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

The sponsor-monitor should conduct the most detailed review of the study protocol with the site's study staff during the site initiation visit. The site initiation visit is a crucial step in the start-up phase of a clinical trial. During this visit, the sponsor-monitor provides detailed information about the study protocol, procedures, and regulatory requirements to the site's study staff.

Key activities during the site initiation visit include:

1. Protocol Review:

• The sponsor-monitor thoroughly reviews the study protocol with the site's study staff.
• Detailed discussions about the inclusion and exclusion criteria, study endpoints, and other critical protocol elements take place.

2 Regulatory Requirements:

• The sponsor-monitor ensures that the site's study staff understands and complies with all regulatory requirements relevant to the study.

3 Study Procedures:

• Detailed explanations of study procedures, data collection methods, and the proper conduct of the trial are provided.

4 Training:

• Training on the use of any specific equipment or procedures unique to the study is conducted.

5 Question and Answer Session:

• The site's study staff has the opportunity to ask questions and seek clarifications regarding any aspect of the study.

By conducting a detailed review during the site initiation visit, the sponsor-monitor helps ensure that the site is well-prepared to conduct the study according to the protocol, regulatory standards, and good clinical practice (GCP) guidelines. This proactive approach supports the successful implementation of the clinical trial.