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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.

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.