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Final Rule (42 CFR Part 11) Information

This page provides general information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The Final Rule clarifies and expands the 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 801). 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 with requirements 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 in relation to the Final Rule's 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 by the Final Rule. Receive notifications when new information is added by subscribing to the Hot Off the PRS! email bulletin.

This page was last reviewed in September 2019