CITI GCP Practice Exam – Complete Study Resource 2026

The responsibility for the annual reporting of an Investigational New Drug (IND) application to the FDA falls on the sponsor-investigator. The sponsor-investigator is the individual who both initiates and conducts an investigation and is responsible for ensuring compliance with regulatory requirements. This role includes the obligation to submit annual reports to the FDA that summarize the progress of the clinical investigation, provide information on the safety of the drug under investigation, and report any significant findings that may affect the conduct of the study or the welfare of study participants.

In this context, the other options are less relevant in terms of accountability for the reporting. Study participants do not have roles in regulatory submissions, as their engagement is strictly in providing data or outcomes related to the trial. Research institutions may facilitate the administration and oversight of clinical trials but do not directly report to the FDA. Finally, while the FDA oversees and reviews these reports, it is not responsible for compiling or submitting them; rather, it is the responsibility of the sponsor-investigator to provide that information. Thus, the correct answer reflects the regulatory framework that designates the sponsor-investigator as the responsible party for this crucial aspect of maintaining compliance with IND regulations.