Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees.
| Other Authors: | Center for Biologics Evaluation and Research (U.S.), Center for Drug Evaluation and Research (U.S.), Center for Devices and Radiological Health (U.S.) |
|---|---|
| Format: | Electronic |
| Language: | English |
| Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health,
[2001]
|
| Physical Description: |
ii, 23 pages : digital, PDF file. |
| Subjects: | |
| Online Access: |
https://purl.fdlp.gov/GPO/LPS113180 |
| Item Description: |
Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/clindatmon.pdf ; current access is available via PURL. Title from PDF title page (viewed on May 28, 2009). "Draft guidance". "November 2001". GPO Cataloging Record Distribution Program (CRDP). |
|---|---|
| Physical Description: |
ii, 23 pages : digital, PDF file. |
| Format: |
Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/clindatmon.pdf ; current access is available via PURL. |