CITI Training Practice Exam

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?

1. After the final participant has been enrolled

2. Site initiation visit

3. During the closure visit

4. At the half-way point of the study

The correct answer is: Site initiation visit

The sponsor-monitor should conduct the most detailed review of the study protocol with the site's study staff during the site initiation visit. This is because the site initiation visit is the first formal meeting between the sponsor-monitor and the site staff, and it is important to review the study protocol in detail at the beginning of the study. Reviewing the protocol at this stage ensures that the site staff fully understand the study procedures and requirements, reducing the risk of errors or protocol deviations in the future. The other options are incorrect because after the final participant has been enrolled, the study is already nearing completion and it would be too late to conduct a detailed review of the protocol. During the closure visit, the study is ending and there is no need for a detailed protocol review at this point. Lastly, conducting a detailed review of the protocol at the half-way point of the study may not be as effective in preventing errors since