Good clinical practice guide

Autor Medicines and Healthcare products Regulatory Agency

en Limba Engleză Paperback – 24 sep 2012

TheGoodClinicalPracticeGuideisabrandnewpublicationcoveringthelegislation,guidanceandgoodpracticethatrelatestotheconductofclinicaltrialsofmedicinalproductsforhumanuseintheUK.Detailedandauthoritative,thisguidewillprovidepracticaladviceaboutimplementingtheprinciplesofGoodClinicalPracticewithinthecontextoftheclinicaltrialregulatoryframeworkintheEuropeanUnion.WrittenandproducedbytheMHRA,thisistheonlyguideonGoodClinicalPracticeavailablewithinEuropewhichhasbeenproducedbyaregulatoryagency.Thistitleisaimedatanyindividualand/ororganisationinvolvedinconductingclinicaltrialswithmedicinesintheUK,includingbothcommercialandnon-commercialsponsorsandhostsofclinicaltrials,aswellascontractresearchorganisations,clinicalresearchconsultantsandothernicheproviders.TheguidereferencesEuropeanlegislationandguidanceaswellasinternationalstandards,sowillalsoberelevanttoorganisationsconductingtrialsacrossEuropeandbeyond

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