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E-REPORT
Title Guidance for clinical trial sponsors [electronic resource] : on the establishment and operation of clinical trial data monitoring committees.
Imprint 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]

Copies/Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
Description ii, 23 p. : digital, PDF file.
Note Title from PDF title page (viewed on May 28, 2009).
"Draft guidance".
"November 2001".
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.
Subject Clinical trials -- Government policy -- United States.
Other Author Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
Center for Devices and Radiological Health (U.S.)
Other Title On the establishment and operation of clinical trial data monitoring committees.