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Thread: Dispensed expired investigational product to subject.

  1. #1
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    Post Dispensed expired investigational product to subject.

    Site has Dispensed expired investigational product to subject. What would be monitor's responsibilities to resolve the issue?

  2. #2
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    Quote Originally Posted by Bgogoi View Post
    Site has Dispensed expired investigational product to subject. What would be monitor's responsibilities to resolve the issue?
    In my opinion, it should not be the monitor's job to "resolve the issue"; IMP handling at site is the responsibility of the PI (or appropriately delegated staff, e.g., pharmacist). The monitor should promptly report the issue to the Sponsor and train the site so this does not happen again.

    With regards to managing this noncompliance, in my experience best practice would be to report this immediately to:

    • The Medical Monitor, for an immediate (documented) review of any potential safety concerns with the subject who was dosed with the medication. This should include any appropriate medical follow up, as necessary.
    • Clinical Supplies (and hence GMP-QA), for an assessment on the expiry date (to check if there is extended expiry data available, for example, through ongoing stability studies)
    • Study Team, to ensure this is not a systemic issue
    • GCP-QA, for investigation and management through CAPA


    Consideration should also be made regarding the local requirements for reporting this to the Independent Ethics Committee/Institutional Review Board and whether the incident reaches the level of reporting to the Regulators as a Serious Breach of GCP, in accordance with the Sponsor policies on assessing and reporting such.

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