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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

Fantastic resources

I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

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Useful Resources

Project Plan Template for Clinical Research

Great for beginners
Ready-to-use, fully customizable Subcategory
Get started in seconds

Organize and track project tasks
Break down projects into manageable goals and tasks
Communicate progress to all stakeholders involved

Benefits of a Clinical Research Project Plan Template

Develop an overall timeline for the project
Specify milestones and corresponding deadlines
Recognize any special considerations or constraints related to the project
Identify resources required for the project

Main Elements of a Project Plan Template for Clinical Research

Who will be responsible for each phase of the project?
What resources will be needed in each phase?
When will each phase start and end?
Who will be responsible for budgeting and controlling costs?
How will data collection be performed?

How to Use a Clinical Research Project Plan Template

1. identify the objective., 2. outline scope and methodology., 3. develop criteria for success., 4. assign resources and roles., 5. develop risk management strategies., 6. monitor progress., related project plan templates.

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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!

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 Deviation Tracking Log 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.

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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.

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Site Selection Visit Form Template

Pre Site Selection Visit Checklist Report 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.

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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.

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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.

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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.

Clinical Trial Timeline and Graph Template

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.

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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.

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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

Data and Safety Monitoring Plan Template for Clinical Research

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.

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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.

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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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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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What to know about project management for clinical trials.

A person sitting at a desk works on clinical trial project management

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 patient recruitment template

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Introduction to Clinical Research Project Management

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

In this article, we will provide a comprehensive introduction to clinical research project management, exploring why project management is essential for the successful execution of clinical trials.

Introduction to Clinical Research Project Management : Group of individuals looking at a white board with project timelines and graphs being presented by a project manager.

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.

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 in a timely manner.

Resource Optimization

Clinical research projects require various resources, including personnel, funding, equipment, and facilities. Project managers play a vital role in resource management, ensuring that resources are allocated efficiently and utilized optimally. They identify resource requirements, secure 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 that can impact 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.

Research Project Plan Template

What is a Research Project Plan?

A research project plan outlines the processes and activities that need to be completed to achieve the desired results of a research project. The plan should provide a timeline for the research activities and identify any potential risks. It should also specify the resources and personnel needed, as well as the budget and timeline for the project. The plan should be both comprehensive and flexible, so that it can be modified as needed throughout the project.

What's included in this Research Project 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 Research Project Plan template for?

The research project plan template is designed for research teams in academic, corporate, or non-profit sectors who need to plan and execute their research projects. The template provides a structure for outlining the processes and activities that must be completed in order to achieve the desired results of the research project. The template is designed to be comprehensive and flexible, allowing for modifications as needed throughout the project.

1. Define clear examples of your focus areas

A focus area is a specific area or topic that a research team is investigating. The focus area should be clearly defined and specific, so that the research team can develop objectives, projects, and KPIs that are relevant to the research project. Examples of focus areas could include developing new technologies, understanding customer behavior, or studying the effects of a particular policy.

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

Objectives are the goals that a research team hopes to achieve by completing the research project. Objectives should be specific and measurable, and should be attainable within the timeline and budget of the research project. Examples of objectives could include developing a new technology, understanding customer behaviors, or studying the effects of a particular policy.

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

Key Performance Indicators (KPIs) are measurable targets that are used to evaluate the progress of a research project. KPIs should be specific and measurable, and should be established in order to track progress towards the objectives of the research project. Examples of KPIs could include product development timelines, customer satisfaction surveys, or policy implementation reviews.

4. Implement related projects to achieve the KPIs

Projects are the activities that need to be completed in order to achieve the objectives of the research project. Projects should be specific and achievable, and should be completed within the timeline and budget of the research project. Examples of projects could include running customer surveys, conducting interviews, or collecting data.

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

The Cascade Strategy Execution Platform is a comprehensive software that helps research teams plan, manage, and track their research projects. The platform provides tools for project management, tracking KPIs, and monitoring progress. It also helps teams visualize their data and collaborate on initiatives. With Cascade, teams can save time and resources, and get faster results from their strategies.

10+ SAMPLE Clinical Research Project Plan in PDF | MS Word

Clinical Research Project Plan | MS Word

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Forms, Tools, & Templates Description Category(ies) Keyword(s)
02.04.02 Investigator's Brochure Addendum Log Track versions of the Investigator’s Brochure Trial Documents TrialDocuments
01.01.01 Work Instructions TMF - PennBox Instructions explaining training requirements, user roles, access, and use of the TMF in the Veeva Vault system Trial Master File TrialMasterFile Penn Box
01.01.01 Work Instructions TMF - Veeva Instructions explaining training requirements, user roles, access, and use of the TMF in the PennBox system. Trial Master File TrialMasterFile Veeva
01.02.03 Notice of Disclosure of FCOI Template for written disclosure of FCOI IND; IDE; Sponsor INDIDESponsor
01.02.03 Statement of Financial Interest - Sponsor Team Member Form to be used by Penn Faculty or staff of the Sponsor team to state presence/absence of financial interests for a particular study. Sponsor Sponsor
01.03.01 DSMB Charter Used to clearly describe how the DSMB will function, including frequency of meetings, data to be reviewed, how safety items will be communicated, etc. DSMB DSMB
01.03.02 DSMB Contact List Used to compile contact information for the DSMB members and their administrative support staff. May be useful as a reference during trial progress. DSMB DSMB
01.03.03 DSMB Meeting Minutes Used to document discussions during DSMB meetings. Includes documentation of attendance and disclosure of financial conflicts. DSMB DSMB
01.03.03 DSMB Outcome Email Letter Used to document the outcome of the DSMB meeting to provide to the PI(s). The PI may need this confirmation to provide to their IRB or other local regulatory review committee. DSMB DSMB
01.03.03_DSMB_Report Used to provide a summary of trial data to the DSMB. Specific section will differ by study, may be revised based on DSMB request. DSMB DSMB
01.03.05 DSMB Qualification Form Used to document potential DSMB member's agreement to serve as part of the DSMB. Includes description of confidentiality and disclosure of financial conflict of interest provisions. DSMB DSMB
01.05.01 Correspondence Log Template Log for documenting correspondence including the date, time, participants, and summary of discussion Project Management ProjectManagement
02.01.01 Investigator Brochure Template Guide for developing an Investigator's Brochure Trial Documents TrialDocuments Trial Document; Investigator; brochure
03.01.01 Expanded Access eIND Instructions for submitting an emergency IND request IND IND
03.01.01 Expanded Access sIND Instructions for submitting a (compassionate use) single patient IND request IND IND
03.01.01 IND Application Template Template for an application to the FDA for an Investigational New Drug (IND) IND; IDE; Sponsor INDIDESponsor IND, Sponsor, FDA
03.01.01 Submitting to the FDA This document describes the different way a submission can be sent to the FDA. It applies to clinical research (IND/IDE) and also to Expanded Access of drugs and devices. Sponsor Sponsor
03.03.02 IDE Progress Report Template Template for completing an IDE Progress Report IDE IDE
03.03.02 IND Annual Report Template Template for completing an IND Annual Report IND IND Investigator Annual Report
03.03.03 Closing an IND Guide to Sponsor How to discontinue an IND with the FDA. Definitions of the various IND statuses are included below for reference purposes. IND IND IND, Sponsor, FDA
03.04.01 Regulatory History Log Template for tracking all regulatory submissions of an IND/IDE IND; IDE; Sponsor INDIDESponsor
05.02.02 PI Signature Page The document to be signed by the Principal Investigator of a study at each revision of the study's protocol. Protocol Templates ProtocolTemplates
05.02.07 PI Qualification Form Template for documenting the qualifications of a Principal Investigator Sponsor Sponsor
05.02.10 Site FCOI This work instruction assists the Regulatory Specialists with understanding what documentation is required to ensure the qualification of the sponsor team members and individuals acting as vendors and to determine how qualifications should be filed in the Trial Master File (TMF).The sponsor must ensure qualification of its team members and vendors. IND; IDE INDIDE
05.02.19 IDE Investigator Agreements The investigator agreement of compliance to all requirements of the investigational plan, IDE regulations, and other applicable regulations of the FDA for investigational devices. IDE IDE Statement,Investigator
07.01.01 Work Instructions - Pharmacovigilance Work instructions on sponsor pharmacovigilance (safety) management. This includes a discussion of the sponsor responsibilities related to pharmacovigilance, as well as instructions on conducting the activities, and additional reference resources. Sponsor Sponsor
07.02.02 SAE Form Form used to document an SAE that occurs in a trial and to report the relevant information to the sponsor. Trial Documents TrialDocuments
09.01.01 GLP Qualification Guide Guide to ensuring vendors providing investigational product are qualified and follow Good Laboratory Practices Third Party/ Vendors ThirdPartyVendors
09.01.01 Manufacturing Evaluation The form to be used by Sponsors to conduct an initial manufacturing evaluation of quality for manufacturers. Third Party/ Vendors ThirdPartyVendors
09.02.03 Transfer of Obligations Guide to transferring IND/IDE sponsor obligations to another party IND; IDE INDIDE
21 CFR Part 11 for EMR Memo- Penn Medicine Electronic Health Records in Support of Clinical Research Communication; Study Start-Up CommunicationStudyStartUp part 11, 21 cfr part 11, EMR, compliance, pennchart
CLIA, CAP, Lab References and Lab Director’s CV_HUP CLIA, CAP, Lab References and Lab Director’s CV. Documents obtained annually and posted with permission from Dept. of Pathology and Laboratory Medicine, Penn Medicine-HUP Regulatory File/ Investigator Site File; Source Documentation RegulatoryFileInvestigatorSiteFileSourceDocumentation CLIA, CAP, Lab References
CLIA, CAP, Lab References and Lab Director’s CV_PRESBY CLIA, CAP, Lab References and Lab Director’s CV. Documents obtained annually and posted with permission from Dept. of Pathology and Laboratory Medicine, Penn Medicine-Presbyterian Regulatory File/ Investigator Site File; Source Documentation RegulatoryFileInvestigatorSiteFileSourceDocumentation CLIA, CAP, Lab References, Presby
CRF Testing Script - Blank Template CRF Testing Script - Blank Template Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crf, crms, data management
CRF Testing Tracker CRF Testing Tracker Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crf, crms, data management
CRF build and Schedule of Events tracker CRF build and Schedule of Events tracker Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crf, crms, data management
CRSPR Email Listserve Clinical Research Staff Portal and Registry (CRSPR) is an email listserve to communicate important, timely information to Penn Medicine's Clinical Research Professionals. Needs PennKey login. Sign up by creating a profile, to receive emails from OCR, IRB, CHPS, etc. OCR Applications OCRApplications CRSPR, listserve, application, email, portal, registry
Case Report Form Amendments Log Track Case Report Form (CRF) versions and changes Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile CRF
Clinical Research Resource Feasibility Assessment Budget/ Finance BudgetFinance
Clinical Trial Protocol Template This protocol template is designed to help research teams develop a clinical trial protocol that includes an investigational intervention (drug, biologic, vaccine or device). Protocol Templates ProtocolTemplates
Close Out Visit Checklist - Investigator Checklist for closing out a protocol Monitoring Monitoring
Close Out Visit Checklist- Sponsor Investigator Checklist for closing out a protocol by a Sponsor or Sponsor Investigator Monitoring Monitoring
Closing IDE Guide to Sponsor How to discontinue an IDE with the FDA. Definitions of the various IDE statuses are included below for reference purposes. IDE IDE
Cost Finder Tool with research rates for both Hospital Billing (HB) and Professional Billing (PB), components of an item/service/procedure. Select at least one entity (HUP, PPMC, PAH OR CCH) prior to searching.Pricing may vary by entity. Ability to search by CPT code (preferred) or procedure name. OCR Applications; Study Start-Up OCRApplicationsStudyStartUp Cost Finder, finance, start up
Data Safety Monitoring Plan (DSMP) With Guidance This template is intended to be used to develop a data safety monitoring plan. Monitoring Monitoring DSMP, monitoring, Data Safety Monitoring Plan
Database Activation Authorization Database Activation Authorization Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crf, crms, data management
Database Lockdown Checklist and CRMS Examples Database Lockdown Checklist and CRMS Examples Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crms, source
Delegation of Responsibility and Signature Log Document study personnel and their role on the study, as delegated by the Principal Investigator. Also serves as a signature log to identify signatures on research forms. Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
Device Investigational Plan Template Guide to developing an Investigational Plan for medical device research IDE IDE
Device Product Information This guidance document assists US IDE, IND, and foreign clinical research device applicant holders in determining what product information is needed and where to place device product information. IDE IDE
Electronic Data Management Tool This tool is used to assist the determination of what data management tool would be most beneficial for your research study. Budget/ Finance BudgetFinance
Electronic Database Build and Activation Summary Plan Electronic Database Build and Activation Summary Plan Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation data management , sponsor, source documentation
GLP Vendor Qualification Form Template to qualify non-clinical vendors Third Party/ Vendors ThirdPartyVendors
Good Laboratory Practice (GLP) Qualification Guide Guide to ensuring vendors providing investigational product are qualified and follow Good Laboratory Practices IND; IDE; Sponsor INDIDESponsor Third Party/Vendors; Sponsor; Investigational Product
ICH GCP Essential Documents Table of regulatory files that should be maintained by the PI and Sponsor throughout a clinical research study Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
IND Enabling Nonclinical Safety Study Work Instructions These work instructions are intended as guidance for personnel who (i) conduct or assist in the conduct of Nonclinical Safety Studies (NSS) to be submitted in support of an IND Application or (ii) have oversight of such activities. Although such studies usually occur prior to the submission of an IND, these work instructions also apply to NSS performed after IND approval and in support of clinical development. If an individual is subject to a FINANCIAL CONFLICT OF INTEREST (FCOI) management plan issued by the Vice Provost for Research, the conditions of the management plan will apply to the conduct of NSS. IND IND
IND IDE Exemption Amendment Risk Assessment This form provides instructions, and may be used to document, the Sponsor Investigator’s risk assessment for minor changes to a protocol that has previously received an IND or IDE exemption determination. Protocol Templates; Sponsor ProtocolTemplatesSponsor
IND-IDE Sponsor Responsibilities Guide Responsibilities of an IND/IDE Sponsor IND; IDE INDIDE
IND-IDE Submision Planner Checklist to assist in preparing the final IND/IDE application package to be submitted to FDA. IND; IDE INDIDE
Informed Consent Form (ICF) Version Log Tracking log of approvals for Informed Consent Form Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
Investigational Device Exemption (IDE) Application Instructions Instructions for completing the application for an Investigational Device Exemption (IDE) IND; IDE; Sponsor INDIDESponsor
Investigational Device Exemption (IDE) Application Template Template for an application to the FDA for an Investigational Device Exemption IND; IDE; Sponsor INDIDESponsor
Investigational Device Exemption (IDE) Cover Letter Template Template cover letter to accompany the Investigational Device Exemption (IDE) application IND; IDE; Sponsor INDIDESponsor
Investigational Product Accountability Study Log Study-level investigational product accountability log (all subjects on one log) Sponsor Sponsor
Investigational Product Accountability Subject Log Subject specific investigational product accountability log Sponsor Sponsor
Memo from Penn IRB Memo from Penn IRB regarding the IRB not disclosing names of its members. This is a necessary component of the IDE application. IDE IDE
Monitoring Analysis Template This tool is intended to assist in the planning for monitoring a clinical trial. Monitoring Monitoring
Monitoring Assessment Guidance Document This document is designed to assist study teams with completing an appropriate monitoring summary for the Penn IRB at the time of continuing review. Monitoring Monitoring
Monitoring Close Out Visit Template Monitoring visit report template for the conduct of a close out monitoring visit at the end of a clinical trial. Monitoring; Sponsor; Trial Master File MonitoringSponsorTrialMasterFile
Monitoring Findings Template Monitoring Findings Template Monitoring Monitoring findings, monitoring, site
Monitoring Visit Report - Sponsor Summary Template for reporting monitoring findings to Sponsor Monitoring Monitoring
Monitoring Visit Tracking Log Log used to document monitoring visits over the course of a trial Monitoring Monitoring
Note to File Template To be used to create a Note to File which are written to identify a discrepancy or problem in the conduct of the clinical research study. Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
On-Site Query Report Form Worksheet for documenting the identification and resolution of queries Monitoring Monitoring
Participant Visit Schedule Tool for tracking the proposed and actual dates for subject study visits Study Start-Up StudyStartUp
PennCRMS CRF Guidelines and Tips PennCRMS CRF Guidelines and Tips Data Management; Sponsor; Source Documentation DataManagementSponsorSourceDocumentation edc, sponsor, crf, crms, data management
PennChart - Patient Registration Form EMPI If you need your patient/subject setup in PennChart within 24 hours Budget/ Finance BudgetFinance
Pre-Screen Phone Script (Incoming Call) Pre-screen phone script template for incoming calls from potential research participants IND; Recruitment; Regulatory File/ Investigator Site File INDRecruitmentRegulatoryFileInvestigatorSiteFile
Pre-Screen Phone Script (Outgoing Call) Pre-screen phone script template for outgoing calls to potential research participants Recruitment; Regulatory File/ Investigator Site File RecruitmentRegulatoryFileInvestigatorSiteFile
Principal Investigator (PI) Qualification Form Template for documenting the qualifications of a Principal Investigator Third Party/ Vendors ThirdPartyVendors PI; Qualification, principal investigator
Principal Investigator Compliance Assessment (PICA) The Principal Investigator Compliance Assessment (PICA) is a tool which can be used to monitor or assess the overall conduct of a study. This document is required for all active, high risk studies conducted at Penn. Monitoring Monitoring
Prospective Reimbursement Analysis/ Medicare Coverage Analysis - Budget Template Template for completing the prospective reimbursement analysis/ medicare coverage analysis and industry sponsored clinical research budget. Budget/ Finance; Regulatory File/ Investigator Site File BudgetFinanceRegulatoryFileInvestigatorSiteFile
Prospective Study Design with no Investigational Product (IP) Template Use this template to develop a clinical research protocol that does not involve an investigational product. E.g. Comparative effectiveness study, a cohort design, case control study, etc. Protocol Templates ProtocolTemplates
Protocol Adverse Event Log A Log for recording adverse events Regulatory File RegulatoryFile Adverse Event, Adverse, Event, Log
Protocol Amendments Log Track versions of the IRB approved Protocol Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
Protocol Deviation Log To track all protocol deviations. Regulatory File/ Investigator Site File RegulatoryFileInvestigatorSiteFile
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RBA Business Admin Approval Tipsheet Tipsheet for the RBA. Shows how to route request for RBN to your BA and OCR Finance for RBN creation Budget/ Finance; OCR Applications; Project Management; Study Start-Up BudgetFinanceOCRApplicationsProjectManagementStudyStartUp RBA, RBN, Research Billing application, Research Billing number, finance, BA
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Methodology
Open access
Published: 02 March 2023

Creating a best practice template for participant communication plans in global health clinical studies

Colleen E. Shelly ORCID: orcid.org/0000-0003-1824-9835 1 ,
Caroline Logan 2 ,
Beth Skorochod 2 ,
Alison Wiyeh 3 ,
Duduzile Ndwandwe 4 ,
Augustine Choko 5 ,
Innocent Valea 6 &
Boghuma K. Titanji 7

Trials volume 24 , Article number: 158 ( 2023 ) Cite this article

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Clinical trial participants have a right to be informed throughout the entire process of human subject research. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials.

We carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. Qualitative interviews ( n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template.

None of the 48 mined clinical trial protocols included a communication plan. Of the 48, 21% ( n = 21) protocols included communication-related language, and 10% ( n = 5) described plans to share trial results with participants.

The use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed.

Peer Review reports

Introduction

Respect for persons is the first basic ethical principle when carrying out human subject research [ 1 ]. Within this pillar of clinical research ethics, outlined by the Declaration of Helsinki, is an obligation to inform participants throughout the entire research process, including after a clinical trial ends [ 2 ]. It is critical that the information is communicated to study participants effectively, to avoid distress or confusion [ 3 ]. Effective communication and sharing of research results with participants and other stakeholders is vital to the success of a clinical trial, as it can improve recruitment and retention, build trust through transparency, foster collaboration, and reduce health disparities [ 1 , 4 ]. Moreover, research participants may feel more valued when the channels of communication remain intact before, during, and after their participation.

Increasingly, researchers are disseminating the findings of their studies through presentations at academic conferences and scientific publications. These means of dissemination tend to be better suited for other fellow researchers and less so for trial participants, who are often people from the lay public [ 3 ]. Although most research participants want to be made aware of research findings [ 5 , 6 , 7 , 8 , 9 ], few ever receive information on clinical trial findings in practice [ 9 , 10 ]. One survey reported that only a third of respondents who had previously volunteered in research reported having received research results [ 9 ]. Several factors may contribute to the lack of dissemination, including limited interest of participants, a mismatch between the selected communication style and the audience, challenges with reaching participants after a trial is completed, a lack of standardization and early prioritization of dissemination activities, sharing only “interesting” findings, or concerns over how to share “negative” results [ 1 , 10 , 11 ].

There are several ongoing efforts aimed at improving the dissemination of research findings to key stakeholders. The National Health Institute’s 2003 Data Sharing Policy requires the inclusion of a data sharing plan in research proposals over $500,000 in direct costs [ 12 ]. The Food and Drug Administration Amendments Act (FDAAA) of 2007 aimed to build on previous data sharing regulations and highlighted a requirement for the reporting of adverse events and summary results for FDA-approved products [ 13 ]. Nine years later, the Final Rule was implemented to improve effectiveness and increase compliance with reporting guidelines set forth by the FDAAA [ 14 , 15 ]. The Final Rule also required the inclusion of a full protocol and a statistical analysis plan (SAP) [ 14 , 16 ].

Along with the Final Rule, the 2016 National Institute of Health (NIH) Policy on the Dissemination of NIH-Funded Clinical Trial Information requires investigators with partial or full NIH funding to register and report summarized results of interventional clinical trials to ClinicalTrials.gov [ 12 ]. Similarly, The World Health Organization (WHO) passed a resolution in May 2022 outlining its support for measures to “facilitate the timely reporting of both positive and negative interpretable clinical trial results,” through the registration of results and publication of findings [ 17 ]. Though these regulations intend to increase reporting and public access to information, a recent study found that roughly 40% of registered trials reported results within the 1-year deadline, and only 63.8% reported results at any time. This cohort study observed no improvement in compliance from 2018 to 2019 [ 15 ]. The WHO reported in 2017 that less than half of clinical trials publicly report results, often due to null or negative findings [ 18 ]. Unlike requirements to ensure the reporting of data sharing plans, registration of trials, and publication of results, there are currently no requirements with regard to communication between investigators, study participants, and their communities [ 12 ]. Standardizing the participant communication process could be helpful in increasing compliance.

When developing a communication strategy, researchers should also consider how participants and communities may share the benefits of clinical research activities by asking members of the community what benefits they would find most impactful. Benefit sharing is part of a broader concept of increasing transparency and building trust in the research process. Providing a framework for benefit sharing as a required component of a communication plan serves as a tangible action to improve equity and build trust in the broader research process [ 19 ].

The aim of this study was to use qualitative and quantitative methods to (1) understand the current climate of communication language and communication plans in global health clinical trials in low-and-middle-income countries (LMICs) and (2) develop a communication plan template for clinical researchers to incorporate into their protocols, outlining communication strategies with all priority stakeholders throughout the entirety of a trial and defining methods of sharing clinical trial results once a trial has ended.

We carried out a three-pronged approach, consisting of (1) an assessment of recent clinical trial protocols for the incorporation of communication plans, (2) in-depth interviews with subject matter experts, and (3) a literature review of existing communication plans (Fig. 1 ).

Study schema

Protocol mining

We mined protocols sourced from the DAC Protocol Library on The Global Health Network [ 19 ] for language related to communication and communication plans. The DAC Protocol Library was utilized as a known resource already enriched with the types of protocols most relevant to the search criteria. Included protocols were full protocols published between 2015 and 2019 that had to describe a study carried out in an LMIC in the following disease areas: human immunodeficiency virus (HIV), neglected tropical diseases, tuberculosis (TB), malaria, maternal, newborn, and child health, nutrition, vaccines, enteric and diarrheal diseases, pneumonia, and polio. Protocols of study designs other than randomized control trials were excluded. Protocols were reviewed and consistently coded (yes/no) for the inclusion of any communication-related language (i.e., anything relating to communication with clinical trial participants, communities, or other stakeholders). Any information related to communication, regardless of relevance to communication plans, was objectively abstracted and further categorized into the following groups based on codes agreed upon by the study team: communication language (general), communication plan, community engagement, community advisory board, publicly available, results shared with local authorities, and results shared with participants. Data were recorded in Microsoft Excel. Descriptive statistics on the existence of, type, and frequency of communication language were carried out.

Qualitative interviews

In-depth interviews were conducted with a variety of clinical trial experts (principal investigators, nurses, clinical trial managers, etc.) from a wide array of organizations who each have experience conducting clinical trials in LMICs. An interview guide was developed based on protocol mining and desk research, with questions carefully crafted to understand (1) participants’ experiences with effective and ineffective communication practices pre-trial, during the trial, and post-trial and (2) participants’ suggestions and best practices for impactful strategies to improve communication with clinical trial participants and the broader community (see Additional file 1 ). Potential interview participants were chosen as a result of their extensive experience designing and executing multiple clinical trials in LMIC countries. During interviews with these identified individuals, several offered names of additional experts to consult given the nature of their experience and research. As a result of these recommendations, additional experts were interviewed. An introductory email was sent out to each potential participant with a brief description of the research and context surrounding the process for the creation of a useful communication template for global health clinical trials. Interviews were set up through email at the respondents’ preferred time and carried out and recorded via Zoom using an interview guide. Verbal consent was obtained prior to recording each interview, and participants were reminded that they could stop the interview at any time. In addition to the recording, notes were taken by two members of the study team for each interview and verified with the transcription to ensure accuracy and maintain rigor. Participants agreed to allow all interview data to be analyzed in aggregate. As this study was a qualitative and quantitative review of publicly available protocols and interviews with subject matter experts, we did not seek approval from an institutional review board.

Interview transcription and analysis

Interview recordings were imported into NVivo software NVivo (RRID:SCR_014802) and transcribed verbatim using the transcription function. The transcriptions were imported into Microsoft Word and content was validated by comparing the audio recordings to the transcribed output. Transcriptions were edited where necessary. Interviews were read and listened to twice for familiarization and then coded for communication content and important themes. Thematic content analysis was performed using the coded interviews and interview notes taken by members of the study team. Findings are summarized in Table 1 .

Benefit sharing

A brief, four-question survey was sent to interview participants using Google Forms, with an aim to understand the participants’ knowledge of benefit sharing and any potential experience incorporating it into clinical trials. An additional literature review was carried out to gain insight on benefit sharing in the current clinical trial context. A recognized author and thought leader on the subject, with a recently published paper on benefit sharing, was identified through the review process. The research team contacted the author, and a brief interview was carried out. Notes were taken during the interview and summarized to help inform the addition of benefit sharing language in the communication plan template.

Communication plan template

A comprehensive narrative literature review was conducted to assess additional published papers discussing communication plans in clinical trials. Citations from each reviewed paper deemed relevant were used to identify additional literature. Findings from the literature review were combined with quantitative and qualitative findings, and an initial communication plan template was developed. The first draft of the template was sent to each interviewee for feedback. A total of two reminder emails were sent, and feedback was received from five of the seven participants. The template was then circulated with members of the Bill & Melinda Gates Foundation’s DAC team for additional comments. Feedback was incorporated into a second communication template draft.

We identified and reviewed 48 full clinical trial protocols from the Global Health Network website [ 20 ]. The protocols described studies conducted in countries such as: South Africa ( n = 6), Bangladesh ( n = 5), Kenya ( n = 2), and 20 other LMIC countries (data reported in Table 2 and displayed in Fig. 2 ). Protocols described research in areas such as HIV, Malaria, TB, Filariasis, and other (data reported in Fig. 3 ). The following categories were recorded from metadata of mined protocols: communication language, communication plan, community engagement, community advisory board, publicly available, results shared with local authorities, and results shared with participants. Though 44% (21/48) of protocols included communication language, only one protocol mentioned a communication plan but did not include one in the document. Ten percent (5/48) of protocols detailed plans to share trial results with participants (Table 3 ).

Countries where research was carried out from 48 mined protocols

Disease areas of mined protocols

Out of the eleven clinical trial experts invited to participate in the interview process, seven agreed to participate, and interviews took place between December 2021 and January 2022. Each interview lasted approximately 45 min and was recorded on Zoom. Most participants had more than a decade of experience in clinical trials, including experience as clinical trial coordinators, nurses, doctors, lab supervisors, and principal investigators. All participants had experience in clinical trials in Africa, including Kenya, Uganda, Malawi, Tanzania, Cameroon, Senegal, Burkina Faso, Nigeria, Rwanda, and South Africa. Several experts had experience conducting trials globally, including in the USA and Latin America. The following codes/categories were identified through qualitative interviews carried out with experts in clinical trials: communication plan/community engagement plan, barriers and challenges, communication channels, post-trial communication, community advisory board, milestones/benchmarks, role in clinical trials, stakeholders, and trust (Table 3 ).

One participant completed the benefit sharing survey, stating that they were aware of the concept, but that it is “not really clear how benefit sharing works” within clinical trials. They commented that “community members, including stakeholders, [should] hold the research team accountable based on the benefit sharing principle… This, in turn, would [ensure] participants understand that their participation in a trial is for a greater good.”

In our literature review of benefit sharing in clinical trials, we found that benefit sharing is most often discussed in the context of human genomic information and data sharing. The concept itself was developed alongside the forming of the Nagoya Protocol, which outlines three objectives: “conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the utilization of genetic resources” [ 21 , 22 ]. Bedeker et al. defined benefit sharing as “the actions taken towards ensuring that various benefits of research are shared with a wide range of stakeholders in a way that is equitable and just.” Examples in clinical trials may include sharing financial benefits with trial participants, improving infrastructure in the communities where the research takes place, or providing opportunities for career advancement. They note that although a data sharing plan is typically required when applying for research funding or disseminating findings, benefit sharing is not [ 19 ]. In an interview with Dr. Nicki Tiffin, professor at the South African National Bioinformatics Institute and author on the same paper, she emphasized the barriers to effective benefit sharing in current research programs, including a lack of tangibility, difficulties with operationalization, and limited communication or transparency about the research process. She suggested that incorporating benefit sharing into a trial or community engagement plans can be simple and uncomplicated and noted that researchers should start by asking the participants and community what would be beneficial to them. She noted, “..[a benefit] could be as simple as buying three new refrigerators for a clinic, or [improving] a waiting room at a clinic.” For example, in a community in Botswana, the Collaborative African Genomic Network (CAfGEN) implemented a community engagement project in which they distributed print comics to explain sickle cell disease. This helped introduce children to genomics and sickle cell disease in an engaging way, while launching a career for the cartoonist in the process who benefited financially and reputationally from this work [ 23 ].

Dr. Tiffin urged researchers to “speak to people in the community where participants are recruited and ask what would be useful… don’t decide for the stakeholders”. If a team has a specific budget, provide the community with a set of options. This engagement could take the form of an open community focus group to inquire as to what kind of benefits they would like to see as a part of the trial in order to avoid making assumptions about what the community wants/needs. From the options voiced and in consultation with the research team on what is feasible, the community could vote to determine the benefits they would like to see most. Dr. Tiffin suggested that another hurdle in the process of implementing benefit sharing is that the conversation often gets stuck at the researcher level, deciding who gets credited, which universities receive funding, and who gets invited to conferences with other researchers. At a macro level, the failure to consciously share benefits of scientific progress with the general public through translation into public health and other benefits has impeded public support for evidence-based, scientific responses even while benefits have accrued to meso and macro stakeholders. Providing a framework to move beyond the researcher level and into the community stakeholder level is critical to overcome these challenges and to build trust in the research process more broadly (N. Tiffin, Personal Communication, 11 May 2022).

The final version of the Communication Plan Template can be downloaded here . This communication plan template was developed to support effective, inclusive communication to all stakeholders, including clinical trial participants and their broader community, before, during, and after a clinical trial. The results from our research and interview process revealed several key findings including:

The need for a communications plan pre-trial, during the trial, and after the trial’s conclusion.

The need to not only prioritize communications with trial participants but to ensure an effective communication strategy for the surrounding community. While all audiences are important, there is a need to prioritize engaging key influencers in the community who can amplify positive messages and communicate benefits to the community in a clear and compelling way.

The utility of utilizing a Community Advisory Board (CAB) with the caveat that developing a CAB will require an inclusive, deliberate, and thoughtful approach.

The need to work with communities to understand what is important to them in order to craft impactful key messages.

The need to understand the channels best suited to communicate with priority stakeholders; not only what they have access to, but what they prefer, depend on, and trust.

Given the learnings identified, we sought to develop a template that clearly outlines steps for effective communications pre-trial, during trial, and post-trial. Pre-trial communications steps outlined in the template include:

Understanding priority stakeholders and identifying shared benefits: The most effective communications are targeted. Targeted communications start with identifying and understanding priority stakeholders. This process in turn allows for the grouping of stakeholders into subsets that share similar characteristics or needs for information. This section outlines how to collect information to understand your priority stakeholders’ awareness, beliefs, and feelings about the issues being researched; influencers and what is most important to them; and preferred channels of communication. This section also outlines how to gather information in order to understand what kinds of benefits priority stakeholders would like to see from the trial, allowing trial teams to hone in on what is useful for the community, without making assumptions about the kinds of benefits the community is interested in receiving.

Priority stakeholder mapping: After a desk review and interactions with community stakeholders in the prior step, stakeholder mapping asks users to determine who will be the most important to prioritize for communications. This section of the template allows users to consider priority stakeholders, their contact information, who they communicate with, how this stakeholder group may benefit from the trial, and other important considerations.

Develop communication objectives and key messages: This section of the template outlines the importance of working with trial organizers to develop key messages surrounding the trial. Objectives should be designed to empower trial participants and the communities that surround them to understand the trial and its intent, building trust for clinical research and the institution or health facilities implementing the clinical research.

Crisis communication planning: While the template does not provide a comprehensive overview of crisis communication planning, it emphasizes what crisis communication planning entails, how to ensure benefit sharing is utilized for participants and the community even in times of crisis, and how to assemble a diverse communications team proactively before a crisis occurs.

Determine communication channels: Based on the review of priority stakeholder groups in prior steps, this step allows users to identify the appropriate channels best suited to deliver messages, the mix of communication channels required, and the ideal frequency of communications. It asks users to identify the channel, note which priority stakeholder group it reaches, and indicate which phase of the trial will use this channel (pre-trial, during trial, or post-trial).

Consent and expectation setting: This section notes the importance of participant consent and community assent. It asks users how they will assess informed consent and address risk perceptions with priority stakeholders.

Consider a community advisory board (CAB): This section advises that researchers utilize a community advisory board (CAB). CABs act as a consistent conduit of information both from and to the community around the trial and can be instrumental in understanding the cultural norms and social values that can influence a communication plan. Establishing a CAB is labor and time intensive. Once established, it needs to be nurtured throughout the trial. The guiding questions in this section outline important considerations for CAB development, should the trial design team choose to use a CAB.

The during trial communications section of this template includes:

Communication implementation plan: In the pre-trial communications section of the template, users are asked to identify priority stakeholders, create communication objectives, and develop key messages. Before the monitoring and evaluation phase, research teams must craft a communication implementation plan. This section of the template asks the user to outline the priority stakeholder group, key message, channel or activity, frequency, timing, and cost for each communication activity. This section also provides best practices around the use of infographics, as a sub-component of the communication implementation plan.

Monitoring and evaluation: This section of the template outlines how users will monitor the process and the quality of communications. This section of the template includes a guide for communication indicators such as retention rates. It asks users to consider how to measure the extent to which their communications are succeeding—and whether priority stakeholders are receiving and retaining key messages. In addition, it asks users to monitor whether communities are receiving the shared benefits outlined in the pre-trial communications section and, if not, how they might adjust in order for them to do so.

Common challenges and tactics to address them: While it is impossible to predict the kinds of challenges that will emerge in a clinical trial, this section outlines several potential communication issues and associated mitigation strategies drawn from our research and interview process. This section is not an exhaustive list but is intended to encourage users to be proactive, anticipating challenges and developing communications activities accordingly.

The post-trial communications section focuses on post-trial findings. This section outlines how to share trial results, informing clinical trial participants and the wider community. This section also emphasizes that post-trial communication is often the weakest part of the communication plan. As a result, deliberate communication activities are imperative to ensure that stakeholders conclude their trial experience positively, understand the results and the role they played in generating those results, and consider supporting/and or participating in clinical trials in the future.

The aims of this project were to understand the current use of communication plans in clinical trials and to develop an easy-to-use communication plan template for investigators to incorporate alongside other trial documents such as protocols and SAPs. Our quantitative findings showed a clear gap in the inclusion of communication plans in clinical trials, with no single trial contributing a communication plan with the study protocol.

Qualitative interviews revealed enthusiasm for a communication plan template, and through interviews with clinical trial experts, we identified several key themes, including comments on community engagement, common barriers and challenges, and types of communication channels that are most effective when designing and delivering messages to clinical trial participants and the broader community. Further, experts interviewed emphasized the connection between accessible and inclusive participant communication and the research team’s ability to build trust with the community, paving the way for future research trials and engagement.

Strengths and limitations

To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We conducted rigorous data mining of publicly available clinical trial protocols fitting our inclusion and exclusion criteria. This data, along with material from informative interviews with clinical trial experts, provided us with rich information and valuable suggestions for the development of the communication plan template. One limitation of this study was the lack of involvement of clinical trial participants in the design of the communication plan template. In addition, a brief survey was sent to interview participants to obtain data on their knowledge and perceptions of benefit sharing, but only one participant responded. Our sample size of publicly available clinical trial protocols was also limited. As this was the first version of the communication plan template, and because it outlines a set of minimum acceptable components, we advocate for its use and feedback for future iterations. Utilizing the communication plan template should be considered a best practice in clinical trials.

Availability of data and materials

Protocols used to mine for communication language are available here: https://dac-trials.tghn.org/resources/protocol-library/

Change history

12 march 2023.

This article has been updated to correct a missing hyperlink.

Abbreviations

Community advisory board

Food and Drug Administration Amendments Act

Human immunodeficiency virus

Low-and-middle-income countries

National Institutes of Health

Statistical analysis plan

Tuberculosis

World Health Organization

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Mamela A. Project Report: Genome Adventures: where science meets fun. The Global Health Network. 2016. https://mesh.tghn.org/articles/reflections-and-learning-genome-adventures/ .

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Acknowledgements

We would like to thank all interviewees that took the time to meet with us and help us develop this communication plan template. Without them, this project would not have been possible. We would also like to thank the Bill & Melinda Gates Foundation, specifically the DAC team and Thea Norman, for their support and guidance throughout this project.

This project was supported by the Bill & Melinda Gates Foundation (INV-036697) from project conception to manuscript development.

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HealthAnalytix, LLC, 85 Larch St., Providence, RI, USA

Colleen E. Shelly

CollaborateUp Inc, 208 Noland Street, Falls Church, VA, USA

Caroline Logan & Beth Skorochod

Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA

Alison Wiyeh

Cochrane South Africa, South African Medical Research Council, Francie Van Zilj Drive, Parow Valley, Cape Town, South Africa

Duduzile Ndwandwe

The Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso

Augustine Choko

Malawi Liverpool Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital College of Medicine, Blantyre 3, Malawi, C, P.O. Box 30096, Chichiri, South Africa

Innocent Valea

Emory University School of Medicine, 2015 Uppergate Dr, Atlanta, GA, USA

Boghuma K. Titanji

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Contributions

Colleen Shelly, MPH: conceptualization, data collection, management and analysis, writing, reviewing, editing, corresponding author. Caroline Logan, MSc: conceptualization, management, writing, reviewing, editing. Beth Skorochod, MPH: conceptualization, management, writing, reviewing, editing. Alison Wiyeh, MD MSc: interviewee, review of final manuscript. Duduzile Ndwandwe, PhD: interviewee, review of final manuscript. Augustine Choko, PhD MSc: interviewee, review of final manuscript. Innocent Valea, PhD MSc: interviewee, review of final manuscript. Boghuma K Titanji, MD MSc DTM&H PhD: interviewee, review of final manuscript. The authors read and approved the final manuscript.

Corresponding author

Correspondence to Colleen E. Shelly .

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As this study was a qualitative and quantitative review of publicly available protocols and interviews with subject matter experts, we did not seek approval from an institutional review board.

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The authors declare that they have no competing interests.

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Supplementary Information

Additional file 1..

Interview guide for clinical trial experts

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Shelly, C.E., Logan, C., Skorochod, B. et al. Creating a best practice template for participant communication plans in global health clinical studies. Trials 24 , 158 (2023). https://doi.org/10.1186/s13063-023-07185-4

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Received : 14 December 2022

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DOI : https://doi.org/10.1186/s13063-023-07185-4

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