SOCRA CCRP Practice Exam

What should the Statistics section of the protocol contain?

1. Statistical methods, subject enrollment numbers, and analysis criteria

2. History of the investigational product

3. Marketing plan

4. Biographies of key study staff

The correct answer is: Statistical methods, subject enrollment numbers, and analysis criteria

The Statistics section of a protocol should contain statistical methods, subject enrollment numbers, and analysis criteria. This section is important because it outlines the statistical methods and procedures that will be used in the study, provides information on how many subjects will be enrolled in the study, and defines the criteria that will be used to analyze the data. These aspects are crucial for ensuring the accuracy and reliability of the study results. The other options, such as the history of the investigational product, marketing plan, and biographies of key study staff, are not relevant to the Statistics section and therefore are incorrect. Including them in this section would only add unnecessary information and could potentially confuse or distract from the important statistical information.