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FDA publishes guidance on Electronic Data Capture in eCRFs 24/10/2013

Posted by Shirley Hallam in Quality Management.

EDCThe United States Food and Drugs Administration (FDA) has published new guidance on the use of electronic data capture in clinical trials.
The guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol and includes the following areas:

• Identification and specification of authorized source data originators
• Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
• Ways to capture source data into the eCRF using either manual or electronic methods
• Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
• Use and description of computerized systems in clinical investigations
This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations, and on Electronic Records and Electronic Signatures.
The full text of the guidance can be found on the FDA website.


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