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Managing Investigational Product Returns from Research Participants

December 23, 2019

FDA 21 CFR 312.57 Recordkeeping and Record Retention requires sponsors to maintain adequate records showing the receipt, shipment, or other disposition of an investigational drug. Included in the disposition of the investigational drug products (IP) is the documentation of IP that is returned from research subjects.

Who is responsible for verifying and documenting investigational product (IP) returns?

Principal investigators or investigator designees (research team member, IDS staff) are responsible for verifying and documenting investigational product returns.

Are there different requirements for return of hazardous investigational products?

Hazardous IP returns should not be counted (measured) by the research team members. These products must be returned to the pharmacy for proper handling of the hazardous IP according to institutional policies and the IP manufacturer’s instructions.

When should IP returns be documented?

IP returns should be documented within the timeframe specified in the protocols or as soon as possible after return from the participant.

How should IP returns be documented?

IP returns should be documented according to the protocol or sponsor specifications. If no instructions exist the following should be documented for the IP: date of return, amount/volume returned, initials of person documenting the return, and other IP specific information if applicable, to identify the IP (bottle/kit#, lot number, etc.)

Where should the documentation be recorded/maintained?

The documentation shall be maintained in Epic, the case report form, or other study specific documentation and available for sponsor and FDA review. Some clinical trials utilize interactive response technology (IRT) to document the returns.

How should participants be educated about IP returns?

During counseling with the research participant, the requirement to return all unused IP and empty containers at the next study visit shall be communicated to the research participant. Pharmacy adds information to the prescription label or IP packaging to indicate that “All unused or empty containers should be returned at the next visit.”

What should the study teams do if a participant fails to return IP?

Participants failing to return unused or empty IP containers should be encouraged to bring containers to their next visit. Failure to return unused or empty IP containers at the study visit or end of the trial must be documented in Epic or in study-specific documentation by the PI or designee.