Electronic Source Data in Clinical Investigations by FDA

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This is a nice guidance document on principles in electronic data capture from Industry perspective (FDA)

Yves

Introduction paragraph:
'In an effort to streamline and modernize clinical investigations, this guidance provides 15 recommendations to sponsors, Contract Research Organizations (CROs), data management 16 centers, clinical investigators, and others involved in capturing, reviewing, and archiving 17 electronic source data in FDA-regulated clinical investigations. This guidance promotes 18 capturing source data in electronic form, and it is intended to assist in ensuring the reliability, 19 quality, integrity, and traceability of electronic source data'