The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date, no internationally adopted harmonised standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information.
Variability in format and core content among sponsors contributes to inefficiencies and difficulties in searching, reviewing, and assessing clinical trial protocols. Use of the clinical trial protocol template aids the sponsor or sponsor-investigator in the development of a protocol that is complete, free from ambiguity, well organised, and aligned with quality by design principles as set forth in other ICH guidelines. By conveying information consistently and in the same location across clinical trial protocols, a protocol template is intended to provide value to parties that include sponsors, investigators, clinical site personnel, trial participants, ethics committees, and regulators…
