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Elvin Thalund

Dear Mai,

First, the core purpose of a TMF is to document GCP compliance, so only document content that are for GCP compliance. In traditional trials there have been specific artifacts to document compliance, whereas newer trial designs, such as DCT’s are reliant on risk management to ensure and document GCP compliance.

So, what I would do is to start with documenting the identified risks in artifact 01.01.16 – Risk Management Plan and based on that include the plan for mitigations in artifact 01.01.02 – Trial Management Plan, where you can document what you intent to do and that you have done it.

The actual material be documented in a risk log (sub-artifact) under artifact 01.01.16 – Risk Management Plan. You could also document this under 01.05.02 – Tracking Information and 01.05.03 – Other Meeting Material.

I like to keep related content together in one artifact in this case artifact 01.01.16 – Risk Management Plan, but it all comes down to you being able to answer inspectors questions the best when you need to.

Best regards,