Accountability and destruction
Accountability and destruction of investigational products
Managing investigational products from receipt to final destruction is a critical part of clinical trial supply solution. Every unit must be tracked, reconciled, and securely destroyed once a trial is complete. Without robust accountability and destruction processes, sponsors risk compliance issues, regulatory delays, and unnecessary costs. At KLIFO, we ensure that investigational medicinal products (IMPs) are managed transparently, from first patient visit until certified destruction, supporting regulatory approval and protecting patient safety.
Why accountability matters
Accountability of products used in clinical trials is a regulatory requirement. It ensures that every dose supplied for a clinical trial can be accounted for. Whether dispensed to a patient, returned by the patient to the clinical site, retained unused at packaging facilities, clinical sites or distribution depots, the fate of every dose must be is fully documented. Clear and complete records provide:
- Regulatory compliance – fulfilling FDA, EMA, and ICH requirements
- Data integrity – audit trails that prove accuracy of trial results
- Risk mitigation – preventing unauthorized use of unlicensed products
- Operational efficiency – missing accountability records can delay trial close-out
At KLIFO, accountability is not just a regulatory obligation; we do not consider any project to be truly closed until final accountability and destruction is complete.
Secure and certified destruction
Once a trial concludes, leftover or returned medication must be destroyed in line with strict regulatory and environmental standards. Destruction cannot happen prematurely or without sponsor approval, and it must be fully documented.
KLIFO provides:
- Certified destruction by our approved vendor for our EU facility, and across our depot network by local vendors qualified by our depot partners
- Protocol-specific accountability and destruction processes
- Prompt turnaround of destruction following client approval of final inventory records, avoiding costly long term storage of unused and returned clinical supplies.
- Qualified partner meets EU Environmental standards
Typical deliverables
When working with KLIFO, sponsors receive:
- Comprehensive accountability logs
- Verified reconciliation of returned products
- Final inventory reports for approval prior to destruction
- Prompt receipt of Certificates of Destruction from approved disposal facilities
Common client challenges
Many sponsors underestimate the complexity of returns and destruction, especially for late phase trials. Without expert management, they risk:
- Missing or inconsistent accountability records delaying trial closure
- Excess storage fees for unused products retained beyond approval to destroy
- Site frustration due to limited storage space for returns
- Regulatory queries caused by poor documentation
KLIFO’s structured process eliminates these risks and ensures a compliant, cost-effective outcome.
Guidance through every phase
As trials expand, returns management becomes more complex. In many cases, it follows a decentralised model with local facilities being employed in many countries either for economic reasons, or because some countries will not allow re-export of materials, especially expired materials. While the fate of returned and unused clinical trial materials is not usually a priority when setting up a clinical trial, it should not be overlooked. An experienced CTS partner like KLIFO can help reduce the burden of this activity on Sponsors.
Why choose KLIFO
At KLIFO, accountability and destruction is not just a checklist item—it is a critical safeguard in the clinical trial lifecycle. Our clients value our ability to:
- Keep trials audit-ready at all times
- Deliver reliable documentation for regulatory submissions
- Manage returns and destruction across multiple geographies
- Provide peace of mind that every investigational product is tracked and disposed of correctly
With KLIFO, sponsors gain a trusted partner who ensures that investigational products are managed responsibly from start to finish.
This is outsourced to an approved vendor. KLIFO is transparent about who we use and will provide details of all subcontractors on request.
For EU trials, this is our standard approach. The exception to this is returns from clinical sites in Italy, where we usually recommend use of a depot. Italy does not allow expired medication to be shipped outside of the country, so unless we are confident that all returned drug has sufficient shelf life remaining to allow shipment to our facility in Demark, we always plan on use of a depot in Italy to manage returns, accountability and destruction.
For global trials we recommend use of in-country depots for accountability and destruction. Shipping material that may be worthless back to Denmark, for example from clinical sites in Australia, can get very expensive and creates additional work for clinical sites. As a result, when assessing depot capabilities KLIFO will always ensure that our depot partners are capable of supporting accountability and destruction.
This varies by client and by protocol, but the vast majority of accountability we perform is to shipper level. Since detailed accountability is usually performed at the clinical site, most clients do not ask KLIFO to repeat this, and simply request that if the site shipped returned materials back to us, that these were received and shippers were intact.
Occasionally, clients will ask us to perform more detailed accountability to kit or unit dose level. We have even been asked to weigh part-used unit doses (e.g. tubes of a topical cream formulation) to verify how much of a dose had been used! KLIFO may also be requested to perform more detailed accountability if site records are lost, or if there are discrepancies in records, to verify work performed at clinical sites.
As with all CTS providers, in most cases, the answer to this is ‘no’. KLIFO is unable to guarantee product was adequately stored or handled while in the custody of clinical sites, so cannot be confident of the integrity of any returned products. If requested before a project starts and sufficiently robust processes and responsibilities are established between KLIFO, the Sponsor and clinical sites this may be considered but it is extremely rare that any CTS provider will agree to this approach.
