Protocol (study protocol)

In EU device investigations the equivalent document is the clinical investigation plan, and for IVDs the performance study plan. Changes to the protocol after approval need review, and often approval, before they take effect.

A study plan on which the clinical study is based. A protocol describes, for example, what types of people may participate in the study, the schedule of tests, procedures, medications, and dosages; and the length of the study.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary