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Records relating to all investigator disclosures of Financial Interests and the review of and responses to such disclosures (whether or not a disclosure resulted in a determination of Financial Conflict of Interest) and all actions under this policy or retrospective review shall be kept for at least three years from the date the final expenditures report is submitted to PHS or such other date as may be required by PHS, or for research funded by other sponsors, the date on which the final report is submitted to the sponsor or the research is completed or is terminated, whichever is later. For Covered Clinical Studies records must be kept for a minimum of two years following the approval or withdrawal of a marketing application or according to the terms of the clinical trial agreement, whichever is longer. |