Protocols and GCP - ICSSC

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Good Clinical Practice1Protocols and GCPProtocols and GCPGood Clinical Practice2Purpose of ProtocolPurpose of ProtocolClear and complete description of rationale, methods, and analysisGives us the details before research beginsAllows us to decide if the research isethical, relevant, and Clinical Practice3General Information General Information ICH E6: Section E6: Section title, identifying number, version numberand dateGood Clinical Practice4General InformationGeneral InformationICH E6: Section E6: Section , address of the sponsorSponsor s medical expert for the studyGood Clinical Practice5Background Information Background Information ICH E6: Section E6: Section with protocol , GCP, and regulatory requirementsGood Clinical Practice6General InformationGeneral InformationICH E6: Section E6: Section Address, telephone of study site Include names and addresses of labs, data management, statistician, etc. Investigator responsible for the studyGood Clinical Practice7Background InformationBackground InformationICH E6: Section E6: Section of findings from nonclinical and clinical studiesBrief description of study product or interventionPotential risks and benefits to participantsWhy is study needed?

Good Clinical Practice 2 Purpose of Protocol Clear and complete description of rationale, methods, and analysis Gives us the details before research

  Protocol, Protocols and gcp