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When an investigational device is given to or used with a subject, a record of the use of the device is provided to the sponsor by recording the use on the Case Report Form (CRF).

A Case Report Form (CRF) is an electronic paper document which is used in a clinical trial to record the protocol and required information about each participant.

Case Report Form (CRF) is created and used in clinical trial research to capture standardised clinical record from each patient separately and to transfer it to Data Management.

Case Report Form enables efficient and complete data collection, processing, analysis and reporting.

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Universidad de Mexico