What document is primarily reviewed during a site initiation visit?

During a site initiation visit, the primary focus is on regulatory compliance requirements. This visit is crucial to ensure that the site is prepared to conduct the clinical trial in accordance with all applicable regulations, guidelines, and the study protocol. The initiation visit typically involves a thorough review of essential documents that confirm the site’s readiness, including ensuring that the investigators and study staff understand their responsibilities and the regulatory environment in which they will operate.

Reviewing regulatory compliance requirements includes confirming that all necessary approvals are in place, including Institutional Review Board (IRB) approval and any necessary regulatory agency approvals. Additionally, it involves a discussion about the study's informed consent process, the handling of investigational products, reporting of adverse events, and ensuring that the site is equipped with the necessary Standard Operating Procedures (SOPs) to adhere to Good Clinical Practice (GCP).

While other aspects like previous studies data, patient recruitment strategies, and data management protocols may be relevant to the overall conduct of the study, they are not the primary focus of the site initiation visit in terms of compliance and regulatory preparedness.