Reference Model Training Now Available
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 …
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 …
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” …
A ‘not-required’ artifact is shown as core. Why? Read More »
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 …
When is the next TMF Reference Model General Meeting? Read More »
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 …
Why are there gaps in the artifact number sequences? Read More »
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 …
Is the TMF Reference Model applicable to the investigator site file / regulatory binder? Read More »
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 …
When is the next update to the TMF Reference Model due? Read More »
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 …
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” …
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: …
I do not understand why artifact [xyz] is included in the TMF Reference Model Read More »
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 …
Should draft documents be filed in the Trial Master File? Read More »