The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. Who Is Responsible for Registering Trials and Submitting Results? Other FDAAA 801 Requirements: NIH and FDA.Are There Potential Legal Consequences If I Fail to Register or Submit Results?.When Do I Need to Submit Results Information?.Which Trials Must Have Results Information Submitted to ?.Who Is Responsible for Registering Trials and Submitting Results?.See the documents provided in the Data Element Definitions, Templates, and Checklists section in Support Materials. Receive notifications when new information is added by subscribing to the Hot Off the PRS! email bulletin.įor details about submitting information to, see The Final Rule has been in effect since January 18, 2017.įor complete Final Rule requirements, please refer to 42 CFR Part 11.įor additional information on the Final Rule, also see the Final Rule Information page andįrequently Asked Questions.
Modo 801 requirements registration#
The Final Rule clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain trials to, in accordance with FDAAA 801. This page also provides summary information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The regulation became effective on January 18, 2017, and responsible parties have been required to be in compliance starting April 18, 2017. The statutory requirements have been in effect since September 27, 2007, have been codified at section 402(j) of the Public Health Service (PHS) Act, and include conforming amendments to the Federal Food, Drug, and Cosmetic FD&C Act (FD&C Act).
![modo 801 requirements modo 801 requirements](https://1.bp.blogspot.com/-B-RcpWT9P5w/Wh87o4jbzyI/AAAAAAAAABA/l1cMB_skQ-8a1u2PaCVOmfzdCai2-ihEwCLcBGAs/s1600/dgkeghdjegdhjg47d4gd4dg4ydg4.jpg)
Section 801 of the Food and Drug Administration Amendments Act of 2007 (PDF), known as FDAAA 801.
![modo 801 requirements modo 801 requirements](https://www.digitalengineering247.com/images/article/hot_rod_01_opt_620.jpeg)
This page summarizes the clinical trial registration and results information submission requirements described in