Navigating the Closeout Stage of Clinical Trial Management

scientists collaborating in a clinical trial lab

What is Involved in Clinical Trial Management?

Clinical trial management involves the work and dedication of a project manager to ensure that every part of the trial runs smoothly, from start to finish. A clinical trial study includes a startup, maintenance, and closeout stage.

During the study startup stage, the project manager will work with the client to establish regular communication, understand the scope, budget, and schedule for the trial, and finalize any necessary documentation. The goal of the startup stage is to get the trial off to a successful start. The startup stage typically involves the first three months of the study and ends with customized collection kits being sent to every site, allowing enrollment to begin.

The second stage is study maintenance, which takes up the most significant portion of the clinical study timeline and can last from six months to ten years or longer. During maintenance, the project manager will ensure that the trial remains on time and within budget and will make necessary changes to the scope of the trial depending on certain events. This stage aims to mitigate any risks and regularly clean data to help ensure a successful closeout stage.

The final stage of clinical trial management is closeout, taking up the last three months of the process. Closing out the study involves ensuring that all activities from the trial have been accurately reconciled, documented, and reported. Once the clinical study report has been finalized after the database lock, the study is considered closed.

What Happens During the Closeout Stage of Trial Management?

The focus of the closeout stage of clinical study management is on data, sample collection, and making final deliverables. The closeout stage involves the following:

1. Data Cleaning

Data cleaning involves recognizing any errors in the data, such as incorrect or duplicate data, and correcting and updating them. Data cleaning is an essential part of the maintenance stage but also occurs during the closeout stage before the final data transfer.

2. Sample Shipments

Upon concluding the clinical trial, ACM will work with the client to determine what happens to the samples. Typically, samples will either go into long-term storage, be shipped off to the final referral lab destination, or may be temporarily held until going through a disposal process.

3. Final Deliverables

The most anticipated part of the closeout stage of study management is receiving the final deliverables. At the end of the trial, ACM ensures that clients receive the following:

  • Final data transfer: The final data transfer is the cleaned, updated version of all the data collected throughout the life of the clinical study.
  • Validation report: A full report will be provided to the client if ACM has performed any specialty testing validation, such as PK testing.
  • Document reconciliation: After the final data transfer, ACM will provide a final, signed version of the global laboratory specification document (GLSD).
  • FDA validation: In some cases, the FDA might have questions for ACM before approval. ACM will pull any necessary data or documentation to prove validation if necessary.

How to Prepare for a Successful Closeout Stage

Preparing for a successful closeout stage begins at startup, with established communication, transparency, and consistency between the ACM project manager and the client. Before the trial enters the closeout stage, there are some things to consider that can help ensure success.

1. Be Aware of Database Lock

One of the main threats to a clinical study during the closeout stage is not meeting the deadline for the final data transfer. This is often due to a lack of data cleaning throughout the study.

According to ACM Director of Project Management Regina Harrison, “If you don’t reconcile data throughout the course of the study, you risk hitting data lock.” She states that “We clean data on a quarterly basis, which includes comparing our data to the client’s clinical database and clearing up any discrepancies along the way.”

The project manager will also consider any batch testing done with a third-party lab during the data cleaning process.

2. Leave Time for Sample Shipping

As the end of the trial approaches, there needs to be ample time to prepare and ship the rest of the samples that are in-house. Clients should also avoid scheduling subjects too close to the data transfer deadline since there needs to be time after the last subject sample to clean and reconcile data.

Why Work with an ACM Clinical Trial Project Manager

At ACM, our project managers are an extension of our client’s team, providing expert support throughout the trial management process. By partnering with a clinical trial project manager, you can help ensure that your trial remains on schedule, within budget, and on a path to a successful closeout stage. Your project manager will also maintain all documentation that you may need at the end of a clinical trial study with final deliverables you can trust.

ACM Global Laboratories can connect you with an expert clinical study project manager. For support on your next clinical trial, contact ACM today.

central lab banner with test tubes

Need Guidance for Your Clinical Study?

With experience and powerful industry insight, AMC Global Laboratories is available to work alongside your organization throughout the clinical trial process.

Talk to Our Expert Team