REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE REPORT CONTENT REQUIRED WHEN? New FCOI Report (Initial Grant Number, PI, Name of Prior to expenditure of submission Entity with FCOI, Nature of funds FCOI, Value of financial interest (in increments), Within 60 days of any Description of how FI relates subsequently identified to research, Key Elements of FCOI Management Plan. Annual FCOI Report Status of FCOI (i.e., whether Annual report due at the same FCOI is still being managed or time as when the Institution is no longer exists) and Changes required to submit annual to Management Plan, if progress report, multi-year applicable. progress report, or at time of extension. Revised FCOI Report If applicable, update a Following the completion of a previously submitted FCOI retrospective review when report to describe actions that there is noncompliance with will be taken to manage FCOI the regulation, if needed. going forward or make changes to originally submitted FCOI report. Mitigation Report Project Number, Project Title, When bias is found as a result Contact PI/PD, Name of of a retrospective review. Investigator with FCOI, Name of Entity with FCOI, Reason for review, Detail Methodology, Findings and Conclusion.
REQUIRED FCOI REPORTS TO BE PROVIDED TO NIH THROUGH eRA COMMONS FCOI MODULE REPORT CONTENT REQUIRED WHEN? New FCOI Report (Initial submission Grant Number, PI, Name of Entity with FCOI, Nature of FCOI, Value of financial interest (in increments), Description of how FI relates to research, Key Elements of Management Plan. Prior to expenditure of funds Within 60 days of any subsequently identified FCOI Annual FCOI Report Status of FCOI (i.e., whether FCOI is still being managed or no longer exists) and Changes to Management Plan, if applicable. Annual report due at the same time as when the Institution is required to submit annual progress report, multi-year progress report, or at time of extension. Revised FCOI Report If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward or make changes to originally submitted FCOI report. Following the completion of a retrospective review when there is noncompliance with the regulation, if needed. Mitigation Report Project Number, Project Title, Contact PI/PD, Name of Investigator with FCOI, Name of Entity with FCOI, Reason for review, Detail Methodology, Findings and Conclusion. When bias is found as a result of a retrospective review.