Home Forums Where do I file…. ? EU CTR – Compliance with use of Biological samples

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    • #4416

      if this information is not sufficiently covered in the protocol and is provided separately, where should it be filed in the TMF? I can’t find anything exactly suitable in Zone 08. There is no “Sample Management Plan” artifact, which would be ideal. I don’t really want to file it under non-IP Management Plan because it really should be filed in Zone 08; the closest I can get is 08.01.05 Manual. Thoughts?

      Thanks in advance for your help!

    • #4518
      Fran Ross

      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

    • #4524

      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!

    • #4535
      Karen Roy

      The new Clinical Trials Regulation (EU) 536/2014 has raised questions about possible new document types for the TMF and how they might be filed and managed.
      In response to those questions, the TMF Reference Model Steering Group will be holding an all-hands workshop on 7th April at 11am EST / 4pm GMT. At this workshop, we will present an initial view on the documents and possible mappings and to consider any potential impact on the Reference Model. This will then be fed back to the Change Control Board for formal assessment within their Zone teams.
      If you would like to join and actively contribute to these discussions, please pre-register here: https://us06web.zoom.us/meeting/register/tZwrceCpqTMiHtKDA-k4A_bydzUOvAPpSd_h. After registering, you will receive a confirmation email containing information about joining the meeting.
      IMPORTANT NOTE: This workshop is intended solely for participants who will actively contribute thoughts and opinions. Please do not register simply to listen in. Thank you!

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