real-time adjudication

By Ethical 18 Feb, 2020

What's Real Time Adjudication?

There can be a benefit in grouping adjudication cases and review them all together. On the other hand, real time adjudication powered by an electronic platform can help streamline the trial and make useful decisions on the fly. If applying Real Time Adjudiction decision is to be taken by the study team depending on a number of factors.

Endpoint adjudication (EA) by an independent expert committee (IEC) is a great way to improve the quality and homogeneity of clinical trial endpoint results. Whether requested by regulatory authorities or chosen by a trial sponsor to strengthen the quality of trial endpoints, endpoint adjudication (EA) is undeniably adding complexity to the planning and execution of a clinical trial. If that complexity is not managed with the proper tools it can translate into additional time and cost but this should not be a fatality.

Grouping cases and reviewing them in dedicated sessions provides consistency and a chance to compare several cases for similarities or differences. This approach can be done manually and has the advantage to allow time for collecting the necessary documentation. Reviewers can plan to set time apart for this step ahead of time and there is time to clean up the clinical database before adjudication takes place. A potential systematic bias can however arise from reviewing many similar cases together. 

Real time adjudication, on the other hand, allows to keep the study flowing, use adaptive design and adjust parameters where allowed by the protocol. Real-time adjudication allows quick, individualized and unbiased review of cases as they present provided that the appropriate mechanisms are in place for collection, anonymization, control and transfer of information. Real time adjudication also reduces delays at the end of the study (a time when much is happening and delays tend to occur), and allows for adjustments and corrections during the conduct of the trial.

A cloud-based platform such as eAdjudication® is the best way to perform real time adjudication in a compliant and consistent way by connecting in real time investigators, sponsors and adjudicators. The platform handles, based on the committee charter rules, role-based access, workload distribution, quality assurance and disagreement resolution. eAdjudication® for real time adjudication is your best chance to win the race against time without losing the race against budget. 

The Complete Manual / Reference Book (34 pages) with all the topics related to the Independent Endpoint Adjudication Committees Management

Real Time Adjudication, Endpoint Adjudication Process


Download Ethical eAdjudication for Endpoint Adjudication Dossier

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