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Human Subjects Division (HSD)

Regulatory Updates

FDA: Draft Guidance for Industry: Electronic Source Documentation in Clinical Investigations

Jan 13, 2011 at 12:13am
This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations.  This guidance is intended to ensure the reliability, quality, integrity, and tracability of electronic source data and source records maintained at the site for FDA inspection. See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf