Connecting investigational sites to the Endpoint Adjudication Committee (EAC) to facilitate the request of additional or missing data in a fast, simple, confidential and blinded way is the role of a well thought electronic 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 endpoint 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 endpoint adjudication committee is therefore paramount for the timely assessment of endpoints. Since the committee must be totally blinded to the origin of the information, the electronic adjudication platform and the sponsor administrator play a key role in the process.
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.
An electronic adjudication platform such as eAdjudication® allows study coordinators to monitor the emergence of events and the progress of the adjudication process, to facilitate intermediary operations such as redaction and/or translation of documents, to identify outliers and to streamline the process of assessment. eAdjudication® connects the sites with the endpoint adjudication committee 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, eAdjudication® records time between operations and a number of other parameters to build robust dashboard views and pilot the study conduct.
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