Table 2.

Initiation visit

Discuss Good Clinical Practice guidelines and regulations Check that all relevant regulatory documents are present in the study file Assess that site personnel understand all study procedures, including drug accountability procedures, and ensure that study staff are aware of their roles and responsibilities with regard to the protocol; conduct training as needed Assess that site personnel understand the processes for recognizing, recording, and reporting adverse events and serious adverse events; conduct training as needed Assess that site personnel understand methods for case report forms completion and data submission; conduct training as needed Assess the site's overall readiness to conduct the protocol; e.g., study supplies are in place and facilities are adequate