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During the site initiation visit, the primary focus is on the protocol and regulatory obligations. This is a critical step in ensuring that all parties involved understand the study's requirements and the regulations governing clinical research. It is during this visit that the research team, including investigators and site staff, reviews the study protocol in detail to ensure that all aspects of the study are clear, including the objectives, study design, eligibility criteria, and the procedures that need to be followed.

Additionally, regulatory obligations are emphasized to ensure compliance with applicable laws and guidelines, such as Good Clinical Practice (GCP) and the ethical treatment of participants. This thorough review helps prevent misunderstandings and sets a solid foundation for the successful execution of the clinical trial. By centering on these elements, the site initiation visit aims to align all parties with the study's goals and requirements, which is essential for maintaining the integrity of the trial and the safety of participants.