As per ICH-GCP Guidelines, Protocol is “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.”

 

Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol.