On July 22, 2022, the revised federal policies for ClinicalTrials.gov took effect, including new penalties for non-compliance. The financial penalty is significant ($13,237 per day of non-compliance), and existing and future NIH funding may be impacted. Specifically, the NIH has suggested that they may withhold grant awards for the entire institution in response to non-compliance. The ISMMS ClinicalTrials.gov Registration and Reporting policy requires departments to be responsible for any financial penalty incurred by their faculty member due to non-compliance.

The PI is responsible for registering the clinical trial and reporting results under the guidelines outlined in the ISMMS ClinicalTrials.gov Registration and Reporting policy.

Please note that more than 60 Pre-Notices of Non-Compliance have been sent to date. There are four notices of Non-Compliance posted on FDA.gov. If you receive a Pre-Notice letter of Non-Compliance or Letter of Non-Compliance, please contact the Office of Research Services (ORS) immediately by opening a ticket at ClinicalTrials.gov Assistance – Research 411 Portal – Jira Service Management (atlassian.net) and providing a phone number where you can be reached.

The ORS can provide support and help the PI navigate the ClinicalTrials.gov process. However, the PI is responsible for ensuring the proper registration and reporting for their clinical trial. For more information on ClinicalTrials,gov registration and reporting results, visit the Research Roadmap. If you have any questions or would like to request assistance, please contact the ORS via the Research 411 Portal.

 

 

 

ConduITS is supported by NCATS of the NIH’s CTSA Program. Any use of CTSA-supported resources requires citation of grant number UL1TR004419 awarded to ISMMS in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.