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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.
—-Unfortunately, there’s no one answer. One trial can have more than one type of lab (central, country-specific, site, etc.), necessitating different types of “credentialing” records.
Collect the type of records that qualify the lab for that particular trial, and don’t worry about the ones that don’t apply.
As oft repeated at GCP conference last week (MHRA, FDA and Health Canada) – one size does not fit all.
Hi Meredith:
I’ll hazard a guess that your question is about retained samples, and you’re right there’s no individual artifact for a retained sample plan. However, one could logically file such a plan in the “Record of Retained Samples” which is 08.02.05.
If my guess is way off, please add some additional information so we can better support you. Be especially helpful to cite the EU CT reg referenced in your subject line.
Hope this helps! Fran
Great question! Subject Log 05.04.01 is a general “bucket” record to account for the wide variety of trial types the Model serves. So, if the trial protocol or a trial plan dictates the need for any de-identified subject log, 05.04.01 is where it goes.
Please note the another record: Subject Identifying Logs at 05.04.10. These are generally held only at trial site as they usually identify the human trial participants.
As with any Model: “Your use may vary”. If that doesn’t clarify your question, please do let us know!
Fran