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Guidance on Electronic Source Data in Clinical Trials

09/18/2013

Federal Register Notice: FDA is making available a guidance for industry entitled Electronic Source Data in Clinical Investigations. It provides guidance to sponsors, contract research organizations, clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. The document promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission. To download this guidance, click here. To view this notice, click here.

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