Protocol
In Documents & records
Also known as: study protocol, clinical trial protocol
The protocol is the master plan for a clinical trial. It states the objectives, who can take part, what will be done to participants and when, how safety will be handled, and how the results will be analyzed. Every site runs the same protocol, and any departure from it is a protocol deviation.
Why it matters
The protocol is the reference point for nearly every decision on a trial. "What does the protocol say?" is the most useful question a new team member can learn to ask.
Example
Before enrolling anyone, a site team reads the protocol to build its visit schedule: which assessments happen at screening, what the visit windows are, and which laboratory samples go to a central laboratory.
Common questions
- Can a protocol be changed once a trial has started?
- Yes, through a formal protocol amendment. A substantial amendment must be approved by the ethics committee, and usually the regulatory authority, before it is implemented \u2014 except where an immediate change is needed to remove a hazard to participants.
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