Retention Samples in Clinical Trials
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Do retention samples from clinical studies need to fulfil any special consideration in terms of storage than the commercial drugs? Annex 13 is so general about it. I have consulted some other guidelines (PDA guidelines) but I could not find any information that only applies for clinical trials. Thank you in advance for your support.
Definately send this question to GMP Committee, they know about these sort of requirements
Retention samples should be kept at the testing facility where the study was conducted. Clinical Trials are a great option for people who are not having great luck with current standards of treatment.
GMP Committee response
Annex 13 provides the requirements for IMP reference and retention samples in paragraphs 36/37. It is not clear within you question which elements you are looking for more detailed information on. The annex is not explicit about storage conditions, but these are expected to be in accordance with the product label.
The reference to 2017/1569 is not effective at this present time. It will only be effective once 536/2014 is made effective and is subject to the transition period.