Interim or annual reports are provided to which parties?

• A. Sponsor only
• B. IRB/IEC and Authorities
• C. Investigators only
• D. Subjects

Answer: (B)

Interim or annual reports are meant for independent oversight bodies that monitor ongoing trials. These reports summarize trial progress, safety data, protocol amendments, and any issues affecting risk/benefit. They are provided to the IRB/IEC to ensure ongoing ethical review and participant protection, and to regulatory authorities to satisfy oversight and regulatory requirements. They aren’t primarily sent to sponsors, investigators, or subjects as the main recipients—the IRB/IEC and authorities are the ones responsible for ongoing monitoring of the trial’s safety and conduct.