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FDA Webinar: Final : Electronic Source Data In Clinical Investigations (Procedural) - 29-01-2014


On January 29, 2014, from 2:00PM - 3:00PM EST, FDA will present a webinar on a final guidance for industry titled “Electronic Source Data in Clinical Investigations."

The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled “Electronic Source Data in Clinical Investigations.” This final guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance 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.

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Bookmarked by Harry van Loen on Jan. 23, 2014