LEADER 01545oam 2200385Ia 450 001 9910698827203321 005 20090915154040.0 035 $a(CKB)5470000002397596 035 $a(OCoLC)355390908 035 $a(EXLCZ)995470000002397596 100 $a20090528d2001 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for clinical trial sponsors$b[electronic resource] $eon the establishment and operation of clinical trial data monitoring committees 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Drug Evaluation and Research :$cCenter for Devices and Radiological Health,$d[2001] 215 $aii, 23 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 28, 2009). 300 $a"Draft guidance". 300 $a"November 2001". 517 $aGuidance for clinical trial sponsors 606 $aClinical trials$xGovernment policy$zUnited States 615 0$aClinical trials$xGovernment policy 712 02$aCenter for Biologics Evaluation and Research (U.S.) 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Devices and Radiological Health (U.S.) 801 0$bGPO 801 1$bGPO 801 2$bGPO 906 $aBOOK 912 $a9910698827203321 996 $aGuidance for clinical trial sponsors$93509397 997 $aUNINA