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Hello, we file destruction documentation for non-IP under 06.05.03 Non-IP Return Documentation.
Note: our interpretation of non-IP is anything provided by the sponsor that is not medication, like trial “supplies”. If it is medication provided during the study, whether it is the IP or not, we file it under the same artifacts as IP.Hello,
we interpret Zone 06 to include any product administered as part of the study. This work in vaccines studies, but may be more complicated for drug studies?I hope others will chime in to help!
Hi Fran,
Sorry for the lack of information!
It’s REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT, Article 7 (h): compliance with the applicable rules for the collection, storage and future use of biological samples of the subject.The proposed template for when this information is not sufficiently covered in other documents is this one: https://ec.europa.eu/health/system/files/2022-01/mp_compliance-app-rules-bio_en.pdf.
It ‘s not just about retained samples: you have to describe what samples are being taken, number, volume, etc.; whether archived samples with be analysed; use, storage, transfer; consenting process.
Thanks for any help you can give!
Hello, we have not yet addressed this to be honest. It’s six of one, half a dozen of the other – there’s no right answer, only the one that best suits the kind of TMF system you have, the filing responsibilities in your company, and other factors. In our case (this is a personal opinion again we have not discussed in my company) I might be tempted to file it both Zones 03 and 04, so that our automatic completeness tracking tool is accurate. Yes, it is technically content duplication, but for my part, given the limitations of our eTMF system, content duplication if it serves distinct, separate documentation purposes, is acceptable. I am very open to dissenting opinions!