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.
The project management life cycle for clinical trials is comprised of:
- Study start-up
- Team management
- Clinical assessment
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.
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.
- Research idea:
- 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
- Baseline testing:
- Perform initial assessments
- Conduct study group
- Monitor progress
- Follow-up testing:
- Test outcomes for changes
- Data analysis:
- Prove/disprove hypothesis
- Assess outcomes
- Publish findings
Tools for Study Start-up
- Program organizational chart:
- 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
- Process flows:
- 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
Tools for Team Management
- Document libraries:
- 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
- Action items:
- 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
- Advertising timeline:
- Timeline of recruitment and advertisement events
- Yield rates of completed events
- Recruitment goal tracking:
- Identify and track study recruitment requirements
- Assess monthly/quarterly randomization goals
- Monitor progress
- Adjust advertising campaigns as needed
- Recruitment budget tracking:
- Identify and track study recruitment budget
- Assess cost effectiveness of advertising campaigns
- Adjust advertising campaigns as needed
- Participant flow diagram:
- Assess throughput:
- Determines screening yields
- Assess where participants are lost due to dropouts or exclusionary criteria
- Determine ratio of phone screens to randomization
- Provide information on the current and past pipeline:
- Stage of the process for pending participants
- Management of N in each arm of the trial
- Follow-up visit completion rates
- Assess throughput:
- Enrollment predictions
- Assess pending pipeline
- Use throughput rates to predict enrollment
- Predict quantity needed to reach goals
Tools for Clinical Assessment
- Electronic CRFs:
- Paperless electronic data capture systems
- Participant self-reported forms captured via surveys
- Auto-generated timed survey requests for completion
- Visit scheduling:
- Calculated visit windows for follow-up testing
- Tracking scheduled and actual visit dates
- Pending visit reports
Tools for Intervention
- Real-time data capture:
- Paperless electronic data capture systems
- Real-time data
- Easily accessible compliance reports
- Adherence and compliance reporting:
- Assess participant compliance monthly
- Identify discrepancies and any areas of concern
- Retention tracking:
- 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