The sponsor should maintain records for which activities related to the investigational product's lifecycle?

• A. Dispensing, retrieval of unused product from subjects, and disposition of unused IP and documentation
• B. Maintaining staff rosters
• C. Tracking market share
• D. Publish results

Answer: (A)

Managing records for the investigational product's lifecycle focuses on accountability and traceability of the IP from dispensing to final disposition. The sponsor must keep documentation of when and to whom the IP is dispensed, including quantities and lot numbers, so there is a clear audit trail. It also includes records of any unused IP retrieved from subjects, ensuring that what was issued is accounted for, and records of how unused IP is disposed of or returned, with appropriate destruction or transfer details. This complete set of records ensures the IP doesn’t get misused, is properly tracked across the study, and compliance with regulatory requirements is demonstrated.

Staff rosters, market share tracking, and publishing results do not pertain to the lifecycle records of the investigational product. They are administrative or business activities (staffing, market analysis, and dissemination of study findings) rather than the IP accountability and disposition documentation required by GCP.