Distilling the Essence of the Protocol: The Protocol Synopsis

The main objective is to get the preparatory phase of the trial, especially protocol feasibility, up and running as rapidly and efficiently as possible. The protocol synopsis is the most important document for ensuring a successful trial. It comprises all the elements essential for planning and carrying out a clinical trial, and is quicker to write, easier to read, less likely to have inconsistencies, and much easier to modify than a full protocol. A protocol synopsis is usually between five and seven pages long, whereas a typical protocol can run from 60 pages (rarely fewer) to 100 pages (sometimes more). The synopsis is therefore the ideal document to use for all the early preparatory activities, as the full protocol adds no value for planning and operational purposes. A fairly typical protocol synopsis template is shown in the appendix at the end of this chapter. The first step is to get an approved draft protocol synopsis. This version of the synopsis should be as complete as possible in every respect, except for those changes that will need to be made as a result of feasibility testing. It is, in effect, the penultimate version of the core of the final protocol. It should go through as many iterations as needed until it reaches the stage at which it can be approved, pending feasibility. At this stage, all aspects relating to the objectives, design, endpoints, investigations, lab tests, and treatment and procedural schedules should be final; otherwise, doing feasibility is a waste of time. This chapter describes how to get to the approved draft protocol synopsis. There are then two more steps that will be described in detail in the following chapters. The second step is the approved protocol synopsis. The draft synopsis has been amended as needed to ensure optimal feasibility without diminishing the validity of the study and has been approved. At this stage, the protocol is, in effect, locked and ready to be implemented.