Certified Clinical Research Coordinator (CCRC) Practice Exam

Which aspect of a trial does the protocol NOT typically include?

1. Design and organization of the trial

2. Details on statistical considerations

3. Financial investment required for the trial

4. Objectives of the trial

The correct answer is: Financial investment required for the trial

The correct answer is that the protocol does not typically include the financial investment required for the trial. In clinical trial protocols, key components are focused on the scientific and operational aspects of the trial. These elements include the design and organization of the trial, which outline how the study will be conducted; details on statistical considerations, which are essential for understanding how data will be analyzed; and objectives of the trial, which define what the study aims to achieve. Financial details, such as the costs involved in conducting the trial, are generally considered part of the administrative and budget considerations that may be discussed in funding proposals or grant applications but do not form a formal part of the trial protocol itself. The protocol serves to guide the execution of the study and communicate essential information to regulatory bodies and participating sites, thus emphasizing scientific rigor rather than financial planning.