Protocol
The detailed plan that describes how a clinical trial will be conducted.
What it means
A clinical trial protocol is the document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. It is translated into local languages for regulator and ethics committee review in every country where the trial is conducted. Consistency between the protocol, informed consent, and investigator brochure is essential.
Why it matters for LATAM submissions
The protocol is the governing document for a trial. If a translation deviates from the source, the consent form, case report forms, and regulatory correspondence can fall out of alignment.
Relevant regulators
Related terms
Translating this concept for a submission?
Send one document to Amavita and we'll return it with the correct terminology, certification, and formatting for the regulator you're targeting. No charge, no commitment.
Start your LATAM pilot