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2010-09-22
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Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability
Notices
D09002ee1bde6ce34
D09002ee1bde6d0ea
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Computerized Systems Used in Clinical Trials.'' This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999.
69 FR 59239
https://www.govinfo.gov/app/details/FR-2004-10-04/04-22204
04-22204
fr04oc04-72
4160-01-S
Docket No. 2004D-0440
https://www.govinfo.gov/app/details/FR-2004-10-04/04-22204
https://www.govinfo.gov/content/pkg/FR-2004-10-04/html/04-22204.htm
https://www.govinfo.gov/content/pkg/FR-2004-10-04/pdf/04-22204.pdf
2 p.
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69 FR 59239
Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability; Federal Register Vol. 69, Issue
NOTICE
04-22204
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2005-01-03
Docket No. 2004D-0440
4160-01-S
04-22204
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Computerized Systems Used in Clinical Trials.'' This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999.
Submit written or electronic comments on the draft recommendations by January 3, 2005. General comments on agency guidance documents are welcome at any time.
Joseph Salewski, Center for Drug Evaluation and Research (HFD-45), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 301-594-0020; or
Reports and guidance documents; availability, etc.:
Computerized systems used in clinical trials,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/cvm/guidance/guidance.html
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/oc/gcp/draft.html
Federal Register
Vol. 69, no. 191
Office of the Federal Register, National Archives and Records Administration
2004-10-04
continuing
daily
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437 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2004-10-04
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr04oc04
https://www.govinfo.gov/app/details/FR-2004-10-04
https://www.govinfo.gov/content/pkg/FR-2004-10-04/pdf/FR-2004-10-04.pdf
https://www.govinfo.gov/content/pkg/FR-2004-10-04/xml/FR-2004-10-04.xml
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2010-09-22
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FR-2004-10-04
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191