When the sponsor discontinues clinical development of an investigational product, who should be notified?

• A. Investigators and Institutions
• B. Regulatory Authorities
• C. Both Investigators/Institutions and Regulatory Authorities
• D. The Sponsor

Answer: (C)

When a sponsor discontinues development of an investigational product, both the investigators/institutions conducting the trial and the regulatory authorities must be informed. Investigators and sites rely on timely notice to protect participants, manage ongoing safety responsibilities, and adjust trial activities (such as stopping enrollment or modifying monitoring). Regulatory authorities need to be informed per regulatory requirements to maintain oversight, update records, and address any reporting or compliance obligations. Notifying only one group would leave others uninformed and could compromise participant safety or regulatory compliance. The sponsor has the duty to communicate with both parties, not to act alone in isolation.