Clinical trials should be described in a clear, concise and operationally feasible protocol. The protocol should be designed in such a way as to minimise unnecessary complexity and to mitigate or eliminate important risks to the rights, safety, and well-being of trial participants and the reliability of data.
Protocol development processes should incorporate input from relevant interested parties, where appropriate. Building adaptability into the protocol, for example, by including acceptable ranges for specific protocol provisions, can reduce the number of deviations or in some instances the requirement for a protocol amendment. Such adaptability should not adversely affect participant safety or the scientific validity of the trial. For additional information, refer to ICH E8(R1) General Considerations for
Clinical Studies, ICH E9 Statistical Principles for Clinical Trials and ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials.
The contents of a trial protocol should generally include the following topics, which may vary depending on the trial design. Investigator site-specific information may be provided on separate protocol page(s) or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.