We previously posted a blog about Investigator Oversight that talked about the responsibility the Investigator has when working on a trial. At a recent site visit, it was discovered that the site had “accidentally” misplaced multiple investigational products. It was a scramble by the sponsor, the CRO, and the site to solve the mystery of “Where did the devices go”? According to 21 CFR 812.110(c), the investigator shall permit an investigational device to be used only with subjects under the investigator’s supervision. If devices are misplaced, how can this regulation be upheld?
As stated in “Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects”, the sponsor AND the investigator must closely monitor the shipping, use, and final disposal of devices to decrease the risk that an investigational device could be improperly dispensed (whether purposely or inadvertently). The investigator must keep complete, current and accurate records of the receipt, use, or disposition of investigational devices (21 CFR 812.140(a)(2)) and these specific requirements are listed in 21 CFR 812.140(a).
The information needed to document records of receipt, use or disposition of a device include:
- Type and quantity of the device
- Dates of its receipt
- Batch number or code mark
- Names of all persons who received, used, or disposed of each device
- Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of
An investigator with proper oversight will know how much of the investigational product is in his/her possession, when it was received, to whom it was dispensed and how it will be disposed of or returned to the sponsor at the end of the investigation. The story above illustrates how lack of oversight can quickly allow investigational devices to be unaccounted for. The best case is that an unaccounted device causes chaos for everyone involved in the study, but the worst case is that an investigational product gets used outside the protocol requirements, which could put a patient at sever risk! Have you had an experience with an investigational device being unaccounted for? How did you prevent a reoccurrence of the situation? We want you to share your experiences.
Photo Credit: Beige Alert