FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations

Title:
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations

https://www.gmp-compliance.org/files/guidemgr/7359fnl.pdf

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070266.pdf

Content:
This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations

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