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Book: Study site standard operating procedures

TitleStudy site standard operating procedures
Authors
Other Contributors
Issue Date2000
Publisherthe Centre
Citation
Thorburn, J ... (et al). Hong Kong: Clinical Trial Centre, Faculty of Medicine, University of Hong Kong. 2000 How to Cite?
SubjectClinical trials -- Standards -- China
Clinical trials.
Persistent Identifierhttp://hdl.handle.net/10722/54811
ISBN

 

DC FieldValueLanguage
dc.contributor.authorThorburn, J-
dc.contributor.authorTam, SYM-
dc.contributor.authorYan, YSM-
dc.contributor.authorKarlberg, JPE-
dc.contributor.otherUniversity of Hong Kong. Faculty of Medicine. Clinical Trial Centre.en_HK
dc.date.accessioned2009-07-03T04:06:33Z-
dc.date.available2009-07-03T04:06:33Z-
dc.date.issued2000en_HK
dc.identifier.citationThorburn, J ... (et al). Hong Kong: Clinical Trial Centre, Faculty of Medicine, University of Hong Kong. 2000-
dc.identifier.isbn9628540521en_HK
dc.identifier.otherocm45028826en_HK
dc.identifier.urihttp://hdl.handle.net/10722/54811-
dc.description.tableofcontentsIntroduction ven_HK
dc.description.tableofcontentsPre studyen_HK
dc.description.tableofcontentsTrial operationen_HK
dc.description.tableofcontentsStudy closureen_HK
dc.description.tableofcontentsQuality assuranceen_HK
dc.description.tableofcontentsClinical proceduresen_HK
dc.description.tableofcontentsAppendicesen_HK
dc.description.tableofcontentsPreparation of clinical trial protocol and protocol amendments 1en_HK
dc.description.tableofcontentsPre-study visit 9en_HK
dc.description.tableofcontentsReview and validation of clinical trial protocol 14en_HK
dc.description.tableofcontentsReview of protocol amendments 22en_HK
dc.description.tableofcontentsReview of investigators brochure 26en_HK
dc.description.tableofcontentsReview of case report form 31en_HK
dc.description.tableofcontentsContracts and budgets 35en_HK
dc.description.tableofcontentsStudy organisation and planning 40en_HK
dc.description.tableofcontentsStudy team : definition of responsibilities 58en_HK
dc.description.tableofcontentsRecruitment of subjects 62en_HK
dc.description.tableofcontentsPre-study planning of investigational products and devices 68en_HK
dc.description.tableofcontentsPre-study planning for laboratory investigations 73en_HK
dc.description.tableofcontentsIndependent ethics committee or institutional review board 78en_HK
dc.description.tableofcontentsInvestigator meeting and GCP training 86en_HK
dc.description.tableofcontentsPre-study checklist 89en_HK
dc.description.tableofcontentsSite initiation visit 93en_HK
dc.description.tableofcontentsBlinding : codes and code breaking 101en_HK
dc.description.tableofcontentsInvestigational products accounting and dispensing 104en_HK
dc.description.tableofcontentsCase report form completion 110en_HK
dc.description.tableofcontentsObtaining written informed consent 114en_HK
dc.description.tableofcontentsAdverse event and serious adverse event reporting 129en_HK
dc.description.tableofcontentsMonitoring visits 134en_HK
dc.description.tableofcontentsData clarification 139en_HK
dc.description.tableofcontentsStudy closure visit 145en_HK
dc.description.tableofcontentsArchiving of study data 149en_HK
dc.description.tableofcontentsIndependent data monitoring 155en_HK
dc.description.tableofcontentsAudits 158en_HK
dc.description.tableofcontentsInspections 164en_HK
dc.description.tableofcontentsMeasurement of blood pressure 171en_HK
dc.description.tableofcontentsSpirometry testing 175en_HK
dc.description.tableofcontentsMeasurement of body weight and height 178en_HK
dc.description.tableofcontentsVenepuncture (adults) 182en_HK
dc.description.tableofcontentsPreparation and approval of SOPs 187en_HK
dc.description.tableofcontentsFormat for investigators CV 188en_HK
dc.description.tableofcontentsDeclaration of Helsinki 190en_HK
dc.description.tableofcontentsICH GCP E6 guidelines 193en_HK
dc.format.extentv, 248 p. 28 cm.en_HK
dc.format.mimetypeapplication/pdfen_HK
dc.languageengen_HK
dc.publisherthe Centreen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subject.ddc610.72 S93en_HK
dc.subject.lcshClinical trials -- Standards -- Chinaen_HK
dc.subject.lcshClinical trials.en_HK
dc.titleStudy site standard operating proceduresen_HK
dc.typeBooken_HK
dc.identifier.hkulb2165934en_HK
dc.identifier.emailThorburn, J: jthorbur@hkucc.hku.hk-
dc.identifier.emailTam, SYM: ymstam@hkusua.hku.hk-
dc.identifier.emailYan, YSM: ysmyan@hkucc.hku.hk-
dc.identifier.authorityTam, SYM=rp00407-
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.hkuros114189-
dc.identifier.hkuros49794-
dc.identifier.spage1-
dc.identifier.epage248-

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