published_or_final_versionICH GCP E6 guidelines 193Clinical proceduresAppendicesPreparation of clinical trial protocol and protocol amendments 1Quality assurancePre-study visit 9Study closureTrial operationReview and validation of clinical trial protocol 14Introduction vReview of protocol amendments 22Review of investigators brochure 26Review of case report form 31Contracts and budgets 35Study organisation and planning 40Study team : definition of responsibilities 58Pre studyRecruitment of subjects 62Pre-study planning of investigational products and devices 68Pre-study planning for laboratory investigations 73Independent ethics committee or institutional review board 78Investigator meeting and GCP training 86Pre-study checklist 89Site initiation visit 93Blinding : codes and code breaking 101Investigational products accounting and dispensing 104Case report form completion 110Obtaining written informed consent 114Adverse event and serious adverse event reporting 129Monitoring visits 134Data clarification 139Study closure visit 145Archiving of study data 149Independent data monitoring 155Audits 158Inspections 164Measurement of blood pressure 171Spirometry testing 175Measurement of body weight and height 178Venepuncture (adults) 182Preparation and approval of SOPs 187Format for investigators CV 188Declaration of Helsinki 19
