
• Tracking scheduled and actual visit dates
• Pending visit reports

Tools for Intervention

• Real-time data
• Easily accessible compliance reports
• Assess participant compliance monthly
• Identify discrepancies and any areas of concern
• Generating reports for participants
• Tracking participants’ attendance and reasons by the individual, group, cohort, month, etc.
• Tracking retention procedures
• Tracking contact attempts during dropout recovery

2 thoughts on “Project Management: Introduction to Tools and Templates”

where is the tools template？

Hey, fellow readers! I just finished reading the article on project management tools and templates, and I couldn’t resist leaving a comment here. First off, I want to thank the author for putting together such a comprehensive and informative piece. As someone who’s relatively new to the project management world, this article was like a goldmine of practical tips and resources.

The way the author explained various project management tools, from Gantt charts to PERT diagrams, was incredibly helpful. I always found these concepts a bit overwhelming, but the article managed to break them down into digestible chunks, making it easier for me to understand their applications. The best part is that they provided links to free templates and software, which is a lifesaver for anyone on a budget.

Moreover, the insights on how to choose the right tools for different types of projects were enlightening. Understanding that not all projects are the same and tailoring our approach accordingly is crucial for success. I’ve already bookmarked this article for future reference and plan to explore the recommended tools further.

Lastly, I want to express my gratitude for the tips on how to collaborate effectively with teams using these tools. As a project manager, fostering good communication and collaboration is essential, and the author’s suggestions will undoubtedly prove invaluable in my journey.

Great job on this article! I can’t wait to dive deeper into project management armed with these newfound knowledge and resources. Keep up the fantastic work, and I’ll be eagerly awaiting more insightful pieces from this blog. Cheers!

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21 Research project management

• Published: February 2016
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What is a project? - Stage 1: Definition: defining and agreeing what the project is about - Stage 2: Planning: planning how the project will be conducted - Stage 3: Implementation and control: running the project - Stage 4: Close out: delivery and the end of the project

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Project Management

According to the Business Dictionary (2010),  ‘project management’  is  organisation of work within time, budget and cost limits . A bad project manager, therefore, can be defined as a manager who is unable to arrange project work according to some or all of these constraints. The reasons for this may be a PM’s lack of experience/knowledge or skills and poor communication between concerned parties (which is also due to insufficient training, SOPs, lack of experience or inability to account for previous failures and success).

As highlighted by Rettig, R.A. (2000, p.129), the importance of project management and oversight is crucial in the environment of prevailing commercial approach in pharmaceutical industry. Though it may be safer for Pharma to manage their own R&D projects internally, it becomes more time- and cost-effective to outsource clinical trial and pre-approval activities to specialized CROs. However, it is true that quality of project management services delivered by CROs is often unsatisfactory due to different reasons (Bryde, D.J. and Joby, R., 2007). Among other reasons for such outcome the authors cite the view of British Standards Institute (2003), according to which project management is a service that must be of an appropriate quality, i.e. must satisfy all participating parties. However, projects (even very similar in many aspects) are also unique and, thus, require individual approach based on previous experience.

Indeed,  reasons for failure of a project  and most  significant elements of project success  can be defined as  symmetrical antipodes .  If one would define what a bad project manager could do wrong to cause a project failure, it is possible to   mention instead what a good project manager would do to make a project successful.  The most important elements of a successful project management are  Quality Assurance and project planning  at each step. So, to avoid problems in project management the following must be taken into account by project management team (or a PM):

Houston, S.M. & Bove, L.A. (2007):

• Consistent methodology
• Definition of a project by  limits of time, cost and performance  (OR by scope, cost and time)

EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.468):

• Team  with sufficient  knowledge and training
• Support  and  back-up of the organisation

Wycoff, 1991 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.469):

• Knowledge that you, as a PM,  can achieve/facilitate achievement of the project            goals
• Planning:  a clear picture for all participants to describe the stage of the project, how  a certain goal was achieved and where/how to move further to reach further goals
• Utilization of project management frameworks, such as PRINCE  (EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S., 1997, p.469)
• Assessment and re-assessment of  risks = development and subsequent adjustment of the initial project plan

Besides, a good project manager would ask him/her-self the following questions and make the answers clear to other team members  (Caan, W., Wright, J. & Hampton-Matthews, S., 1997):

–          Why certain steps are maid =  what result is expected

–           What is required  for goals achievement

–          Who should do what and when:  Development of the Communication Plan

–          Whether everything needed is in place to start

–          When and whether the project is completed

–           What lessons have been learnt from this project

–           What can be done to improve further performance

So, to make a project successful a PM must: be experienced, have appropriate team and support, plan accordingly, communicate, make corrections, learn from previous mistakes/success, implement gained knowledge.

References:

Bryde, D.J. and Joby, R. (2007) ‘Importance of project and project management deliverables in clinical trials’ , R&D Management , 37(4), pp. 363-377.

Business Dictionary (2010)  Project Management  [Online]. Available from:  http://www.businessdictionary.com/definition/project-management.html .

Caan, W., Wright, J. & Hampton-Matthews, S. (1997) ‘Start as you mean to go on:  Project management for beginners’,  Journal of Mental Health , October, 6(5), pp. 467-472.

Houston, S.M. & Bove, L.A. (2007)  Project Management for Healthcare Informatics , Springer (New York), Chapter 1 ‘Project Management Process’, pp. 1-14 .

Rettig, R.A. (2000) ‘The Industrialisation of Clinical Research’,  Health Affairs , Vol 19, Issue 2, pp. 129-146.

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Clinical Trial Templates to Start Your Clinical Research

By Kate Eby | May 13, 2019

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In this article, you will find everything you need to start your clinical research trials, with easy-to-understand guidance and terminology, 26 adaptable templates, and project plans in Microsoft Word, Excel, Project, and SharePoint formats.

Included on this page, you'll find details on what a research protocol is, project management for clinical trials , research compliance templates , and post-clinical study research documentation and templates

What Is the Research Protocol?

All clinical research starts with the research protocol , a document that details all aspects of the trial: its background, rationale, objectives, design, methodology, statistical analysis plan, and organization. With the protocol, you can make sure you protect the participants and collect the data. Using protocol templates, you can start thinking through what you need to meet compliance standards with the Food and Drug Administration (FDA) and clinical study best practices.

‌ Download Research Protocol Template - Word

The full research protocol includes the following sections and topics:

• Title Pages: These pages provide general information about the protocol, including name, number, version number and date, trial phase, investigational product name, investigational new drug (IND) number, sponsor (or principal investigator in academia), funding organization, medical monitor, and coordinating center. The pages include the principal investigator’s signature (or sponsor), as well as site-specific information, such as the agreement, and protocol details. They also detail the study team and site, particularly in the case of multiple teams and sites.
• Objectives: List the study’s primary and secondary objectives.
• Background Information: Describe the problem under study and priority. Include the medical and scientific rationale that justifies researching the problem. Include data from other studies relevant to this proposed research. Include the name and description of the proposed intervention, including the dosage, route of administration, period, and frequency of intervention.
• Study Design: Describe the methodology and how it will answer the study question. This should include the type of study, primary and secondary outcome(s), population, sample size, study location, period of enrollment and follow-up, intervention and route of administration, randomization (as necessary), and any other relevant protocol information.
• Selection and Exclusion of Subjects: Provide statements describing how the participants must meet all the inclusion and exclusion criteria, and list the criteria. Clearly define the study population. For example, list the demographic criteria, required laboratory data, any prior therapies allowed or disallowed, ability to understand and meet all study requirements, if contraception is necessary, exclusion criteria such as specific health status, use of excluded drugs, cancer status, and chemical dependency status.
• Study Enrollment Procedures: Describe the methods and procedures for identifying and enrolling subjects, how they are documented, how consent is obtained, and any randomization procedures.
• Study Intervention, Duration, and Route of Administration: This section should describe each intervention and duration, as well as how each is administered. List expected adverse effects and dose escalation, if applicable. Discuss how the intervention is acquired, stored, and disposed of, as well as documentation for intervention accountability. In addition, note the medications restricted, allowed, and required, along with the extent to which these medications are tracked and documented.
• Study Procedures: This section includes a study evaluation schedule (presented as a chart) and explanations of the required assessments, what each period is, and any special considerations or instructions necessary. These should match what is available in the column headers of the chart above, and they should include information on the screening or baseline assessments, randomization, blinding, follow-up visits, and final assessments.
• Safety Assessment: List any expected adverse events, and how these could be managed. Mention any toxicities seen in earlier IND studies here. Also, include safety measures as identified in laboratory findings, methods and timing for safety parameters based on the risk profile, definitions for adverse events (AE) and serious adverse events (SAE) and laboratory values used to identify their possibility, timeframes for reporting and collecting information on AEs and SAEs, the reporting system, how you will follow up on AEs, and the specific guidelines for independent monitoring.
• Intervention Discontinuation: List criteria for intervention discontinuation and how you could meet them. Also list possible reasons for discontinuation, any modifications to the schedule should it be discontinued, duration of follow-up, any temporary discontinuation criteria, or any evaluations should participants be temporarily or permanently discontinued from the study.
• Statistical and Analytical Considerations: Include primary and secondary statistical hypotheses, why you chose the study design, the primary and secondary outcome measures, and the validity and reliability of these measures. Also discuss sample size and randomization, treatment assignment procedures, how you define the population, any interim analyses, primary and secondary outcome analyses, the statistical methods you use to consider any necessary intervention effect between groups, and if necessary, the expected positive within group correlations among different study arms.
• Data Collection: Detail how you will gather the data, the required forms, how to keep these forms confidential, and what source data to expect. Note site responsibility for data collection and management, and (if necessary) the responsibilities of the coordinating center.
• Quality Assurance: Describe training for study staff, whether there is a control committee and their required practices, any quality control metrics, how you will identify and document protocol deviations, how you will assure protocol compliance, and the schedule for reviews. If you have a manual of procedures (MOP), reference it here.
• Participants Rights: Include references to the Institutional Review Board (IRB) requirements, informed consent documents, procedures for participant confidentiality, and study discontinuation requirements.
• Committees: List any committees associated with the study, along with their roles.
• Publication: Outline the requirements and procedures for publication.
• References: List any citations referenced in this protocol.
• Supplements/Appendices: Include any additional documentation.

To track every aspect of the proposed research for each participant, create a case report form (CRF) that you can use in both paper and electronic formats. With CRFs, you can collect and analyze data for analysis, and then generate a conclusion for your study. For more information on the distinct phases of clinical trials, see “ Understanding the Phases of Clinical Trials .”

Concept Protocol Template

Before you start your full protocol, consider putting together a concept protocol. A concept protocol helps you introduce an abstract project to stakeholders and encourage discussion around the proposed project.

Download Concept Protocol Template for Clinical Research

Phase 1 Clinical Trial Protocol Template

For nonclinical research or clinical trials that are Phase 0 or Phase 1, use this free template. Phase 1 or nonclinical trials do not require the same amount of detail as a full study protocol.

‌ Download Phase 1 Clinical Trial Protocol Template - Word

Research Compliance Templates

By training staff members on the research protocol, you’ll help them meet compliance standards and understand the purpose and details of the study. Use a training log to record all training that the site study staff completes, signing the log entry for verification.

Download Protocol Training Log Template

Excel | Word | PDF | Smartsheet

Protocol Deviation Template

Protocol deviations are inadvertent or unplanned changes or noncompliance with the research protocol. These events do not increase risk or decrease benefit, nor do they impinge on participants’ safety or rights. They do not compromise study data, but you should capture the deviation for reference.

Download Protocol Deviation Log Template

Excel | Word | PDF 

Delegation of Authority Log Template

Once you’ve trained your staff and figured out their roles and responsibilities, the principal investigator must delegate authority. The delegation of authority log should be filled out and signed prior to the study’s start.

Download Delegation of Authority Log Template

Site Selection Visit Form Template

The sponsor must perform a site visit to determine its suitability as part of a multisite study. This means taking a tour to determine whether the site has the capabilities to meet the sponsor’s goals.

Download Site Selection Visit Form Template

Word | PDF  | Smartsheet

Study Site Initiation Checklist

Teams must also perform an inspection to determine if a site has the appropriate staff, training, equipment, and supplies to be part of a multisite trial.

Download Study Site Initiation Checklist

Project Management for Clinical Trials, Practices, Templates, and Documents

Clinical trials are big projects. If the organization is not used to planning and wants to conduct clinical research, it must hire a project manager and work with senior leadership to introduce planning into the organization.

Together, they should develop the main goals and define their limits and the terms of success. They should set out a strategy for which tasks and sets of tasks to perform and in what manner. Test any planning tools or software before the trials start. When possible, use templates to ensure consistency and best practices.

Once the trial starts, evaluate your systems with standardized metrics. The project manager can track study deviations and apply corrective actions. Use the lessons learned from past and current projects to help guide future projects. Employing consistent tools gives you the opportunity to draw from a reservoir of data.

Clinical research can cost billions of dollars and years of time, resources, and effort. As

such, project management best practices and methodologies are critical to the success of a clinical trial, according to experts .

Many software systems are available to manage clinical trials. When very specialized, these are referred to as clinical trial management systems (CTMSs). However, other platforms can also manage clinical trials and may already be embedded with your information technology. Regardless of the platform you use, you should have full project management functionality, such as planning and reporting modules, as well as the ability to track participant contact information, deadlines, and milestones.

You may want to consider the following project management documents for your clinical research.

Project Management Plan (PMP) for Clinical Trials

A PMP delineates and acts as an agreed-upon document of scope, responsibilities, and guidance. You can use it throughout the project to help stay on track. Every clinical trial has difficult milestones, but a good project management plan can help you sidestep some of the regular issues.

You have many PMP software platforms to choose from, but regardless of your ultimate decision, your PMP must focus on protocol adherence, subject care, and service quality, along with how to achieve each standard. Here are the sections you should include in your PMP for a clinical trial:

• Project Objectives: This is an outline of the research objectives for the study, your quantifying standards, and your goals.
• Background and Strategic Context: By documenting background and context, you establish a foundation for decisions and discussion to follow.
• Study Governance: The governance covers the roles and responsibilities in the project, encouraging open communication, sharing, and accountability.
• Stakeholder Management Plan: This plan details how the staff and investigators will collaborate and effectively communication with stakeholders. This could include (as per the roles and responsibilities) regular emails, newsletters, consultation, oversight, training, and documentation.
• Scope: This document delineates assumptions, constraints, and deliverables (and their expected dates).
• Project Risk Assessment: This document helps you prepare for risks and decide on the risk profile.

Clinical Research Project Activity List

A project activity list is an itemized documentation of all the activities scheduled as part of the project. This list should be very detailed, including the status and priority of the task, when it is due, and to whom it is assigned.

Download Clinical Research Project Activity List Template

Excel | Smartsheet

Clinical Trial Timeline Template

A timeline enables you and your staff to track each major portion or milestone of your clinical trial. Your timeline should include these steps:

• Choose Research Questions and Study Design: Research always begins with questions. Your research question will determine how you design your study.
• Choose Outcomes: The outcomes for any trial are dependent on many factors, including scope, health conditions under study, target population, type of intervention. One resource to help develop outcomes is Core Outcome Measures in Effectiveness Trials (COMET) . This database details core outcome sets for comparison in clinical trials.  
• Prospectively Register the Trial: Whether you are working through the FDA, World Health Organization (WHO), or another national agency, study transparency is critical. Prospective registration of trials is recommended. One resource for registration is the ISRCTN registry .
• Obtain Ethics Approval: Any trial involving human participants must go through an ethics review to safeguard the subjects’ rights, safety, well-being, and dignity. There are many options for institutional review, including through a university or a private or governmental organization. Without this step, research cannot commence.
• Prospectively Publish Protocol and Analysis Plan: Before a clinical trial, you must complete some pilot research. When you publish the research leading up to a clinical trial, along with the protocol and analysis for the trial itself, you increase transparency and accountability of the research.
• Planning for the Trial and Data Management: Many clinical research professionals recommend including patients in the planning phase of clinical trials, at least as stakeholders to review the plan. By completing the plan early and allowing potential participants to review it, you help improve recruitment and retention during the trial.
• Recruitment and Retention: Recruitment is getting the right people to take part in your trial, and retention is about keeping their interest and trust. A source of unending frustration for researchers, recruitment and retention can make or break a trial.
• Identify and Manage Trial Sites and Staff: This process is not as straightforward as it is often thought to be. Study coordinators must use feasibility checklists to choose sites and figure out how to get bring on staff who have the bandwidth to recruit for the study.
• Data Collection: The methods for collecting data are critical to any study. Advance planning and structure help you stay organized, comprehensive, and transparent so that your study can have a seamless analysis and solid conclusions.
• Data analysis: Flaws in analysis can generate poor, biased, or erroneous outcomes. In advance, researchers should consider patient blinding, randomization procedures, and sequence generation.
• Findings dissemination: Some researchers recommend threading all research on a trial topic. One resource for this is CrossRef , a database that links similar research. Regardless, the point of research is to capitalize on scientific progress and move it along. By having a plan to disseminate your results, you ensure that others capitalize on your research and move the knowledge forward.

Use this free template to develop your own clinical trial timeline. Add your own steps, milestones, and dates for a comprehensive, expansive view.

Download Clinical Trial Timeline Template

For a different perspective, add your project details to this free template so you can view your timeline visually.

Download Trial Timeline and Graph Template

Microsoft Project Management for Clinical Trials

First released in 1985, Project is a well-respected Microsoft product for project management. Microsoft Project was not traditionally available as a part of Office Suites, a package of programs for professionals and professional organizations. However, Microsoft recently included it as a part of the Windows 2016 suite.

Microsoft Project Management has the following features:

• Built-in templates
• Project portfolio management
• IT management
• Presentations
• Out-of-the-box reports
• Multiple timelines
• Real-time reporting
• Dependency management
• Priority assignment
• Lean management
• Gantt charts/project mapping
• Calendar views
• Setting baselines/KPIs
• Project budgeting
• Issue tracking
• Task creation
• Resource management
• Cloud access

Microsoft Project has built-in templates that you can apply to clinical trial management.

Microsoft SharePoint for Clinical Trials

SharePoint is a collaboration platform that is integrated with Microsoft Office. SharePoint manages and stores documents , and it enables multiple users to access the documents via their own site or a standardized Microsoft site. A subscription to Microsoft Office 365’s SharePoint does not require a server, but customization options are limited; the flexible authentication and authorization systems are built in.

SharePoint Server, available in Standard or Enterprise versions, can be developed as either

virtual or hosted services in a business’s IT department. SharePoint Server enables the organization to control the SharePoint features available to staff, and you can scale it to meet different numbers of users.

Windows SharePoint Services 3.0 is a Microsoft-hosted version that comes with Microsoft Office. Microsoft provides a template in SharePoint for Clinical Trials: Clinical Trial Initiation and Management application template for Windows SharePoint Services 3.0 . You can download and add this template to your SharePoint Services, which enables you to create the following:

• Clinical Trial Protocols: This includes the objectives, study design, project plan, subject selection, and budget.
• Protocol Documents: This includes additional documents relative to your study.
• Calendar: Track milestones in the project.
• Threaded Document Discussions: Team members can start and track discussions within documents.
• Task Creation and Assignment: You can create and assign tasks to users, who receive email notifications.
• Archiving: You can move documents or groups of documents to archive status, keeping them but not making them visible.

The clinical trial template has site lists of libraries for clinical trial protocols, protocol documents, announcements, calendars, issues, tasks, and document discussions. These can be further customized with different versions of SharePoint. To download this template, you will need access to SharePoint Server 3.0.

Clinical Research Budget Plan Template

In many instances, you set the clinical trial budget after much negotiation with a sponsor. Other times, you need to build a budget before the sponsor is even on board, as a way to convince them of the project’s feasibility. The key cost drivers for any clinical research project are the following:

• Patient Grants: These include the costs for screening failures, baseline patient measurements, and procedural costs.
• Site Costs: This covers any expenses associated with the site, such as start-up fees, IRB fees, storage fees, and site management costs.
• Non-Patient Costs: This includes consultation fees, monitoring board fees, and any medical device costs.
• Labor Costs: You must account for all the staff required for the project and their full-time equivalency (FTE).
• Site Management: These costs include pre-study visits, initiation fees, monitoring, and close-out fees.
• Miscellaneous: These include investigator meetings, any technology needs, and ad hoc travel.
• Unexpected Costs: These are costs resulting from protocol amendments, value added tax (VAT), delays, and inflation.

Before you start putting together your research budget, you must gather the following:

• Schedule of assessments from the protocol
• Standard institutional fees from your institution, if applicable
• Evaluation and procedural costs
• Staff allocation and their hourly rates
• Indirect cost rate
• Subject compensation costs
• Data storage fee estimate

Put together your own clinical trial budget with this free clinical research budget template.

‌ Download Clinical Research Budget Template - Excel

Clinical Research Tracking Log Templates

Clinical research requires scrupulous planning, a well-developed team, regulatory adherence, and above all, excellent documentation. It is therefore critical for clinical trial project managers to have a completed scope of work and to develop all the forms and templates before the trial begins. Some of these documents are for planning, and some, like those included below, are for operational purposes.

Regulatory Binder Checklist

Strong clinical practice thrives with a regulatory binder checklist. This checklist keeps track of all paper versions of essential regulatory study documents. Each document should also include any electronic locations. This document should be regularly updated, customized for unique studies, and stored in reverse chronological order.

Download Regulatory Binder Checklist

Clinical Study Document Tracking Log

It is important to not only track all paperwork related to a clinical trial, but also be able to locate it easily between various staff and sites. A clinical trial document tracking log can help you keep a written trail of the documents and when they were submitted and approved. You should also keep copies of the documents with the log. Use this free template to develop your own clinical study document tracking log. You can also adapt the log for specific correspondence, such as documents relating to FDA or IRB submissions, but it should not be mixed with regulatory documentation.

Download Clinical Study Document Tracking Log

Data and Safety Monitoring Plan (DSMP) Template

Before you can undertake a study, you must develop a DSMP for how to keep participants safe and how to secure data and ensure accuracy. The DSMP has several sections:

• The study purpose
• An adherence statement
• Any protocol amendments
• Multisite agreements
• A plan for subject privacy
• Confidentiality during adverse event reporting
• Expected risks
• Adverse events, unanticipated problems, and serious adverse events: how they are defined, their relation to the study, expectations, severity grading, and reporting procedures in single-site and multisite trials, and whether they are IND or non-IND studies
• Events of special interest
• Pregnancy reporting
• Rules to halt the study for participants
• Quality control and quality assurance
• Subject accrual and compliance
• Sample size justification
• Stoppage rules
• Monitoring committee designation
• Safety review plan
• Study report plan for independent monitors
• Plan to submit reports from onsite monitoring and audits
• Data handling and record keeping
• Informed consent
• Reporting changes in study status

Create your own data and safety monitoring plan using this free template. It lays out each section so you can specify them for your research. The principal investigator should sign and date this document once it is complete so that it may be filed.

‌ Download Data and Safety Monitoring Plan Template - Word

Research Communication Plan Template

A communication plan should describe how you will converse with internal and external stakeholders during your project. Your communication plan should include a brief overview of your project and a breakdown of the messages you need to get out. You should adapt the messages for different audiences and define who will deliver these messages. The messages should include the following:

• The purpose and benefits of the research
• The known effectiveness of the intervention, or (if the intervention is under study) the disclosure that the effectiveness is unknown
• How participants will be protected
• The risks and benefits of participating

Develop your own communication plan using this free clinical trial communication plan template. This template also includes a section for situation analysis and risk analysis that asks for inputs on strengths, weaknesses, opportunities, and threats.

‌ Download Clinical Trial Communication Plan Template - Word

Participant Management in Clinical Trials Using Templates

A few main documents help ensure that your participants are tracked and well-cared for before and during your research study.

Enrollment Log for Clinical Trials Template

This log keeps track of everyone that has been enrolled for participation in your study. This does not mean that they have met the eligibility requirements or have been otherwise screened, but it is a record that they have signed up to be admitted.

Download Enrollment Log for Clinical Trials Template

Informed Consent Form Templates

Informed consent is the central tenet of ethical research with human subjects. The consent process typically involves a researcher delineating what is involved in the study, its risks and benefits, what a participant’s duties entail, and answering any questions they have. Before you perform any research, make sure the informed consent document is signed and the participant receives a copy, unless the informed consent document has been waived by an institutional review board (IRB). Federal regulations 45 CFR 46.116 govern what you must provide in the informed consent process in the United States.

To prepare informed consent documentation, researchers must do the following:

• Use plain, easily understandable language no higher than an 8th-grade reading level.
• Tailor documents to the potential population.
• Avoid technical jargon.
• Use the second or third person (you/he/she) to present study details.
• Include a statement of agreement.
• Ensure that the consent document is consistent with information in the IRB application.

These templates assist the principal investigator in the design of their informed consent forms (ICFs). You can adapt them to accommodate the details of any study and include both the information sheet and the consent form. Modify each section with the appropriate description described in italics. Use the general template for any type of research.

‌ Download General Informed Consent Template - Word

Use the clinical trial template for medical research.

‌ Download Informed Consent for Clinical Trials Template - Word

Eligibility Criteria (Inclusion/Exclusion) Checklist

Eligibility criteria are an essential part of clinical trials. They define the population under investigation.

Inclusion criteria are the standards that participants must meet to enroll in the study. For example, in a study on a new diabetes medication, you would likely want participants who have already been diagnosed with diabetes.

Exclusion criteria specify the characteristics that disqualify participants from taking part in the research. For example, in the diabetes study above, the proposed diabetes drug may target a specific age demographic. One exclusion criterion could be a participant whose age falls outside of the range.

Download Eligibility Checklist Inclusion-Exclusion Template

Concomitant Medication Log Template

Properly documenting any medications that participants are taking is imperative to understanding the reactions occurring in their bodies, as well as what could spur adverse and severe adverse events during the study. Fill out a concomitant medication log for every participant and account for everything participants take, even seemingly innocuous items like multivitamins.

Download Concomitant Medication Log Template

Excel | Word | PDF

Adverse Event Form

Clinical research can result in complications for the participants and trigger an adverse or severe adverse event. An adverse or severe adverse event is when participants in a clinical trial have negative medical symptoms that can be shown in laboratory or physical testing. Each participant in a clinical trial should have an adverse event log that tracks any adverse events through the duration of the study.

Download Adverse Event Form Template

Severe Adverse Event Form

A severe adverse event (SAE) is a special case of an adverse event in which the outcomes are acute. Examples of SAEs include death, life-threatening complications, or anything leading to immediate hospitalization, physical disability, or congenital abnormalities. Log SAEs in the AE form, but fill out an additional SAE form.

Download Severe Adverse Event Form Template

Word | PDF | Smartsheet

Post-Clinical Study Research Documentation and Templates

After you complete or terminate a clinical trial, you should prepare several additional documents. Here are some examples of this documentation:

• Investigational Product Accountability Log: You generally provide an accountability log to the authorities that tracks drug products to show product disposition and accountability per participant. It also helps you track the drug product stock and any imbalance at the end of the study.
• Investigational Product Destruction: Due to regulations governing the proper disposition of investigational products in clinical research, you must properly dispose of products left at the end of a study (as evidenced by the product accountability log). This form describes and ensures that you have properly handled any leftover products.
• Close-out Checklist/Report: A study close-out checklist and report helps ensure that you complete all closing procedures, archive the paperwork, and resolve electronic data.

Clinical Study Summary Report Template

Assemble the summary report at the end of a study to get results into the sponsor’s or public’s hands while you complete the full report. A summary report is typically about 2-3 page-long document that encompasses the highlights from the trial.

‌ Download Study Summary Report Template - Word

Clinical Study Report (Full) Template

The full clinical study report (CSR) encompasses all aspects and details of the research you’ve conducted. It is not a sales or marketing tool; instead, it is a scientific report details the methodology and shows scientific rigor.

‌ ‌Download Clinical Study Report Template - Word

Public Links and Resources for Clinical Trials

The following are publicly available resources, tools, and links for clinical trial practitioners and principal investigators:

• PROMIS : Patient-Reported Outcomes Measurement Information System (PROMIS) software gives clinicians health status patient measures that are physical, mental, and social patient-reported metrics. Funded by the National Institutes of Health (NIH), PROMIS can be used in clinical trials as measures of conditions and disease and as a comparison to the general population. The measures in PROMIS are free to administer on paper, by computer (computer adaptive tests), or with an app. The computer adaptive tests may be conducted on REDCap , Assessment Center , or Epic .
• REDCap: REDCap (Research Electronic Data Capture) is an electronic data capture system that works on browsers to develop research databases. It was developed at Vanderbilt University to support clinical research data collection and is a free resource to nonprofit organizations. It is limited to organizations joining the REDCap consortium and is not open-source or available for commercial use.
• Good Clinical Practice (GCP) Training: GCP is an international quality standard designed for use by staff involved in clinical trials. The guidelines for this are from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These regulate the ethical guidelines, documentation, record keeping, training, facilities, technology, and inspections. The purpose of these guidelines is to keep clinical trials scientifically rigorous and to delineate the roles and responsibilities of research staff. The National Institutes of Health administers training for GCP.
• Quality Management Study-wide Review Tool: Developed by the NIH, this review tool is for PIs and study teams to manage their quality reviews, and may be customized for unique studies.
• Quality Management Subject Review Tool: Also developed by the NIH, this review tool provides study teams the structure for review of participant data, and may be customized for the unique study. This should be developed in concert with the DSMP.
• AccrualNet: AccrualNet is sponsored by the National Cancer Institute (NCI), and offers advice and training to staff on how to recruit study participants.
• Regulatory Education for Industry (REdI): The FDA offers a Clinical Investigator Training Course for researchers conducting investigational new drug (IND) or device exemption (IDE) studies.
• ResearchMatch: Available to volunteers and researchers affiliated with the NIH Clinical and Translational Science Award (CTSA) program, this site helps match prospective participants with specific studies.
• Grant Policies and Guidance: The NIH and National Center for Complementary and Integrative Health (NCCIH) offer links to many resources that are policy- and grant-specific to the NIH and NCCIH, updated regularly.
• Protocol Amendments: The NIH and NCCIH offer regularly updated guidance for NIH policy and protocol changes.
• Clinical Terms of Award for Human Subjects Research: The NIH and NCCIH offer guidance for clinical trial grant awardees for compliance.
• NIH Single IRB (sIRB) Policy for Multisite Research: The NIH offers a FAQ page for multisite research that includes policy, contract and application information, responsibilities, exceptions, and costs.
• Dictionary of Cancer Terms: The National Cancer Institute (NCI) offers a dictionary of cancer terms for researchers and laypersons. You can add this dictionary to your website as a widget.
• Informed Consent FAQs: The U.S. Department of Health and Human Services (HHS) and the Office for Human Research Protections (OHRP) offer a FAQ page about informed consent for researchers and lay persons.\Informed Consent Language (ICL) Database: The National Comprehensive Cancer Network (NCCN) offers a database to help write informed consents. This database is specific to medical conditions and different risk language.

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Introduction to Clinical Research Project Management

Clinical research is pivotal in advancing medical knowledge and improving patient care. It involves the systematic investigation of new treatments, interventions, and healthcare practices. However, conducting clinical research requires careful planning, coordination, and management. This is where clinical research project management comes into play.

Defining Clinical Research Project Management

Clinical research project management is a specialized discipline that focuses on planning, organizing, and overseeing the various aspects of a clinical research study. It involves managing a wide range of tasks, including study protocol development, participant recruitment, data collection, monitoring, regulatory compliance, budgeting, and timeline management.

Project management plays a crucial role in clinical research, ensuring the successful execution of studies and the generation of reliable and meaningful results.

Stay informed about our upcoming in-person gatherings and educational webinars. Visit our clinical research events calendar to learn more and register for events.

The importance of project management in clinical research can be understood from the following perspectives:

Study Quality and Integrity

Effective project management helps ensure the quality and integrity of clinical research studies. Project managers work closely with researchers to develop robust study protocols, establish standardized procedures, and implement quality control measures. They ensure that the research is conducted in accordance with scientific standards, minimizing bias and increasing the reliability and validity of research findings.

Participant Safety and Ethics

Clinical research involves human participants, and their safety and well-being are of paramount importance. Project managers play a vital role in safeguarding participants’ rights and ensuring ethical conduct throughout the study. They ensure adherence to ethical guidelines, obtain necessary regulatory approvals, and implement protocols to protect participants from potential risks or harm.

Timely Execution

Clinical research projects often have strict timelines and deadlines. Effective project management ensures that studies progress according to the planned schedule, avoiding unnecessary delays. Project managers develop comprehensive project plans, identify critical milestones, and coordinate activities to keep the research on track. Timely execution is essential for the availability of research outcomes and potential interventions promptly.

Resource Optimization

Clinical research projects require various resources, including personnel, funding, equipment, and facilities. Project managers are vital in resource management, ensuring that resources are allocated efficiently and utilized optimally. They identify resource requirements, secure the necessary funding, coordinate personnel allocation, and make informed decisions to optimize resource utilization, ultimately maximizing the efficiency and cost-effectiveness of the research project.

Risk Management

Clinical research projects are subject to various risks and challenges impacting the study’s progress and outcomes. Project managers proactively identify potential risks, assess their potential impact, and develop risk mitigation strategies. They implement measures to prevent risks or address them promptly if they arise. Effective risk management minimizes disruptions and ensures that studies proceed smoothly, thereby safeguarding the integrity of the research.

Collaboration and Communication

Clinical research involves collaboration among multiple stakeholders, including researchers, study coordinators, ethics committees, regulatory authorities, sponsors, and participants. Project managers serve as a central point of contact, facilitating effective communication and collaboration among these stakeholders. They ensure that all team members are well-informed, aligned with project goals, and working cohesively towards the successful execution of the research project.

Regulatory Compliance

Clinical research is subject to a complex regulatory environment, with strict guidelines and requirements. Project managers are responsible for ensuring compliance with applicable regulations and obtaining necessary approvals and permits. They stay updated with regulatory changes, coordinate with regulatory authorities, and ensure that the research adheres to ethical and legal standards. Compliance with regulations is crucial for the credibility and acceptance of research findings.

Stakeholder Management

Successful clinical research project management involves engaging and managing relationships with various stakeholders. Project managers collaborate with researchers, sponsors, ethics committees, regulatory authorities, and participants, among others. Effective stakeholder management builds trust, facilitates cooperation, and enhances the overall success of the research project. It also sets the foundation for future collaborations and research endeavors.

Project management is vital in clinical research to ensure study quality, participant safety, timely execution, resource optimization, risk management, collaboration, regulatory compliance, and stakeholder management. By applying project management principles and methodologies, project managers contribute significantly to the successful execution of clinical research studies, ultimately advancing medical knowledge and improving patient care.

Clinical Research Project Managers (CRPM) was established to bring together clinical research professionals who oversee activities in clinical research that utilize project management tools or methodologies to assist them in achieving project deliverables on time and on budget. CRPM aims to connect members of the clinical research project management (CRPM) community through online groups, in-person meet-ups, monthly webinars, and retreats that target the growth of CRPM’s network throughout the clinical research industry.

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Project Management Best Practices™

For employers looking to expand project management skills across the entire study team, this training program delivers practical, hands-on training specific to clinical research..

This is an intensive two-day course which provides detailed and practical guidance on the different project management skills used by study sponsors and Contract Research Organizations (CROs), so helps you decide how to apply these skills in your situation. The course is specifically designed for clinical research project management, with examples and exercises developed using pharmaceutical research scenarios. A key component of this course is that you will learn how to take control of your clinical trials, to manage and direct them, rather than simply tracking what is happening.

Attendees new to project management will receive an introduction to the project management of clinical trials, whereas those more familiar with project management will receive a boost to their knowledge and further their understanding of how sponsor and CRO companies operate.

Learning Objectives

• Define project management and understand the differences between the role of project management and a senior clinical role.
• Apply measurement and control to project timelines, tasks and staff resourcing.
• Describe different management methods and how they operate to achieve project control.
• Cite aspects of project management from budget management to operational delivery.
• Properly document your project management systems and procedures.

Clinical research professionals interested in enhancing project management skills or moving into a project management role.

• Clinical Study Resources

Project Management: Guides to the Basics

Project management tools and principals are used successfully in business to manage goals and objectives to meet expectations of deliverables: product quality, timelines and cost.   We in research know how complicated it is to get from “idea” to completed study publication.   Experience shows us project management skills and tools can help streamline the research process and use your time more effectively through a planned, methodical approach;  a little like applying the scientific method to study start-up, recruitment, study conduct and closure!

Our four modules (15 minutes a day) provide an introduction to the basics of project management with skills, tools and local resources you can use immediately.

Additional Project Management Resources

If, after finishing our  Project Management: Guides to the Basics series, you want to learn more about the discipline of project management, consider these courses:

Project Management for Clinical Research Professionals – ACRP

Project Management Certificate Program – DIA

Project Management Certificate Program – the Pharmaceutical Education & Research Institute

Project Management Professional Certification – The Project Management Institute

Postgraduate Certificate in Clinical Trial Management – Parexel

30-Hour Clinical Project Management Fundamentals Certification Program – Barnett International

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Managing clinical trials

Barbara farrell.

1 National Perinatal Epidemiology Unit CTU, University of Oxford, Oxford, UK

Sara Kenyon

2 School of Health and Population Sciences, University of Birmingham, Birmingham, UK

Haleema Shakur

3 Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK

Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Introduction

Over the past 50 years, eminent trialists have written persuasively and repeatedly of the need for large, randomised, controlled trials [ 1 ], and such trials are considered the highest level of evidence for guiding clinical practice. However, how to manage these important trials has had little mention in most commentaries. Many clinical trials fail to deliver because of the lack of a structured, practical, businesslike approach to trial management. The human and financial resources for conducting a randomised trial is finite, so it is crucial that every effort is made to ensure that a trial is implemented simply and managed efficiently. A randomised trial involves a huge investment of time, money and people; therefore, it warrants expert management and needs to be managed from its inception like any other business. To review the literature, develop a protocol, apply for funding and design data collection forms requires lengthy consultations and a considered approach. Rarely is this essential depth of thinking applied to how the trial will actually be managed. Trial management is essential amongst the key competencies that are needed to deliver high-quality trials. It is recognised that well designed trials are the basis for addressing important clinical questions, but science alone will not be sufficient to successfully deliver a trial. Once the science is determined and the trial accepted through the peer review process, the challenge is quite different. The key challenge is then to establish and implement management systems and techniques that are effective and responsive to the needs of the trial and the trialist [ 2 ]. Clinical trials all require the same coordinated processes and systems, regardless of the size, scope, costs or duration.

An analysis of 114 multicentre trials funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) and UK Medical Research Council (MRC), STEPS [ 3 ], showed that 45% failed to reach 80% of the prespecified sample size. Less than one third of the trials recruited their original target number of participants within the time originally specified, and around one third had to be extended in time and resources. One factor observed in trials that recruited successfully was that they had employed a dedicated trial manager (odds ratio: 3.80, 95% CI: 0.79 to 36.14; P = 0.087). The STEPS collaborators suggest that anyone undertaking trials should think about the different needs at different phases in the life of a trial and put greater emphasis on 'conduct' (the process of actually doing trials) [ 3 ]. In addition, the MRC acknowledged that the failure of some trials can be due to practical problems with trial management rather than scientific problems or problems with the trial design [ 4 ]. Francis et al. [ 3 ] examined whether clinical trials could be considered from a business management perspective and proposed that the dimensions of running a successful trial includes 'marketing', 'sales' and 'ongoing client management'. They recognised that in the recruitment stage of a randomised controlled trial (RCT), the most demanding activity is to establish and implement a range of effective management techniques which parallel those used to run a successful business.

What makes a successful trial?

Prescott et al. [ 5 ] assembled and classified a comprehensive bibliography of factors limiting the quality, number and progress of RCTs. They identified barriers to clinician participation that included, for example, time constraints, concern about the impact on doctor-patient relationships, concern for patients, lack of reward and recognition, and an insufficiently interesting question. Barriers to patient participation included issues such as additional demands of the trial, patient preferences, concern caused by uncertainty and concerns about information and consent. They recommended that to overcome barriers to participation, a trial should address an important research question and the protocol and data collection should be as straightforward as possible, with demands on clinicians and participants kept to a minimum. Dedicated research staff may be required to support clinical staff and participants. The recruitment processes of an RCT should be carefully planned and piloted regardless of size or complexity.

On the basis of experience in noncommercial academic initiated trials, Farrell and Kenyon [ 6 ] in The Guide to Efficient Trial Management suggest that actively managing every aspect of the trial is key to success. If clinicians are to recruit participants, they should feel comfortable and trained in trial processes and procedures. This can be achieved using a variety of methods: one-to-one training, group work, distance learning methods (videos via the web and teleconferences). National and international presentations and discussions to continually highlight the importance of the trial must be organised by the trial team. Maintaining a personal interface with a collaborative group of clinicians, whether this is a group of 7 or 700, is probably the biggest challenge for a trial manager and the trial team but one that will result in a more cohesive trial.

A trial manager

The importance of a trial manager to the success of the project is recognised by the NIHR HTA programme, and they recommend that all primary research projects appoint a dedicated project/trial manager. Ideally, trial managers should be involved early on in the trial design phase, but this is rarely possible because of funding constraints. However, a good trial manager involved in the trial design and funding application will make a valuable contribution to the practicalities of conducting the trial, potentially saving money and avoiding unworkable systems. Generic job descriptions produced by the HTA [ 7 ] and the UK Trial Managers' Network (UKTMN) [ 8 ] identify the key responsibilities of a trial manager as follows:

• Having a leading role in planning, coordinating and completing a project

• Excellent communication and presentation skills

• The ability to organise and motivate others

• Flair, enthusiasm, innovation and leadership when faced with challenges

• The ability to manage the trial budget(s) and maintain the accounts

• Having strategic, tactical and operational management skills in the planning and execution of a project

Despite the complex responsibilities of this role, the body of knowledge available to guide trial managers is very limited. In 1998, Farrell [ 9 ] described the need for trial management models and methodology to be established, recognised and published to provide a body of evidence for those undertaking clinical trials, large or small; yet more than 10 years on very little recognised reference material, other than The Guide to Efficient Trial Management [ 6 ], is readily available. In addition to a trial manager, an efficient, well-trained trial management team can be the deciding factor in the success or failure of a trial. The trial team will be decided by the needs of the trial itself and, apart from the Chief Investigator, it should include a trial manager, a trial statistician, a trial programmer, a data manager, data clerks, administrative staff and other trial specific staff, e.g., health economists. Each of these has an important role to play, and clarity about exactly what each of the roles involves is crucial if every aspect of a trial is to be managed well; it requires a team effort. In the UK, the recent development of research networks and the registration of Clinical Trials Units has seen the 'portfolio trial manager' emerge. The portfolio manager has to deal with a variety of tasks across a range of trials which can present different challenges. The success or failure of this approach will become apparent over the coming decade.

Project planning

A clinical trial shares many features with any other type of business project as defined in the field of project management [ 10 ]. These features include the following:

• A clear objective aimed to bring about change

• Requiring a team

• A set time scale

• Defined resources to achieve its objective

• Tasks which need to be completed (to a prespecified standard)

All projects consist of a series of processes, a set of actions to bring about results. The five basic process stages are [ 10 ]:

1. Initiating

2. Planning

3. Executing

4. Monitoring and controlling

5. Analysis and reporting

These five stages reflect the life cycle of a trial. Therefore, developing a management plan is key for effective trial management. It is essential that a project management plan include details of the arrangements for developing and monitoring all aspects of a trial, including servicing the steering committee and the independent data monitoring committee but, most important, how the day-to-day running of the trial will be planned and managed. The development of a robust statistical analysis plan supported with sufficient resources and time to conclude the trial efficiently is a crucial element of this plan. The project plan should also describe who will be responsible for essential activities, such as staff recruitment, staff management, communication with the collaborative group, recruitment monitoring, data management, and raising project awareness (promotion), through to safety reporting, analysis, report writing and dissemination of the trial results. The project plan should describe what the trialists are trying to achieve, how resources will be used and within what time frame. It should also include how the planned processes will be monitored to ensure that the project is being delivered as planned. The plan can then be reviewed and refined, if necessary, as the trial progresses. Clear processes, both inside and outside the office, need to be established and documented. The ability to constantly review and adapt the project plan is crucial as a trial can be hit side-on by events outside its control, e.g., emerging evidence, war leading to lack of recruitment and natural disasters. Sensible risk assessment, tailored quality assurance management systems and real-time monitoring are essential if a trial is to optimise its potential and provide reliable evidence.

The Clinical Trial Toolkit [ 11 ] was developed in 2003 to coincide with the implementation of the EU Clinical Trials Directive [ 12 ] by the UK Medical Research Council (MRC) and the UK Department of Health as a tool to guide people embarking on a clinical trial through the regulatory and governance requirements. The toolkit is a good starting point for trialists and trial managers to ensure all legal obligations are met, but it does not specify how to run a trial.

Collaboration

Good evidence that the clinical question being evaluated is in equipoise is important, but it is only part of the equation. The question also needs to be relevant to clinicians and nurses as they are likely to be the people recruiting the participants. To be successful, most trials depend on developing some sort of collaborative group. The aim of a collaborative group or network is to be inclusive rather than exclusive. Proactively raising the profile of any developing project and creating a group of interested people takes time and commitment. This can be done in many ways, through personal contact, presentations at relevant conferences, mailshots, newsletters from the professional colleges, journal articles and general word of mouth. The success of a trial, particularly recruitment, may require thinking 'outside the box' and training, supporting and crediting other groups who are not traditionally directly involved in the research process but nevertheless are crucial to a trial: for example, nurses, records department staff, ward clerks, radiology staff. A trial is likely to be more successful, and enjoyable, if members of the collaborative group feel they 'own' the project. This ownership will be fostered by involvement and consultation at every stage, from protocol development to publication of the results. All trials need to be actively promoted or marketed. Part of this strategy will be a memorable name and/or identifiable logo and a thoroughly professional image. It is well established that interdisciplinary collaboration offers greater potential for success [ 13 ]. For large trials, this will be a diverse multidisciplinary group including representatives from each participating site. For smaller and single-centre studies, the group will be less formal and may be just a handful of like-minded people. Bammer [ 14 ] identified that there is a growing body of research on collaborations which include examinations of the increase in collaborations and team sizes, patterns of collaborative networks, motives, choices and strategies for collaboration, the measurement of collaboration, how collaborations are organised and how successful collaborations are measured. However, how these concepts are applied to trial management is unclear, and further observation and evaluation are necessary but difficult to carry out. The only reliable way to obtain good evidence that business concepts work in a clinical trial would be to conduct a randomised trial. One half of the trial would be managed according to a project plan and the other half left to run without a plan; we suspect this would be unacceptable to any funder and certainly unacceptable to a good trial team. Some elements of trial management may be easier to evaluate, such as the best method of ensuring data are completed and returned, but once again this carries an element of risk (as does any trial) and will have resource implications.

Minimal work for investigators and participants

Minimal work for investigators and participants means ensuring recruitment procedures run alongside routine practices. Site visits and talking to staff in the place where recruitment happens will make sure recruitment to the trial becomes part of the daily routine. The recruitment procedure needs to be realistic and practical; for example, web randomisation may not be practical for a trial being conducted in an Intensive Care Unit or in a trial of an emergency intervention. Clinical staff are always busy and may be reluctant to carry out complex procedures to recruit participants. Complicated procedures and extra tests or visits may also deter the enthusiastic participant. The data that need to be collected to answer the clinical question should be readily available to the recruiting staff.

Development of the data collection forms should begin early in the process of trial development. Ideally, dummy tables that reflect the final analysis would be prepared as part of the statistical analysis plan to ensure that the data collection forms do not collect unnecessary data. This takes considerable discipline but will avoid omissions in the data collection forms and minimise the collection of data that will never be reported. Experience has generated some simple tips for the design of data forms such as always collect the raw data; if necessary, it can be put into categories later. Questions should be ordered in a way that reflects clinical progression and makes sense to the person completing the form. Data collected as 'free text' is not advisable, as this can considerably increase the data management workload and increase the risk of misinterpretation of the data, but is nevertheless sometimes unavoidable. A recent article by Edwards [ 15 ] provides a theoretical guideline for questionnaire design and administration but acknowledges that further evaluation is required.

Communication

Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy. Remembering the audience being addressed and tailoring all communication appropriately will help busy clinicians identify his or her priorities and maintain trial 'buy-in'. Using an investigator's preferred method of communication (telephone, email, letter, web site and personal contact) will ensure he or she feels communication is personal. Projecting a positive image about trial progress generally as well as progress within any given site will encourage continued involvement. Listening to problems and resolving any issues quickly will increase confidence in the trial and the trial team. Investigators should always be made to feel appreciated and not over burdened by involvement in the trial.

Efficient systems

A trial, particularly a large trial, needs robust computerised systems and procedures that monitor every aspect of the day-to-day running of the trial. A reliable system that will monitor recruitment, randomisation procedures, stock control, data management, data cleaning, and central data monitoring and that will produce useful reports should be developed. Every essential piece of paper that relates to a trial participant should be logged and tracked through the system. There needs to be a logical and transparent structure, concise documentation (standard operating procedures) and accountability of every process employed in the trial. If the trial is international, these systems should take account of differing clinical practices, working environments and governance regulations.

Good quality data depend on effective trial management. Collecting data by the use of a case report form and entering it into a database are quite simple tasks. However, ensuring that these data are sensible, reliable and reflect the 'true situation' is a complicated and detailed process. With the aid of computers, data validation and quality control can be quick and efficient, but these systems also need to be flexible and adaptable so that they can respond to the needs of the investigators and the changing needs of the trial. Using systems that reduce the number of steps required for data entry, such as the use electronic data capture, can minimise the workload for both investigators and the data management team. However, if trialists intend to use electronic data capture, a good deal of preparatory work needs to go into form design and training to avoid adding to the workload. Adherence to database design, testing and validation standards is crucial during the computer system development process and required under clinical trials legislation [ 16 ].

Efficient recruitment of trial participants

A trial succeeds or fails on the basis of whether it manages to recruit the prespecified number of participants to reliably answer the question, and yet there is very little research evidence to guide recruitment strategies. Mapstone et al. [ 17 ] identified 15 eligible trials aimed at recruiting participants for health care studies. Trials of monetary incentives, an additional questionnaire at invitation and treatment information on the consent form demonstrated benefit. However, these specific interventions from individual trials are not easily generalisable. The authors concluded that on the basis of this evidence, it is not possible to predict the effect most interventions will have on recruitment. A Cochrane review on incentives and disincentives to participation by clinicians in RCTs by Rendell et al. [ 18 ] found 11 relevant observational studies relating recruitment rates to a number of factors. In particular, these studies suggested that there was more recruitment if the clinician

• Was interested in evidence based practice

• Was participating in an academic group

• Had extra staff to help with recruitment

• Thought patients might be interested

• Felt comfortable about explaining trials

Although these may provide some pointers for areas to address, the review authors concluded that the research evidence base for strategies for increasing recruitment was poor and that further research was needed. Experienced trial managers, who have learnt through apprenticeship, continually monitor, review and revise the recruitment strategies being used, and this body of experience has been published online as part of The Guide to Efficient Trial Management [ 5 ]. To maintain recruitment at the necessary level over a long period of time, say, 3 to 5 years, requires stamina in everyone involved in a trial. Strategies used to do this might include visiting sites where the trial is working well and seeing what lessons can be learnt and applying them elsewhere. Using the experiences of individuals within the collaboration who are doing well to teach others, either in newsletters or at meetings, is very valuable and encourages internal collaboration and capacity building. Ensuring there is always clear, professional literature regarding the trial at recruiting sites is a task that a good trial manager will incorporate into the project plan. If promotional material is not updated regularly with new eye-catching information, it quickly becomes just part of a sea of other information and all impact is lost. Making sure the trial team go to meetings prepared, i.e., knowing how sites are recruiting, the quality of the data collection and who are the most important people to meet to discuss the trial's progress, should be a 'given', but this is not always the case.

Publication and dissemination

How credit for the trial will be shared is also an important component of the project development and management plan. For collaborative trials, it is vital that appropriate credit is given where it is due and that everyone who has wholeheartedly contributed gains recognition in one way or another. This will often mean publication of the results as a collaborative group. Group authorship is a particular issue for trial managers as under the collaborative authorship policy rarely does the trial manager get acknowledged for their individual contribution. This is a real concern for those working toward making trial management their career pathway and those working to promote a career structure for trial managers.

The trial will mean nothing if the results are not disseminated and taken account of in clinical practice. Results of a trial can be made widely available using a variety of media, such as articles in medical journals, online journals, trial registers, systematic reviews and conference presentations. An advantage of a multicentre trial is that each investigator, working within an agreed policy, can be responsible for local dissemination and presentation. Trial results should be published whatever the outcome of the trial, and it has been described as scientific misconduct not to publish [ 19 ]. Reporting the results must maintain confidentiality, and it must not be possible to identify individual participants or sites within the report. The CONSORT Guidelines [ 20 , 21 ] provide a standard for reporting clinical trials which aims to improve the quality and transparency of trial reporting.

Education, training and experience

The EU Clinical Trials Directive 2001 [ 12 ] specifies that every member of a trial team should have the appropriate education, training and experience to perform his or her tasks. For a trial manager of any trial, it is difficult to comply with this regulation as specialised training in trial management does not exist and there is no recognised qualification that can prove that a trial manager has been educated in the discipline. Much of the collective wisdom about doing trials has been passed on by apprenticeship, very much a 'suck it and see' approach which can be to the cost of the trial and the trial manager. For those wishing to pursue a career in trial management, the lack of good practice guidelines and standards can be extremely challenging and at times very frustrating. A survey undertaken by the UKTMN in 2005 identified the need for courses in practical management of clinical trials. Of the 284 trial managers surveyed, 60% were not seeking higher education qualifications but wanted flexible, accessible, specific training relevant to their jobs. For those who do want to study for a higher qualification, the distance learning MSc/Post Graduate Diploma in Clinical Trials by Distance Learning [ 22 ] has been developed by the London School of Hygiene and Tropical Medicine and the University of London. The MSc includes project management principles as one of the fundamentals of trial conduct. Many other courses and workshops on clinical trials also include an element of project management skills training. However, although intuitively trial managers are utilising these skills, more evidence is needed to support the application of project management principles and practices to clinical trial management for future trialists.

A recurring theme in this paper is the need for those planning and doing trials to have reliable and rapid access to relevant expertise and for published standards for trial management (conduct) that avoid trialists' reinventing the wheel. Trial managers have, in recent years, begun to develop better ways of disseminating and sharing experiences and expertise. Societies and associations of trial managers in North America and Europe are beginning to network and make their knowledge available via the Internet and through journal publications. The acknowledgment by the UK Medical Research Council in setting up the UK Trial Managers' Network in 1998 highlighted the need to share expertise in this field and to bring together trial managers who have no professional forum in which to network. Experienced trialists will have put together, either formally or informally, plans and checklists of essential steps in the development of a trial on the basis of their experience of what does or does not work. Those planning their first trial often have to start from scratch unless they are lucky enough to have access to a clinical trials unit or someone with relevant experience. Many trials struggle to finish, or even to get underway, because the people running them have not been able to find information about the best processes for establishing and delivering a trial. There is a need for appropriate training which is easily accessible, but the real problem is the lack of a standard method which will ensure high-quality trial management. Having such a standard would ensure that both funders and trial managers maximise the trial investment and the chances of success. Much of trial management is intuitive utilisation of skills gained in other areas of work or on the basis of experience and as such could not be the subject of robust research methodologies. Robust, meaningful and enforceable standards for the management of trials would require effort on behalf of a collaborative group (using trial management principles), including funders, investigators, trial managers and other interested groups and would take time but would do much to move the issue forward. If such a standard could be agreed on, this would more accurately identify training requirements and open the door to more appropriate research into what is undoubtedly a vital component in successfully completing a clinical trial.

The very important and internationally accepted CONSORT Guidelines were developed because there was a will to improve the way important research was published. There is the same will amongst trialists to improve trial management methods and provide sound published evidence to be used to successfully evaluate important health research. We urge that funders, trialists, trial managers and all interested groups come together, led by opinion leaders in the field, to discuss and debate trial management methods with the aim of providing a standard for trial management and a guideline for those running clinical trials to work toward. We also suggest that the editors of medical journals might want to consider the importance of how good research is actually carried out and require that trial management methods be part of articles considered for publication. If trial management continues to be unrecognised through a lack of standard methodology and training, it will be to the detriment of future research and health care.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

All authors contributed to the development and production of the manuscript. All authors read and approved the final manuscript.

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Open Access

Ten simple rules for successfully carrying out funded research projects

* E-mail: [email protected]

Affiliation School of Heath and Sport Sciences, Fundación Universitaria del Área Andina, Bogotá, Colombia

Affiliation Vicerrectorado de Investigación, Universidad Continental, Lima, Peru

Affiliations Clinical Research Centre, The First Affiliated Hospital of Shantou University Medical College, Shantou, China, School of Public Health, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, Shandong, China, Beijing Key Laboratory of Clinical Epidemiology, Capital Medical University, Beijing, China, Centre for Precision Health, Edith Cowan University, Perth, Australia

• Diego A. Forero, 
• Walter H. Curioso, 

Published: September 19, 2024

• https://doi.org/10.1371/journal.pcbi.1012431
• Reader Comments

Citation: Forero DA, Curioso WH, Wang W (2024) Ten simple rules for successfully carrying out funded research projects. PLoS Comput Biol 20(9): e1012431. https://doi.org/10.1371/journal.pcbi.1012431

Editor: Russell Schwartz, Carnegie Mellon University, UNITED STATES OF AMERICA

Copyright: © 2024 Forero et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The authors received no specific funding for this work.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Receiving research funding, from external or internal sources, is one of the most important and challenging tasks for investigators around the world [ 1 , 2 ]. There are many prestigious research funding organizations, such as the National Institutes of Health of the US (NIH), the National Health Service of the UK (NHS), the National Science Foundation of the US (NSF), the European Commission (EC), the National Natural Science Foundation of China (NSFC), and the Japan Society for the Promotion of Science (JSPS), among many others. Although several scientific articles have provided important advice on how to write adequate research proposals and how to present them to be funded [ 3 – 5 ], how to become a principal investigator [ 6 ], and/or how to establish a laboratory [ 7 ], there is still a scarcity of articles addressing how to carry out research projects successfully and in an ethical way after the proposal has been granted.

Obtaining funding is usually the beginning of the research cycle [ 2 ] and an adequate implementation of the scientific activities, as proposed in the grant application, is of paramount importance for the generation of new knowledge, the preservation of scientific collaborations, and the academic advancement of the researchers [ 1 ].

In these Ten Simple Rules, we provide valuable recommendations for successfully carrying out funded research projects, from our perspective and experience as both researchers and peer reviewers. These Ten Simple Rules are focused on activities carried out after a grant is awarded and they will be particularly useful for junior researchers globally. Regarding the presentation order of these Ten Simple Rules, some of them involve activities that are sequential (such as Rules 5, 6, and 9) and others comprise actions in parallel (such as Rules 3, 4, and 7). A graphical overview of the proposed Ten Simple Rules is presented in Fig 1 .

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https://doi.org/10.1371/journal.pcbi.1012431.g001

Rule 1: Focus the efforts on achieving the goals and deliverables of the project

Usually, funding bodies generate a contract, or a similar document, with the defined deliverables of the research project, such as peer-reviewed publications, presentations, patent applications, training of students, and public outreach activities, among others. In many cases, the contract is sent to administrative offices in the institution of the principal investigator and, depending on the funder, the expected deliverables are previously defined in the call for applications. The contract, or a similar document, will be a key guide from the start of the project, as the timeline, and budget, of a proposal is focused on the generation of those deliverables and the achievement of the proposed research goals; considering those deliverables from an early stage of the project will be important for an adequate and successful execution. Commonly, the timeline of a research project is presented in a Gantt chart, describing the main activities and the corresponding months or weeks projected for their execution [ 8 ].

Rule 2: Define and assign responsibilities and roles of the research team members

Commonly, the grant application involves researchers with specific roles, such as the Principal Investigator (PI, the person leading the project) and the coinvestigators, who are proposed as responsible for certain activities, such as evaluation of patients or animals or statistical analysis of data, based on their academic profiles and research experience. In large projects, there is a possibility of hiring a Project Manager (PM), who is responsible for coordinating multiple scientific and administrative tasks [ 9 ]. Each member of a research team should have clear responsibilities, in order to complete the expected tasks in the predefined timeline and to avoid conflicts between them; it is of particular relevance for multicenter studies or for projects with challenging topics or methods. Other roles involve external advisors, administrative staff or students, each with a specific participation in the research project. It is advisable to plan for contingencies related to team members, such as having standard procedures for handling transitions associated with the arrival or departure of staff. Details of authorship should be reviewed in advance, following international recommendations and taking into account the main principles of research integrity [ 10 ].

Rule 3: Schedule regular meetings among the research team members

Adequate communication among members of a research team, and between sub teams, is a key aspect in a research project. Regular meetings facilitate the periodic presentation of advances, in addition to providing a platform for discussion and documentation of findings and of potential challenges. In addition, consultations with administrative personnel from institutional offices (such as those related to budget or research oversight) are also important. Meetings should have a well-structured agenda about key issues and their frequency should be balanced, in order to avoid having too many sessions and wasting the valuable time of researchers.

An early identification and management of issues, such as difficult situations in communication between the research team or failures in experiments, may avoid occurrence of larger problems in the future. In the context of multi-institutional and international collaborations (which have particular challenges in terms of needing further definitions of roles and responsibilities), online systems for videoconferencing are time efficient and cost effective approaches for project meetings, in addition to in-person meetings [ 11 ]. Other online resources and technological tools for project management and collaboration, such as instant messaging applications, could contribute to the generation of knowledge and facilitate communication between research team members and collaborators [ 12 ].

Rule 4: Comply with regulatory, ethical, and research integrity guidelines

A research team should have a strong commitment to comply with scientific integrity principles and best practices [ 13 ], highlighting the requirement for establishing internal strategies that promote the continuous adherence to national and local ethical regulations, such as guaranteeing the confidentiality of clinical data from participants [ 14 ]. In an era of electronic publication and social media [ 15 ], failures of scientific integrity or occurrence of research misconduct are even more visible.

In this context, in addition to international guidelines, countries have different types of laws and local regulations related to ethical and research integrity aspects, which should be actively taken into account by the research team. In terms of research involving human subjects, 2 main aspects emerge: approval by an institutional research ethics committee, which is commonly required by funders before the start of the project, and the signing of informed consent forms by participants [ 16 ], a process that should be carefully monitored. Regarding research with animal models, approval by an institutional animal ethics committee is commonly required [ 17 ]. In addition, other legal and administrative permissions, such as those from external or public institutions, might be needed in certain cases.

A Scientific Integrity Consortium, composed by representatives from 27 institutions from the United States and Canada, has developed a set of 9 core principles and best practices for scientific integrity that every researcher should comply with [ 18 ]. Some of these principles, of interest for teams carrying out research projects, are requiring universal training on responsible research practices, encouraging reproducibility of research and strengthening scientific integrity oversight [ 18 ].

Rule 5: Follow predefined data analysis plans

An adequate application of key statistical concepts, such as the calculation of sample sizes, is important not only for the analysis of results, but also for design and execution of research projects [ 19 , 20 ]. In this context, data analysis plans are common key components of grant applications, predefining aspects such as definitions of groups, key variables to be analyzed, and statistical tests to be used [ 21 ]. Many funders require data management plans and a previous Ten Simple Rules paper gave advice about its creation [ 22 ]. Following those predefined plans would facilitate an adequate analysis of data [ 23 ], avoiding “p-hacking” [ 24 ], among other inadequate practices. In multiple research areas, there has been a growth in carrying out preregistration of studies [ 25 , 26 ] and recently Lakens has provided recommendations about when and how to deviate from preregistrations [ 27 ]. In the era of Open Science, a research team must be aware that scientific journals may require them to share their data plans when submitting a derived manuscript [ 28 , 29 ].

Rule 6: Use validated methods for data collection and keep backups of data and analyses

The use of well-established methods for data collection, such as the employment of previously validated psychosocial scales [ 30 ] or well-known and reliable molecular methodologies, is key for obtaining high-quality research results [ 22 ]. A periodic monitoring of data quality is beneficial for research projects [ 31 ] and there are multiple approaches for doing so (such as the use of positive and negative controls or external standards, among others), depending on the specific methods used. As an example from molecular methods [ 32 ], a positive control is a sample known to have the feature of interest (such as a target for PCR amplification) and a negative control is a sample known as not having the feature of interest.

In some cases, the project might involve the creation, adaptation, or refinement of novel methods [ 30 ], which usually requires time and resources for their comparison with previous approaches. In many cases, an initial pilot phase [ 33 ] allows the identification of minor adjustments needed for data collection on a larger scale. In multicenter projects, it is advised that all participating sites employ the same protocols.

Misplacement, accidental damage, or loss of research data, such as results from phenotypic evaluations or molecular studies, would be catastrophic for any research project. In this context, strategies such as the use of Electronic Laboratory Notebooks [ 34 , 35 ], in addition to the frequent employment of multiple backups (in the cloud and in different computers) would avoid the loss of research data [ 22 ]. Constant backup of derivative files, with evolving versions of data analyses and manuscripts, is also recommended. An adequate structure of databases [ 36 ] involves their complete annotation and facilitates future data reanalysis. Another previous Ten Simple Rules article about digital data storage [ 29 ] would be a very useful resource for researchers. In addition, Boland and colleagues wrote an interesting paper about enabling multisite collaborations through data sharing [ 37 ].

Rule 7: Implement the research budget and promote adequate administrative management

Although there are differences between calls for applications and between funders, there are 2 main types of costs, direct and indirect. Direct costs are related to the specific needs of the project and commonly include categories such as personnel, consultations and subcontracts, equipment, supplies, and travel, among others [ 12 , 38 ]. On the other hand, indirect costs are funds to cover the research infrastructure of the institution [ 39 ].

Commonly, costs associated with personnel are some of the largest in a research budget and there are previous suggestions regarding the adequate selection, recruiting, hiring, and management of scientific personnel [ 9 ].

There are some previous recommendations regarding the implementation of the research budget, such as the need for its revisions after the notice of award, the importance of including projections of inflation in multiyear grants and taking into account the possibility of having increased costs for certain categories [ 40 ]. Of particular interest for certain world regions, such as the Global South, there is the common need of considering the increased costs and times related to importing certain equipment and reagents from abroad. In terms of project management, which involves multiple administrative aspects, certain aspects are key, such as the need for strategic planning, adequate communication, and frequent monitoring, among others [ 8 ]. Additional elements to take into account are the constant need for training on budget management for the PIs, the adequate communication between the PI and the Project Manager, and having frequent administrative support from the institution [ 38 ].

Rule 8: Assign enough time for reports

Final, and partial or progress, reports are major deliverables from research projects and their elaboration commonly involves a large amount of time and dedication. Partial or progress reports are quite useful for evaluating the performance of project activities in previous periods and adequately planning experiments and analyses for upcoming periods.

Final reports include a description and discussion of the results obtained and the perspectives for future studies, in addition to budget reports and generated deliverables. In many cases, it involves weeks of work and the participation of several researchers and support staff. Although its writing would need the involvement of all team members, the coordination of its elaboration is commonly a major responsibility of the PI (in close collaboration with the PM, when possible). As previously discussed, an adequate documentation of research procedures and findings would diminish the possibility that the departure of team members, among other unexpected events, negatively affect the elaboration of the research reports.

Rule 9: Publish the findings and share the results of your project

Publication in peer-reviewed scientific journals remains one of the main forms to communicate research findings [ 41 ]. Publishing your positive or negative results, avoiding an overinterpretation of actual research findings [ 42 ], facilitates that the international scientific community receives and discusses the results and conclusions from your project [ 43 ]. In addition to original articles, which are the primary form of publication for new research results, consider other types of articles such as reviews, viewpoints, perspectives, and special articles to disseminate your insights about a research topic. A recent Ten Simple Rules paper provided suggestions for writing Registered Reports [ 44 ], which are a type of research publication where the proposed methodology is peer reviewed prior to data collection, to avoid publication and reporting biases. It involves 2 stages: Stage 1, where the introduction and proposed methods and analysis plans are reviewed, and Stage 2, where the results and discussion are included and reviewed [ 44 ].

Following international standards for the reporting of studies, such as those from the EQUATOR Network [ 45 ], promotes an adequate presentation of research findings. From an Open Science perspective, deposition of open research data in public repositories promotes transparency of results [ 46 , 47 ] and facilitates replications of results and secondary analyses [ 48 ]. In this context, the FAIR Guiding Principles are important and involve the following aspects: being Findable, Accessible, Interoperable, and Reusable [ 49 ]. Many funding organizations have policies with specific requests about research data sharing and some examples of these policies can be found at: https://sharing.nih.gov/data-management-and-sharing-policy (for the NIH, USA) and https://wellcome.org/grant-funding/guidance/data-software-materials-management-and-sharing-policy (for the Wellcome Trust, UK).

Rule 10: Share your results with the general public

Public outreach is another major aspect of scientific research [ 50 ], particularly because scientific projects are commonly taxpayer-funded, among others. In this regard, appropriate communication of research results to the public is of paramount importance, which involves strategies such as talks or texts oriented for the communities, using an easily understandable language [ 51 ] and avoiding exaggeration or misrepresentation of the actual research findings [ 52 ]. In addition, communication of research results at national and international conferences [ 53 ], and to other major stakeholders, such as professional societies or associations of patients, is also recommended. Social media, infographics, and podcasts are evolving as useful tools for the dissemination of new scholarly material and resources [ 53 ]. Consequently, it is becoming increasingly important for research teams to undergo training in the effective dissemination and knowledge translation of their work [ 54 ].

Future considerations

Several of the Ten Simple Rules presented here are not exclusive to the process of carrying out funded research projects, as they are also necessary for other related scientific processes, such as the writing of grant applications or manuscripts. Scientific research is in constant evolution, and it is possible that in the near future, the execution of research projects also changes, taking into account aspects such as the increase of international mega-collaborations [ 55 ], the growth in the use of automated and high-throughput tools, including recent tools from generative artificial intelligence, and the constant need to verifying the integrity and quality of research findings [ 39 ], among others. Of particular importance, researchers should always carry out research projects with the highest standards of ethics and research integrity [ 56 ], avoiding negative practices, such as “Helicopter Research” [ 57 ], or gift or ghost authorship [ 10 ]. For the individual research teams, each new project is an opportunity to learn from both failures and successes, in order to refine and improve management strategies for future research initiatives. Finally, research institutions and groups should consider the need for frequent training activities related to multiple aspects of the execution of scientific projects [ 38 ].

Acknowledgments

The authors thank Leon Ruiter-Lopez (University of Pittsburgh, USA) for his help with a revision of the manuscript.

• View Article
• PubMed/NCBI
• Google Scholar
• 52. König LM, Altenmüller MS, Fick J, Crusius J, Genschow O, Sauerland M. How to communicate science to the public? Recommendations for effective written communication derived from a systematic review. Preprint, PsyArXiv 2023.

The Ultimate Guide to Clinical Research Management Software

Clinical research management software plays a crucial role in streamlining and optimizing the operations of clinical trials. This comprehensive guide will walk you through everything you need to know about this essential tool and how it can benefit your organization. From understanding the basics to selecting the right software and implementing it effectively, we will cover all aspects to ensure you make informed decisions for your clinical research management needs.

Understanding Clinical Research Management Software

In order to fully grasp the benefits and functionalities of clinical research management software , it is important to have a clear understanding of what it entails. Clinical research management software refers to specialized software solutions that are designed to assist clinical trial teams in efficiently managing all aspects of their research projects.

These software tools enable organizations to centralize and automate various tasks such as data management, regulatory compliance, and patient recruitment and retention . By streamlining these processes, clinical research management software enhances productivity and efficiency, ultimately leading to more successful and cost-effective clinical trials.

Defining Clinical Research Management Software

Clinical research management software is a powerful tool that enables organizations to keep track of crucial data related to their clinical trials. It acts as a central repository for all study-related information, allowing researchers to manage, analyze, and report on data easily and accurately.

Furthermore, clinical research management software often includes features such as project management tools, document management capabilities, and collaboration features, which facilitate effective communication and collaboration among the various stakeholders involved in a clinical trial.

Importance of Clinical Research Management Software

The importance of clinical research management software cannot be overstated. By providing a centralized and comprehensive platform for managing clinical trial operations , this software significantly reduces the administrative burden on research teams. With the increasing complexity of clinical trials and the growing regulatory requirements, manual record-keeping and outdated paper-based processes are no longer sufficient. Clinical research management software ensures accurate record-keeping, enhances data integrity, and simplifies compliance with regulatory guidelines.

Additionally, this software enables organizations to improve patient recruitment and retention by leveraging advanced features such as patient databases, electronic medical record integration, and automated communication tools. In the ever-evolving and highly regulated field of clinical research, adapting to new technologies is essential for staying ahead. Clinical research management software has emerged as a crucial tool for organizations seeking to optimize their operations and achieve successful outcomes.

Moreover, clinical research management software offers a range of benefits beyond just data management and regulatory compliance. It can also help streamline financial management by providing tools for budgeting, invoicing, and tracking expenses related to clinical trials.

Furthermore, this software often includes reporting and analytics capabilities, allowing researchers to generate comprehensive reports and gain valuable insights from their data. These insights can inform decision-making, drive process improvements, and contribute to the overall success of clinical trials.

Another important aspect of clinical research management software is its ability to enhance collaboration and communication among research teams. With features such as real-time messaging, task assignments, and document sharing, researchers can easily collaborate on study protocols, data analysis, and other critical aspects of their research.

Furthermore, some clinical research management software solutions offer integration with electronic health record systems, enabling seamless exchange of patient data and facilitating efficient data collection and analysis.

In conclusion, clinical research management software is a powerful tool that offers numerous benefits to organizations involved in clinical trials. From streamlining administrative tasks and ensuring regulatory compliance to improving patient recruitment and retention, this software plays a crucial role in optimizing clinical trial operations and achieving successful outcomes.

Key Features of Clinical Research Management Software

When evaluating different clinical research management software options, it is important to consider the key features that are essential for your organization's specific needs and requirements.

Data Management Capabilities

A robust clinical research management software should provide advanced data management capabilities . This includes the ability to collect, store, and analyze data securely and efficiently. Look for features such as data encryption, data validation checks, and customizable data entry screens.

Additionally, it is crucial to have a software that offers comprehensive data tracking and reporting functionalities. This allows researchers to easily monitor and analyze the progress of their clinical trials, identify any potential issues, and make informed decisions based on the data collected.

Regulatory Compliance Tools

Compliance with regulatory guidelines is a critical aspect of running successful clinical trials. Clinical research management software should offer built-in regulatory compliance tools, such as integrated IRB management, electronic signatures, and audit log functionalities, to ensure adherence to established protocols.

Moreover, it is essential to have a software that enables seamless collaboration and communication among all stakeholders involved in the clinical trial process. This includes researchers, sponsors, regulatory authorities, and ethics committees. By providing a centralized platform for document sharing, real-time updates, and secure messaging, the software can streamline the regulatory compliance process and facilitate efficient decision-making.

Furthermore, software that allows tracking and reporting of adverse events and serious adverse events (SAEs) can greatly simplify the reporting process and improve safety monitoring. This feature ensures that any potential risks or complications associated with the trial are promptly identified and addressed, enhancing the overall safety and well-being of the participants.

Patient Recruitment and Retention Features

Efficient patient recruitment and retention are paramount to the success of clinical trials. Look for software that provides features such as patient database management, automated patient communication, and electronic consent forms.

Moreover, partnering with a contract research organization ( CRO ) that specializes in patient recruitment and retention can significantly enhance the effectiveness of your clinical research management software. With their expertise, they can help organizations maximize participant enrollment and engagement in clinical trials, ultimately improving trial success rates.

In conclusion, when choosing clinical research management software, it is crucial to consider the key features that align with your organization's specific needs. From robust data management capabilities and regulatory compliance tools to patient recruitment and retention features, selecting the right software can greatly enhance the efficiency, accuracy, and success of your clinical trials.

Selecting the Right Clinical Research Management Software

Choosing the right clinical research management software is a crucial decision that can impact the efficiency and success of your clinical trials. Here are some important factors to consider when evaluating different software options.

Evaluating Your Organizational Needs

Before beginning your search for clinical research management software, thoroughly evaluate your organization's specific needs and challenges. Consider factors such as the size of your organization, the number of ongoing trials, and the specific functionalities required to support your research operations.

Comparing Different Software Options

Once you have identified your organization's needs, carefully compare different software options available in the market. Look for user-friendly interfaces, comprehensive features, and strong customer support services.

Lindus Health's clinical research management software offers a user-friendly interface, intuitive navigation, and robust features that cater specifically to the needs of clinical trials. With their extensive experience in the field, Lindus Health understands the challenges faced by research organizations and has developed a software solution that addresses these challenges effectively.

Considering Budget and ROI

Budget considerations are an important aspect of any software selection process. While it is crucial to find a solution that fits within your budget constraints, it is equally important to consider the return on investment (ROI) that the software can provide.

Investing in a high-quality clinical research management software can yield significant long-term benefits, including increased operational efficiency, improved data quality, and enhanced patient recruitment and retention rates.

Implementing Clinical Research Management Software

Once you have selected the right clinical research management software, it is important to ensure a smooth and successful implementation process. Here are some key factors to consider.

Training and Support for Users

Providing adequate training and support for users is crucial to the successful implementation of clinical research management software. Ensure that your software provider offers comprehensive training programs and ongoing support services to help your team make the most of the software's features.

Integration with Existing Systems

Effective integration of clinical research management software with existing systems is essential for seamless data transfer and optimal functionality. Work closely with your software provider to ensure smooth integration with other tools or systems already in use within your organization.

Ongoing Software Maintenance and Updates

Regular maintenance and updates are crucial to keep your clinical research management software up-to-date and functioning optimally. Choose a software provider that offers regular updates, bug fixes, and customer support to ensure that your software remains current and reliable.

Clinical research management software is a powerful tool that can revolutionize the way clinical trials are conducted. Its numerous benefits, including enhanced efficiency, improved data management, and streamlined patient recruitment, make it a must-have for any organization involved in clinical research.When selecting clinical research management software, carefully consider your organization's needs and evaluate the available options. Remember to prioritize user-friendliness, functionality, and support services provided by the software provider. Lindus Health , as a leading CRO, understands the unique challenges faced by research organizations and offers a comprehensive software solution that caters specifically to the needs of clinical trials. By implementing the right clinical research management software and leveraging the expertise of Lindus Health, organizations can significantly enhance the efficiency and success of their clinical trials, ultimately advancing medical research and improving patient care.

Ready to elevate your clinical trial management to new heights? Partner with Lindus Health and experience the seamless integration of full-stack CRO services and our all-in-one eClinical platform. From protocol writing to data delivery, we provide the comprehensive support your study needs. Book a meeting with our team today and discover how we can streamline your clinical research for better efficiency and success.

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