groups » Regulations and Guidelines » Destruction of Investigational Medical Product following Trial Termination.
All clinical trials materials and Investigational Medicinal Products (IPs) that have been used, partially used, or unused but are no longer required for the study including expired clinical trials Investigational medical products, must be reconciled and disposed of appropriately, in accordance with the current guidelines and legal requirements in each country. In general, these procedures must comply with Good Clinical Practice requirements on supply and handling of clinical trials supplies. The destruction of IPs can be done onsite (trial site) or offsite (the sponsor’s designated destruction site). In both cases, the Sponsor must approve the destruction of IPs before the process is ever started.
For offsite destruction, All IPs not dispensed and/or expired, must be stored in a specifically allocated and controlled area not accessible to unauthorised persons. The IPs must be accounted for and kept in the Pharmacy department until these are reconciled by the Sponsor. These will then be ready to be returned to the Sponsor. Any relevant forms such as IP inventory, Acknowledgement of Receipt of IPs and Decoding Envelopes (blind studies) provided by the Sponsor to document the return of the IP should be completed by the responsible member of the trail team and filed within the Pharmacy section of the Study File. The monitor of the study usually makes arrangements for the expedition of the IPs to the destruction site. This usually requires the provision of an importation license into the country of destruction which often is a time consuming and laborious process.
For onsite destruction, processes of reconciliation of study IPs with the sponsor must be through for an approval to be delivered for IP destruction. In some cases, discrepancies must be investigated before this is possible. The process of destruction must comply with the local regulations in force, which for some countries in Africa are usually very stringent. Records on the destruction of the IPs must then be generated. Typically they clearly identify the name of the product, the method of destruction, batch number and expiry dates, Patients numbers involved, and the quantities sent for destruction. In the certificate of destruction, the names and designations of the persons in charge of the procedure of destruction must be mentioned as well as witnesses of the process. In some countries, this may seem straight forward, but in others, it is a long process. In Cameroon for example, the process of IP destruction is not handled entirely by the Department of Pharmacy at the Ministry of Public Health. The Central procurement Pharmacy and the Mayor of the town where destruction is expected to take place are all involved. But the place to begin is the department of pharmacy where note is going to be made of the purpose for destruction, the origin and composition of the IPs and the relevant procedures to be followed explained.
What is your experience? How is the process handled in your country or setting? What do you do with IPs at the end of Clinical Trials? I will like us to share our experiences in both northern and southern countries.
on a different topic: do you have any examples of trial organizational charts? Thanks,
Thanks for your query. Do you mean organisation of the individuals (e.g. structural organisation of staff), or of how the trial itself is organised - e.g. project flow?
The Editorial Team