Reply To: EU CTR – Compliance with use of Biological samples

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March 8, 2022 at 10:09 am #4524
Meredith Lafond-Phesans
Participant

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!