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
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