Written procedures for handling the investigational product should include which of the following?

• A. Budget approval process
• B. Instructions for dispensing, retrieval of unused product from subjects, and return of unused IP to sponsor
• C. Monitoring plan for data quality
• D. Publication policy

Answer: (B)

Managing the investigational product requires written procedures that cover how the IP is dispensed to subjects, how unused IP is retrieved from subjects, and how any unused IP is returned to the sponsor. These steps ensure accurate inventory, accountability, and traceability, prevent loss or diversion, and help protect participant safety and data integrity. Procedures should also address storage conditions, labeling, and documentation, but the essential elements focus on dispensing, retrieval, and return to the sponsor. Other items like budget approval, data quality monitoring, or publication policy relate to different aspects of the study and not to the handling of the IP itself.