ABSTRACT
During the study initiation period, the site is formally trained in the performance of the study as outlined in the protocol. At this time, the teaching skills of the Clinical Research Associate (CRA) are most critical. The CRA instructs the site staff in the intricacies of the protocol and Case Report Form (CRF) completion, ensuring that the Clinical Research Coordinator (CRC) and other site staff have a clear understanding of the expectations of the sponsor regarding each data entry on each form. The site training can be done either individually by the site’s CRA or in a group setting during an investigators’ meeting.
