How often must site visits occur to maintain study compliance?

The frequency of site visits is determined by the study protocol, which is a comprehensive plan that outlines the methodology, objectives, and processes for the clinical trial. The protocol may specify how often monitoring visits should take place to ensure compliance with regulatory requirements and to address the oversight of participant safety, data integrity, and adherence to the stipulations set forth in the protocol. This ensures that the study is conducted consistently and that any issues can be identified and resolved promptly.

The other options offer arbitrary timeframes that do not account for the specific needs and requirements of each individual study as laid out in its protocol. The protocol is designed based on various factors, such as the type of study, its complexity, the number of subjects, and the potential risks involved, making it critical to adhere strictly to what is outlined in that document for effective monitoring and compliance.