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Endpoint Adjudication: MediData Rave Medical Records in eAdjudication

By Mimmo Garibbo 22 Jan, 2018

Endpoint Adjudication: using MediData Rave Medical Records in eAdjudication

A technical approach to transfer Events and Medical Records from the Medidata Rave EDC platform to eAdjudication Software for Clinical Endpoint Adjudication.

MEDICAL RECORDS FOR ENDPOINT ADJUDICATION
Endpoints adjudication implemented in Clinical trials can help improve the quality of study results by reducing bias in the Endpoints Assessments. When a clinical trial relies on subjective endpoints or involves investigators working in different countries, individual assessments may vary or become biased. 

Sponsors or Health Authorities may request a verification of the investigators’ conclusions (disease diagnosis or severity, classification of adverse events, disease progression or regression, tumour size measurements, etc.) by an independent group of experts (the Adjudication Committee) centrally duplicating the same assessment. These independent reviewers are usually blinded in respect to each other’s opinion and to identification information such as patient, site and country.

The eAdjudication® software platform is designed to support Endpoint Adjudication Committee Members by providing a secure and controlled environment for receiving information related to the events to be judged and for recording their judgement.
In order to support the assessment, the eAdjudication system must be able to retrieve the Medical Records related to all potential endpoints and assemble a comprehensive package made of documents, data or images coming from external systems used for the trial data management.
If an Electronic Data Capture (EDC) system is used in the study, it is likely to be the main source for most of this information.

IF MEDICAL RECORDS ARE COLLECTED WITH MEDIDATA RAVE®
Medidata Rave is a leading Electronic Data Capture (EDC) solution employed to collect patient data for hundreds of clinical trials. We present here the data management process for integrating Medidata Rave with Ethical eAdjudication® and describe how to use this integration to detect potential endpoint-related data in the EDC database and automatically create or update the related Event Package in the eAdjudication® repository.

INTEGRATION OF eADJUDICATION® AND MEDIDATA RAVE®
We have implemented an effective and flexible way for creating and updating events in eAdjudication® by establishing a direct integration with Medidata Rave® using web services and API methods available in both platforms.  

We have created a Data Connector Program that can be connected directly to the Rave database and is able to extract all new patients’ medical records coded in CSV data format. When certain predefined conditions, usually detailed in the Adjudication Charter, are met, the connector translates the relevant data from the Medidata Rave format to the CSV structure required by eAdjudication®. These data are then imported directly in the eAdjudication® database and used to create or update the event packages related to new or existing endpoints queued for adjudication.

The Medidata Rave Connector Flow
Summarizing the connector program will work following these steps:

  1. Establish a connection with Medidata Rave by using its webservices (RWS)
  2. Extracts patients’ data from Medidata Rave system in CSV
  3. Checks data, to identify if data meets the criteria specified in the charter of the adjudication.
  4. Use eAjudication webservices (EWS) to create some new events or to update existing ones.

The connector can be scheduled to run during a specific timeframe (e.g. during the night) and it can also be designed to call other eAdjudication API methods.
E.g. to alert the Adjudication staff or to make other data transformation tasks.

*Medidata Rave and any other registered trademark are the property of their respective owners.

 


Clinical Adjudication, Endpoint Adjudication, Central Endpoint Committee CEA, Clinical Event Committee - CEC, Adjudication Software - EAS, Medidata Rave, Electronic Data Capture

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