Human Research Protection Program

HITECH Act

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

Supervision

  • 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