Bioequivalence and Bioavailability Forum

Dear Pranit!

Hopefully the CRO has an SOP for the storage and destruction of biosamples in place. Generally the length of storage period after submission of the final analytical report should be part of the contract between sponsor and CRO. When I was in a CRO our procedures were as following:

• Storage of biosamples for three months after acceptance of the report by the sponsor.
  
• After three months the sponsor is informed about the planned destruction and possible extended storage up to the validated long-term storage at additional costs.
  
• The sponsor has to agree wth the destruction (signed form).
  
• If samples were destructed, we always kept all samples of one subject with the highest concentrations (clock of degradation ticking!). This was just a security measure to show at least something at an expection (though reanalysis doesn't make sense and was never requested).

❝ If sample discarded, then what will be the regulatory issue?

No idea.
Maybe you take a photograph of the sample set? Include a digital watermark to prevent manipulation of the image.

Dear Pranit,

❝ If sample discarded, then what will be the regulatory issue?

As far as I know: none. I am not aware of any requirement in any of the main BE guidelines (EU, USA, WHO...) requiring the plasma samples to be kept for any period of time once the trial is completed.

The main possible issue is if the re-analysis of the samples is needed once the list of questions is received from the authorities (if they want another analyte, or if problems are identified with the bioanalytical method used). But then you won't have sufficient long-term stability data anyway.

As Helmut says in his answer: make sure the retention period is specified in the contract.

Regards
Ohlbe