Clinical Trials

❘❙❚■ Chapter 3 | Protocol DevelopmentKey components of a trial protocolThe trial protocol is a comprehensive document and the core structure of theprotocol should be adapted according to the type of trial. ICH–GCP canbe used as a reference document when developing a protocol for pharmaceuticalclinical trials (Phase I to Phase IV) involving a pharmaceutical substance (theinvestigational medicinal product [IMP]) [1]. Most institutions and pharmaceuticalcompanies use a standard set of rules to define the main protocol outline,structure, format, and naming/numbering methods for their trials. In this section,we briefly describe the main components of a typical protocol.Protocol information pageThe front page gives the:• trial title• trial identification number• protocol version number• date preparedThe descriptive title of the protocol should be kept as short as possible, but atthe same time it should reflect the design, type of population, and aim of thetrial. ICH–GCP suggests that the title of a pharmaceutical trial should additionallyinclude the medicinal product(s), the nature of the treatment (eg, treatment,prophylaxis, diagnosis, radiosensitizer), any comparator(s) and/or placebo(s),indication, and setting (outpatient or inpatient) [1]. The key investigational site,investigator, and sponsor should also be detailed on the title page.Table of contentsA table of contents is a useful tool that allows easy navigation through theprotocol. The table of contents may vary according to the design of the clinicaltrial. Table 3 gives an example table of contents for a typical protocol.Definition of abbreviationsAll abbreviations used in the protocol should be defined in a separate section.These should be accepted international medical or scientific abbreviations.26