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Final Rule Information

This page provides general information about the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The rule clarifies and expands requirements for submitting clinical trial registration and results information to in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The final rule is intended to make it clear to sponsors, investigators, and the public which trials must be reported, when they must be reported, and whether compliance has been achieved. The effective date for the final rule is January 18, 2017 and the compliance date is April 18, 2017. Section IV.F. of the final rule (81 FR 65118-22) describes how the new requirements apply to the submission of clinical trial registration and results information, taking into consideration the Study Start Date and Primary Completion Date relative to the effective date. This page will be updated to provide more details on data submission requirements, including the formatting of certain types of clinical trial information required in the final rule. To receive notifications when new information is added, join the NIH FDAAA Update listserv.