Transcription of Protocols and GCP - ICSSC
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Protocols and GCP - ICSSC
Good Clinical Practice1 Protocols and GCPP rotocols and GCPGood Clinical Practice2 Purpose 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 Practice3 General Information General Information ICH E6: Section E6: Section title, identifying number, version numberand dateGood Clinical Practice4 General InformationGeneral InformationICH E6: Section E6: Section , address of the sponsorSponsor s medical expert for the studyGood Clinical Practice5 Background Information Background Information ICH E6: Section E6: Section with protocol , GCP, and regulatory requirementsGood Clinical Practice6 General 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 Practice7 Background 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
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