Endpoint Adjudication Committees

Ensure that Trial Data is “as Accurate and Free of Bias as Possible”

We quote the FDA’s 2017 update to “Guidance for Clinical Trial Sponsors – Establishment and Operation of Clinical Trial Data Monitoring Committees” (3.3, p 7). Although the FDA has not yet required Endpoint Adjudication (EA) for trials in all therapeutic areas, it clearly sees the value that well-executed Adjudication Committees work can provide for trials preparing for regulatory review.

How eAdjudication® Support Effective Endpoint Adjudication Committees

eAdjudication® software features and services don’t leave room for error. They are designed to lead the Adjudication Committeee Operations enforcing quality and eliminating mistakes. The eAdjudication® Software Managed Services support the Clinical Adjudication process through user-friendly cloud-based services, comprehensive features and capabilities.

Even before committee members become involved, eAdjudication® manages their engagement by establishing qualifications and training levels, and allowing the assignment of events to the appropriate reviewers. Committee members work with user-friendly Adjudication Forms which facilitate an efficient assessment. The eAdjudication process moves quickly and efficiently, with excellent data visualization, real-time updates and action alerts – all tracked in a clear audit trail. Adjudication coordinators oversee the entire process with a real-time smart-reporting page that triggers alerts when events await submission, assessments are pending or more data is requested by reviewers. The system also plans consensus meetings in case of disagreement.

Discover How eAdjudication® Helps Endpoint Committee Members

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DOWNLOAD Ethical's complete Endpoint Adjudication Charter Guide

Request your FREE copy of the Adjudication Charter Guide built by Ethical after reviewing more than 20 study charters. Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats.

Event Adjudication Charter GuideREAD MORE

Handling changes in patient data during the Adjudication study: it is not carved in stone

Changes, corrections or additions to patient data may occur during a clinical trial and may impact endpoints assessment. Ensuring close monitoring and facilitating prompt action is the role of a well-thought endpoint adjudication software platform.

Handling changes in patient data during the Adjudication study: it is not carved in stoneREAD MORE

Training the Endpoint Adjudication Committee Members

It comes to the sponsor to ensure that EAC members are adequately trained (and occasionally re-trained) in the procedures and approaches of the particular study.

Training the Endpoint Adjudication CommitteeREAD MORE