If you received word that your organization will be subject to a regulatory inspection of your TMF, how would you react?

Would you feel confident in the current state of your TMF? Would you be concerned that you're not ready to be inspected?

Wherever you think you'd fall on this spectrum, our checklist will provide you with a clear action plan as you plan for your TMF inspection:

  • Coordinate with the health authority
  • Start planning your inspection
  • Prepare your trial master file
  • Coordinate inspection logistics
  • Prepare the system
  • Ready inspector access
  • Make copies of documents
  • Provide access to outside systems
  • Conduct inspector training

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