Proper training of adjudication committee members ensures reviewers understand the adjudication charter and can confidently use the platform. Timing, format, and thorough documentation play a key role in the process, and when it comes to convenience and flexibility, one training format stands out. Find out which.
Clinical endpoint adjudication has become a cornerstone of high-integrity clinical trials. It ensures that clinical events - often complex and nuanced - are assessed in a standardized, unbiased manner by an independent committee of experts. While adjudication committee members (or "reviewers") are typically highly experienced clinicians, expertise alone is not sufficient to guarantee compliance, consistency, and audit-readiness. Appropriate training ensures optimal and compliant use of the adjudication tools and processes.
More Than Clinical Expertise
Adjudication committee members are often leading experts in their field. They may have helped draft the clinical protocol or participated in similar studies. Their qualifications are documented in the trial master file (TMF), as required under Good Clinical Practice (GCP). However, clinical trials frequently involve workflows and documentation requirements that differ significantly from routine clinical care. Expertise in medicine must therefore be complemented by a clear understanding of the adjudication process and tools.
Understanding the Adjudication Charter
The adjudication process is governed by a detailed document known as the Adjudication Charter. This charter outlines everything from the definitions of events to be adjudicated, to the decision-making workflows, quorum rules, and dispute resolution mechanisms. Training ensures that each committee member understands not only the content of the charter, but also how to apply it consistently.
Without proper training, even minor misinterpretations can lead to inconsistencies in event classification - putting data integrity at risk. Training sessions should provide real-world examples, explain edge cases, and clarify areas of potential ambiguity. This helps ensure that all committee members are aligned in their interpretation and execution of the adjudication process.
Mastering the Adjudication Software
Modern adjudication is almost always conducted using specialized software platforms designed to streamline review workflows, protect blinding, and ensure traceability. These platforms may include document viewers, voting interfaces, adjudication timelines, audit trails, and role-based permissions. Even highly tech-savvy clinicians need structured, hands-on training to use these systems confidently and correctly.
Training on the platform is not just about technical orientation. It includes understanding how to navigate secure data environments, avoid operational errors, and complete reviews in line with compliance protocols. Improper use of the software - such as uploading feedback to the wrong section or missing a voting deadline - can compromise both the timeline and the credibility of a study.
Timing, Format, and Documentation of Training
Best practice dictates that adjudication training be provided before the start of the study and be tailored to the specific protocol and software platform in use. In some cases, refresher sessions or retraining may be required mid-study, especially when new members join or major updates to the protocol or platform occur.
Training can be delivered by the sponsor, a consultant, or even a fellow committee member with suitable experience. Regardless of the format - live session, webinar, or digital module - training must be documented in the Trial Master File. Records must include a description of the training, the trainer's credentials, and signed, dated confirmation from each attendee.
The Value of Easily-Accessible Video Training
Asynchronous video training offers committee members a flexible and effective way to prepare, especially when the adjudication platform is intuitive and user-friendly. A well-designed training video allows reviewers to learn at their own pace, revisit key sections as needed, and gain both technical and procedural clarity in a time-efficient format. These recordings typically combine a walkthrough of the adjudication system interface with a clear explanation of the adjudication process outlined in the charter. This dual focus not only improves usability but also reinforces consistent application of the adjudication rules across all cases. To maximize its usefulness, the video training should be easily accessible at all times from within the platform, enabling committee members to refresh their knowledge whenever necessary. Finally, to meet documentation and compliance standards, the training should include a step where reviewers can confirm - by ticking and signing - that they have watched and understood the material, with records archived in the Trial Master File.
Conclusion
At Ethical Clinical GmbH, we view adjudication training not as a formality but as a foundation for trial success. It safeguards consistency, enhances efficiency, supports regulatory compliance, and ultimately contributes to high-quality clinical data. How your training is delivered can make a difference. Easily-accessible video training offers the clarity, flexibility, and traceability required in today’s clinical environment. With a user-friendly software as intuitive as Ethical’s, a ten-minute video training has proven sufficient for most studies, ensuring reviewers are ready without unnecessary complexity.
If you're looking to strengthen your adjudication processes with expert support and smart training solutions, we're here to help. Contact Ethical to learn how we can tailor our tools to your next trial. Please use the form below.
