Jacqui Kerr - How Clinical Trials Site Initiation Visits work and why they matter
April 8, 2026·6 min
Jacqui Kerr introduces herself as the Network Manager of the Neuro-Progressive and Dementia Network in Scotland. She states the episode will cover how site initiation visits work and why they matter. Kerr explains that SIVs occur after a clinical study receives approval and marks the shift from planning to real-world delivery. She describes SIVs as the true launch point of a study, ensuring site readiness for activation. Kerr notes that SIVs are sometimes seen as routine meetings but play a crucial role in preparing sites for safe and consistent study conduct. She defines a site initiation visit as occurring only after site selection and completion of regulatory agreements. The purpose is to confirm site preparation before participant approach, screening, or enrollment. SIVs are typically led by the study sponsor, clinical research associate, or study monitor. They include protocol training where the CRA guides the team through inclusion/exclusion criteria, visit schedules, assessments, endpoints, and safety monitoring. Role delegation is discussed, with the team reviewing delegation logs to assign tasks like obtaining informed consent, data entry, and adverse event reporting. Regulatory and documentation reviews ensure all approvals are in place and the investigator site file contains essential documents. Data management sessions cover source documentation, database entry, error handling, and monitoring plans. For drug studies, pharmacy sessions address storage requirements, temperature monitoring, accountability procedures, dispensing processes, and medication handling. Kerr concludes that SIVs require collaboration and clear communication, equipping teams with knowledge and tools for successful study delivery.
