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.
Good Clinical Practice 16 Statistics ICH E6: Section 6.9 Statistics section should include: Description of statistical methods for endpoints/outcome measures The number of subjects (and justification) Level of significance used Termination criteria Procedure of accounting for missing, unused and spurious data Plan for reporting deviations from statistical plan
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Good Clinical Practice, ADDENDUM, GOOD, HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE, Good Clinical, Practice, Guideline, Good clinical practice E6R2, Preparing for Certification as a, Clinical, Clinical CAPA: Embedding Quality into Clinical Research, 22800 Federal Register /Vol. 73, 22800 Federal Register/Vol. 73