Regulatory Updates

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