Retrospective Review. When a FCOI is not identified or managed in a timely manner or when an Investigator fails to comply with a management plan, the DIO, within 120 days of a determination of non- compliance, must complete a retrospective review of the Investigator’s activities and the PHS Award to determine if there was bias in the design, conduct, or reporting of such research. The information that must be documented in the retrospective review is outlined in Appendix C. If bias is found through a retrospective review, the DIO will notify the PHS Awarding Component promptly and submit a mitigation report containing the information outlined in Appendix D. Thereafter, the DIO will submit FCOI reports annually as described in Appendix A.
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Samples: Policy on Conflicts of Interest, Policy on Conflicts of Interest, Policy on Conflicts of Interest
