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Endpoint Adjudication: Matching Changes in Trial Processes

By Dimitri Stamatiadis 08 Jan, 2019

Matching Changes in trial processes: It is not a freefall

Fine-tuning during the conduct of a clinical trial may lead to changes in some of the parameters. Adjusting the Endpoint Adjudication Database in time ensures a smooth monitoring and supports data quality.

Once set up, an endpoint adjudication (EA) platform can be a very handy tool for managing and monitoring EA operations. All settings are based on a charter agreed and signed between the sponsor, the committee, the CRO (if one is involved) and potentially approved by regulatory authorities. 

But a clinical trial is not a freefall. Things may (and do) change along the way.

And they should because such complex setup, even done by experienced professionals, is rarely perfect. Processes change, forms change charters get amended. So be it. And these changes need to be recorded precisely and accurately in order to preserve the integrity and quality of the study.

An endpoint adjudication platform must be capable of tracking all such changes and the settings of the system must be adjusted without any loss in continuity or traceability.

Ethical's eAdjudication, is the most advanced EA platform available to clinical research professionals. Designed with flexibility in mind, it allows easy and quick adjustment of all parameters, confirmed by the appropriate user access and based on approved charter or process versioning.

 

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Endpoint Adjudication, Clinical Adjudication, Adjudication Charter

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