Answer: Investigators sponsors and IRBs
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The ICH E6 GCP describes standards that apply to what?
Adults with more than 12 months history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X or placebo . The primary efficacy measure was the reduction in the severity of the migraine attacks . Enrollment was 1200 subjects.
Set standards for the design conduct monitoring and reporting of clinical research. The ICH E6 GCP describes standards that apply to: Investigators sponsors and IRBs .
Set standards for the design conduct monitoring and reporting of clinical research. The ICH E6 GCP describes standards that apply to: Investigators sponsors and IRBs .
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ICH-E6 Protocol: States the “objectives design methodology statistical considerations and organization of a trial .” “Usually gives the background and rationale for the trial.” In ICH-E6 protocol refers to both protocol and protocol amendments . 20 …
The GCP ICH Basic course covers International Council for Harmonisation ...
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