FAQs

  Question: I do not understand why artifact [xyz] is included in the TMF Reference Model as there doesn’t seem to be a regulatory requirement for it to be included. Answer: If there is a specific regulatory requirement for an artifact or the general opinion of the TMF Reference Model Community based on past experience is […]

Unanimous opinion across the TMF Reference Model is that draft versions of documents should not be kept in the TMF, including versions with track changes. Key reasons include: Maintaining drafts and annotations can highlight issues that don’t exist such as comments not followed up or opinions not agreed with; There is no obligation to action

Question: We are looking for the best way of standardizing our filing system of documents issued during non-interventional trials (e.g. Post-Marketing Surveillance). These trials are getting more and more structured and require a centralized approval for being conducted in a lot of countries. Do you know whether some guidance exists for structuring a TMF for these

Every artifact that is specifically identified in chapter 8 of ICH GCP has the relevant citation listed. In addition, where text elsewhere in the ICH guideline refers to a trial artifact, that citation has also been listed. For example, ICH section 4.12 discusses the need for the investigator to notify the IRB/IEC of trial termination.

ICH-GCP only uses the word “signed” in relation to 5 TMF documents: protocols and amendments; agreements/contracts; completed consent forms; completed case report forms; and CRF correction signature sheet / signature log. The MHRA have stated in the GCP Guide that “signatures on documents are recommended only where it adds value”. ADDENDUM: Whilst there may be