Image source:

How to Create a Clinical Trial Study Close-out Checklist

An important document for every clinical trial study is the close-out checklist. This document gives both the study team and the sponsor a list of tasks to do during the study. There are certain checklists that are required by law, but many are optional. This blog aims to help you understand the purpose of each checklist, which are required by law, which are optional, and which are best to use for your study.

The first step is to identify which checklist items will be most useful for your study. This must be determined based on the type of clinical trial you are running.  For example, if you are conducting a pediatric study using an approved device, then said device might need to be returned at the end of the study. 

At the end of a clinical trial, you need to gather data from ALL study sites and compile your results. You will likely want to keep all documents that could be helpful for future reference. This is also the time when you should find out whether there were any problems with participants or research staff during the course of the study. If so, make sure to document these issues in both your activities log and on your close-out checklist. Then you should submit a final report to an oversight committee as well as all other relevant groups (i.e., institutional review board).

Why Closure Strategies Are Important

There are many reasons why the process of closing a trial is important. This process can help to:

Keep Team Members On Track

Closer to the end of the trial, team members such as stakeholders might begin to lose focus.  This is because a trial can become tedious, and team members might feel that they have already provided all the data that they need. A closure strategy can help keep team members on track so that their hard work does not go to waste.

Follow Best Practices

Managing a project all the way through to the end can be difficult. A closure strategy for a clinical trial can help to make sure all best practices are followed. Failing to create a clinical trial study close-out checklist might lead to data that is not stored properly or cannot be accessed.

Maximize Successful Data Collection

A well-thought-out closure process can help ensure that all of the necessary data has been collected and stored in a way that will benefit future research and development. If you do not take the time to create a clinical trial study close-out checklist, there is a chance that important data could get lost and ultimately hinder future projects.

Create an Action Plan

When your team members understand how to work together toward completing the main objective, they will feel empowered and involved in their role as contributors towards achieving those goals. Your team members should know what they need to do each day and should be able to work towards logically meeting their goals.

Formulate a Plan For Future Studies

At some point, you will likely need to initiate another study.  Developing a solid plan from the outset of your first study might make this process easier. As you work with your clinical trial study close-out checklist, you will want to think about how the next study could be improved. 

Manage Costs

A close-out strategy should also include a budget and the process to return the funds if they are not needed for study completion. Keeping all of your ‘i’s’ dotted and ‘t’s’ crossed can help ensure that you get back what you need to finish the job!

Tie Up Loose Ends

A closing checklist will help identify any missing puzzle pieces. For example, you might want to review your data collection forms to make sure that there are no incomplete submissions.

Finalize ALL Documents

Close-out is not complete until all of the final documents have been disseminated. Whether it’s a regulatory document or an internal memo, leaving loose ends can result in uncomfortable conversations later! 

Clarify and Ease Transitions

Transitioning the project to a new owner can be complicated. Make sure that all parties are clear on the goals, timelines, and deliverables. You can also ease this process by giving your replacement a formal hand-over memo or checklist.

Boost Project Management Credentials

Properly following a close-out process demonstrates your organization’s commitment to excellence. Managing projects is critical for new business development, so the efficiency of your close-out will likely be a valuable addition to your resume.

Learn from Mistakes and Celebrate Wins

It is important to learn from mistakes, but it is equally important not to dwell on them. Acknowledge any glitches that occurred during the project (i.e., missed deadlines) and highlight areas where you went above and beyond the original request (i.e., additional deliverables).

Standard Project Close-Out Checklist Items

The following items are often included in a clinical trial study close-out checklist:

  1. Review the project scope and ensure all activities are fully completed.
  2. Examine the project documentation for completeness and accuracy.  Check for signatures, dates, and project identification numbers.
  3. Finalize payments.  If the study is being conducted using federal funds, ensure that any remaining balance on your grant or contract is repaid.
  4. Debrief to identify lessons learned.  The success of the study should be examined relative to the goals.
  5. Finalize reports.  In the event that your organization requires a final report, make sure it is complete.
  6. Update your inventory and ensure that any unused materials are returned or properly disposed of in accordance with appropriate guidelines.
  7. Submit a final report, including documentation of all project deliverables, to all parties involved in the project (i.e., sponsor).
  8. When possible, conduct a closeout meeting with all team members to acknowledge the accomplishments of the project.

In conclusion, those responsible for managing clinical trials must understand the importance of knowing where their studies stand using a close-out checklist. By doing so, they can better monitor the progress and ensure the timely delivery of their services. 

Share this article

Deepak Behera is a physician-scientist turned executive, with expertise in clinical development and medical affairs across clinical, academic, and pharmaceutical/biotechnology sectors. He has over 12 years of experience in clinical research and related regulatory policies and submissions. Deepak’s goal is to push healthcare towards better patient outcomes, while at the same time generating value for all stakeholders. Democratizing clinical trials for patients and physicians aligns perfectly with this goal, and is why he founded Adaptive Research. In addition, Deepak provides strategic and operational advice to multiple pharmaceutical and biotechnology companies in the areas of clinical development, medical affairs, and technology assessment. He received his MD from MKCG Medical College at Berhampur University in India, and earned his board certification in nuclear medicine from India’s National Board of Examinations. He serves on committees and boards of various professional societies, including the Society of Nuclear Medicine and Molecular Imaging and the Indo-American Society of Nuclear Medicine. In his free time, Deepak likes to mentor young professionals, play volleyball, go for long drives and have fun with his two kids.

Facebook Comments