protocol
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
- Used For
- trial protocol
- Related Term
- clinical trial
- clinical trial protocol number
- monitoring
- per protocol set
- performed activity
- protocol amendment
- study plan
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