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Endpoint Adjudication: Missing Data and Reviewers' Queries

By Dimitri Stamatiadis 27 Nov, 2018

Endpoint Adjudication: Missing data, reviewers queries and the site communication plan

Connecting investigational sites to the Endpoint Adjudication Committee to facilitate the request of additional or missing data in a fast, simple, confidential and blinded way is the role of a well thought endpoint adjudication platform.

Endpoint adjudication by an independent expert committee is an operation that goes on during the entire length of a clinical trial.
In spite of all the efforts to collect and transmit the appropriate data to the adjudication committee in the fastest and most direct way, it is frequent that the reviewers notice missing or inconsistent data, require some clarification or need a complement of information. 

Good and fast communication between the site and the committee is therefore paramount for the timely assessment of endpoints and since the committee must be totally blinded to the origin of the information, the endpoint adjudication software platform, the Endpoint Office (CEC Staff) and the sponsor play a key role in the process.

 

Endpoint Adjudication Process Flow with Ethical eAdjudication

 

Manual management of the complementary or updated information can prove much more complex that the initial flow of information which obeys standard rules applicable to all cases and described in the study documents such as the adjudication committee charter. Here we are dealing with specific requests for data which have in principle been missed by the standard process. They need to be located, extracted from the patients’ records and re-injected in the standard circuit in order to reach the reviewers and be incorporated in the adjudication process. 

eAdjudication allows study coordinators to monitor the emergence of events and the progress of the adjudication process, to facilitate intermediary operations such as redaction (anonymization) and/or translation of source documents, to identify outliers and to streamline the process of assessment.

eAdjudication connects the sites with the CEC Committee Members ensuring the blinding of all identifiers, preserves data integrity and confidentiality and guarantees compliance by recording all actions in an ultra-secured audit trail. In addition, aAdjudication records time between operations and a number of other parameters to build robust dashboard views and pilot the study conduct.

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Endpoint Adjudication, Adjudication Panel, Central Event Committee - CEC, Clinical Event Committee - CEC, Adjudication Software - EAS, Central Endpoint Committee CEA

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