Training and Supervision Checklist for Sponsor Investigators

Training

General overview of protocol
Specific details of the protocol relevant to tasks designee will be performing
Regulatory requirements and acceptable standards for conduct of clinical trials and human subjects protections
Study staff informed of any pertinent changes during the conduct of the trial and additional training as needed

Review/correct any problems identified by study personnel, monitors, auditors or others
Review delegated tasks to ensure they have been performed satisfactorily
Review consent process to ensure it is being conducted in accordance with federal regulations, that subjects understand the nature of their participation, risks, etc.
Ensure information in the source documents is accurately captured on case report forms
Ensure data queries and discrepancies are dealt with
Ensure study staff comply with the protocol