This article is part of the network’s archive of useful research information. This article is closed to new comments due to inactivity. We welcome new content which can be done by submitting an article for review or take part in discussions in an open topic or submit a blog post to take your discussions online.

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


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'