01632nam 2200433Ia 450 991069897690332120090618160708.0(CKB)5470000002398104(OCoLC)402677963(EXLCZ)99547000000239810420090618d2005 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierRevision of the ICH guideline on clinical safety data management[electronic resource] data elements for transmission of individual case safety reports[Rockville, MD] :[Center for Drug Evaluation and Research]:[Center for Biologics Evaluation and Research],[2005]25 pages digital, PDF fileTitle from PDF title page (viewed on June 18, 2009)."ICH harmonised tripartite guideline"."Version 2.0"."12 May 2005".Revision of the ICH guideline on clinical safety data management Clinical pharmacologyClinical trialsReportingDrugsTestingClinical pharmacology.Clinical trialsReporting.DrugsTesting.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOBOOK9910698976903321Revision of the ICH guideline on clinical safety data management3448817UNINA