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]
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.
Note
Title from PDF title page (viewed on May 28, 2009).
