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.