FDA Issues Draft Guidance on Electronic Documentation

The US Food and Drug Administration (FDA) has recently published a draft guidance, “Electronic Source Documentation in Clinical Investigations,” on the role of electronic source documentation in clinical investigations such as those conducted for some medical devices. Targeting sponsors, contract research organizations, data management providers and clinical investigators, the FDA guidance pushes for capturing clinical investigation source data in electronic form in order to cut down on unnecessary data duplication, reduce transcription errors and increase real-time data entry. The new guidelines were issued to complement industry guidances previously issued by the FDA including Part 11 of “Computerized Systems Used in Clinical Investigations” and “General Principles of Software Validation.” The agency has also solicited comments on the draft guidance; industry participants have 90 days to submit their commence before final issuance.

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