Who are investigators required to submit a final study report to?

Investigators are required to submit a final study report to both sponsors and the Institutional Review Board (IRB) as part of their responsibilities in clinical research. The sponsor, typically a pharmaceutical company or research organization, needs the final report to understand the results and implications of the study, which can inform future research and regulatory filings. The IRB, which oversees the ethical conduct of the research, requires the final report to ensure that the study was conducted ethically and to evaluate any outcomes that may impact participant safety and welfare.

This dual submission ensures that all stakeholders have access to the comprehensive findings from the study, allowing for transparency and accountability in the research process. It also helps in maintaining compliance with regulatory standards and guidelines, which are essential for the integrity of clinical research.

While participants, family members, government agencies, and collaborating investigators may have interest in the study outcomes, the formal requirement for submission lies primarily with the sponsors and the IRB.