TMF – Studies not under the IND or CTA

[Alonso Blanco]

is a TMF required for studies not under the IND or CTA? This is part of a compassionate use program which does not fall into the study category and is likely exempt.

[Eldin Rammell]

There is usually a requirement to retain study-specific records for any type of clinical study, including those that are not regulated by Good Clinical Practice requirements (and therefore, not specific TMF requirements). So the set of documents are likely to be much smaller than for an IND/CTA clinical trial and it may not be referred to a “a TMF”, but you’ll still need to retain documentary evidence of what you have done. The TMF Reference Model Project has a sub-team that is developing a reduced Reference Model for this type of study, with many of the artifacts being advisory in the absence of specific global regulatory requirements.

[Rebecca Reyna]

Hello Eldin,

Is the above mentioned reduced Reference Model for IND exempt studies available at this time?

Thanks!

[Alonso Blanco]

Thank you Eldin, your input is highly appreciated.

[Fran Ross]

Lightly edited query below from an industry colleague. How timely is this discussion!

Thanks for the insights Eldin. Be great to have the topic discussed at a TMF RM meeting. For the subgroup, beyond recommendations for reduced TMF RM record types, it might be helpful to include a “TMF or not” decision tree.

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I have a question about Expanded Access Program (EAP) set up in TMF and am unable to find any information about the TMF specifics for such programs.

In this EAP, a 1572 form is used, and there’s cross-reporting records for Safety.

Not successful finding EAP TMF info in public domain and eTMF system build is on hold pending more info.
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