|Trial protocol / study protocol
|The trial protocol, also known as the study protocol or the test protocol, is the basis of every clinical trial. In includes detailed information on the conduct of the study. ICH-GCP section 6 lists the obligatory contents of a trial protocol. Some of the most essential elements are listed here:
The trial protocol must be approved by the corresponding higher federal authority and given a favourable opinion by the ethics committee before starting a clinical trial. Essential changes to the trial protocol that occur after the start of the clinical trial, known as substantial amendments, must be approved by the aforementioned institutions.