FAQs

A two-part training program for the TMF Reference Model has now been made available. This can be viewed free of charge from the RESOURCES page of this website. The first part covers the background history of the Reference Model, right up to its current status (June 2022). The second part covers: the components of the […]

You may notice that for artifacts 05.04.10 Subject ID Log and 05.04.11 Source Data there is no requirement for them to be in the sponsor TMF, as shown by “NO” in column N and column P of the Reference Model. But in column W, the artifact is shown as a site-level document. This may seem

We try to send meeting notifications to all of our different groups so that everyone who is interested has the most up-to-date information about our meetings. We send a mailing to subscribers, we post to the project team members via groups.io and we post to the Yahoo!Groups discussion forum. However, if you somehow missed these

As you look down the list of numbered artifacts, you may notice a few gaps. For example, in v3.1 of the TMF Reference Model there is a gap between artifact 05.02.14 and 05.02.17. Where is 05.02.15 and 05.02.16? In this example, the two “missing” artifacts were included in an earlier version of the Reference Model

The TMF Reference Model is intended to cover the full scope of the Trial Master File as described in ICH E6 Good Clinical Practice Guidelines. ICH E6 GCP Guidelines include all the content that the sponsor is required to maintain in the sponsor TMF and all the content that the investigator is required to maintain

Change requests for the TMF Reference Model are being submitted on an ongoing basis via the website. In addition, some of our project initiatives produce deliverables that result in additional content to the Model. It is the responsibility of the Change Control Board to make an impact assessment of these changes to determine if they

Question: According to the TMF Reference Model, the master Informed Consent Form should be filed as artifact 02.02.03 but I’m not sure where a site-specific ICF should be filed. As this is a site document, should it be filed somewhere in zone 5? Answer: Several artifacts can be filed at multiple levels: study, country and/or

Question: It appears that “acknowledgement of receipt” is now specifically noted as a sub-artifact under IRB or IEC Submission, while “documentation received from the IRB/IEC in response to submission indicating acknowledgement” remains within the definition of IRB or IEC Approval. Can you confirm and clarify any intended distinction? Answer: An Acknowledgement of Receipt in 4.1.1 is

  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