United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Notices D09002ee1c80b0698 D09002ee1c80b0730 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Computerized Systems Used in Clinical Investigations," dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the 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supersedes the guidance entitled "Computerized Systems Used in Clinical Trials," dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled "Part 11, Electronic Records; Electronic Signatures--Scope and Application," dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites. 72 FR 26638 https://www.govinfo.gov/app/details/FR-2007-05-10/E7-9056 E7-9056 fr10my07-90 4160-01-S Docket No. 2004D-0440 https://www.govinfo.gov/app/details/FR-2007-05-10/E7-9056 https://www.govinfo.gov/content/pkg/FR-2007-05-10/html/E7-9056.htm https://www.govinfo.gov/content/pkg/FR-2007-05-10/pdf/E7-9056.pdf 2 p. 26638 26639 72 FR 26638 Guidance for Industry on Computerized Systems Used in Clinical Investigations; Availability; Federal Register Vol. 72, Issue NOTICE E7-9056 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 2004D-0440 4160-01-S E7-9056 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Computerized Systems Used in Clinical Investigations," dated May 2007. This document provides to sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in clinical investigations. Because the source data in source documentation are necessary for the reconstruction and evaluation of the trial to determine the 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 entitled "Computerized Systems Used in Clinical Trials," dated April 1999; finalizes the draft guidance of the same title dated September 2004; and supplements the guidance for industry entitled "Part 11, Electronic Records; Electronic Signatures--Scope and Application," dated August 2003, and FDA's international harmonization efforts when applying guidance to source data generated at clinical study sites.

Submit written or electronic comments on agency guidance at any time. Patricia M. Beers Block, Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340. Reports and guidance documents; availability, etc.: Computerized systems used in clinical investigations; industry guidance, http://www.fda.gov/dockets/ecomments http://www.fda.gov/oc/gcp http://www.fda.gov/ohrms/dockets/default.htm Vol. 72, no. 90 Office of the Federal Register, National Archives and Records Administration 2007-05-10 continuing daily deposited born digital 185 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-05-10 P0b002ee180949bb4 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10my07 https://www.govinfo.gov/app/details/FR-2007-05-10 https://www.govinfo.gov/content/pkg/FR-2007-05-10/pdf/FR-2007-05-10.pdf https://www.govinfo.gov/content/pkg/FR-2007-05-10/xml/FR-2007-05-10.xml fdlp 26533 26708 DGPO 2010-09-22 2024-06-05 FR-2007-05-10 machine generated eng FR FR-2007-05-10 72 90