12/17/2020
The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.
New Question 8 (added with other questions moved down): How can the sponsor ensure proper disposal of unused investigational drug product if the participant cannot return to the study site?
Answer summary: It is a regulatory responsibility for the sponsor to ensure return of unused IP from the investigator, although alternative methods are permitted as long as the method does not increase risk of exposure to non-participants. Requirements to follow the regulations have not changed due to the pandemic. The study participant can mail the unused IP back in a prepaid package where it can be documented and disposed per protocol. It should be determined if it is feasible and permissible based on the type of IP; for example, controlled substances require additional safeguards and may not be able to be returned in this manner. If destruction or disposal of IP is required at the participant’s home, it could be documented through video or photos. The method chosen for destruction or disposal should take into consideration safety of others. The FDA offers recommendations for appropriate disposal methods. Note that IP are not permitted to be flushed. Although the investigator may recommend the method of disposition, the sponsor needs to approve it. Any method chosen requires accurate documentation.
As the pandemic continues, additional clarifications may be required. Follow our blog to keep up to date on the latest.
-The Clinical Pathways Team
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