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GUIDANCE DOCUMENT

Computerized Systems Used in Clinical Investigations Guidance for Industry May 2007

Final
Docket Number:
FDA-2004-D-0039
Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition
Office of Medical Products and Tobacco, Office of Special Medical Programs, Office of Good Clinical Practice
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
Office of Foods and Veterinary Medicine, Center for Veterinary Medicine

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.  The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA.  Because the source data are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (i.e., electronic records).   

This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures — Scope and Application and the Agency's international harmonization efforts when applying these guidances to source data generated at clinical study sites.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0039.