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2010-09-22
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Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability
Notices
D09002ee1bde2092b
D09002ee1bde209a3
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 document entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated March 2006. The guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for study monitoring, and how such committees should operate. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated November 2001.
71 FR 15421
https://www.govinfo.gov/app/details/FR-2006-03-28/E6-4428
E6-4428
fr28mr06-73
4160-01-S
Docket No. 2001D-0489
https://www.govinfo.gov/app/details/FR-2006-03-28/E6-4428
https://www.govinfo.gov/content/pkg/FR-2006-03-28/html/E6-4428.htm
https://www.govinfo.gov/content/pkg/FR-2006-03-28/pdf/E6-4428.pdf
2 p.
15421
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71 FR 15421
Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability; Federal Register Vol. 71, Issue
NOTICE
E6-4428
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2001D-0489
4160-01-S
E6-4428
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated March 2006. The guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for study monitoring, and how such committees should operate. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated November 2001.
Submit written or electronic comments on agency guidances at any time.
Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827- 6210; Robert Temple, Center for Drug Evaluation and Research (HFD-40), 5600 Fishers Lane, Rockville, MD 20857, 301-594-6758; or Joanne Less, Center for Devices and Radiological Health (HFZ-403) 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.
Reports and guidance documents; availability, etc.:
Clinical trial sponsors; clinical trial data monitoring committees; establishment and operation,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/cder/guidance.htm
http://www.fda.gov/cdrh
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 71, no. 59
Office of the Federal Register, National Archives and Records Administration
2006-03-28
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daily
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247 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2006-03-28
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https://www.govinfo.gov/app/details/FR-2006-03-28
https://www.govinfo.gov/content/pkg/FR-2006-03-28/pdf/FR-2006-03-28.pdf
https://www.govinfo.gov/content/pkg/FR-2006-03-28/xml/FR-2006-03-28.xml
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2010-09-22
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FR-2006-03-28
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