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

[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