Asked by michelle
According to ICH GCP (International Council for Harmonization – Good Clinical Practice) guidelines, which document outlines the objective(s), design, methodology, statistical considerations, and organization of a clinical trial?
Informed Consent Form
Investigator's Brochure
Clinical Study Protocol
Case Report Form
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Clinical Study Protocol
Per ICH GCP (E6), the protocol is defined as "a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial."
Per ICH GCP (E6), the protocol is defined as "a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial."
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