Module 12 2019

What is the TMF?

• The TMF is a collection of records that tells the story of a clinical trial • A properly maintained TMF ensures all actions that occurred and decisions that were made during the trial can be reconstructed • Ensures audit and inspection-readiness at all times, but also allows regulatory authorities to evaluate the quality and integrity of the trial data

• The TMF should be a stand- alone set of records

The Organisation for Professionals in Regulatory Affairs