Risk-Based TMF Health Check

This checklist provides sponsors with a practical way to assess TMF risk across eight key areas: governance, service provider oversight, internal resources and training, study startup, quality review, closeout and archiving, technology, and study-specific risk factors. Aligned with the risk-proportionate principles of ICH E6(R3), it helps teams identify where controls are established and where additional attention may be needed.

By answering each question with Yes, No, or Unsure, organizations can uncover potential gaps, prioritize areas with the greatest inspection exposure, and take action before risks become findings. The checklist supports a more structured approach to TMF quality, oversight, and inspection readiness throughout the full study lifecycle.