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On April 27, 2017, the Office of Research Administration informed the Yale community of the following clinical trial registration and reporting requirements:
- National Institutes of Health’s (NIH) Policy on the “Disseminationof NIH-Funded Clinical Trial Information” (Notice Number: NOT-OD-16-149);
- Department of Health and Human Services (DHHS) complementary requirements regarding the Clinical Trial Registration and Results Information Submission Regulation requirements located at 42 CFR Part 11; and
- Human Research Protection Program’s (HRPP) Policy 1000, Clinical Trial Registration and Results Reporting Requirements
The HRPP is in the process of developing informational materials and will post these materials as they become finalized. In the meantime, the following FAQs will assist Principal Investigators in complying with the above policies and regulation. If at any time you have a question regarding your clinical trial, please contact the HRPP for assistance.
- Flowchart for Identifying an “Applicable Clinical Trial” Under the Final Rule
- NIH Clinical Trial Decision Tree
- Summary of HHS/NIH Initiatives to Enhance Availability of Clinical Trial Information
Frequently Asked Questions
If the research includes a behavioral intervention funded by the National Institutes of Health, then yes, your study would probably qualify as a clinical trial requiring registration. If you are uncertain as to whether or not your research award qualifies as a clinical trial requiring registration, the NIH Clinical Trial Decision Tree may be of assistance. If you are still unsure, please contact Yale.CTgov@yale.edu or HRPP@yale.edu for assistance.
It is highly recommended that a clinical trial is registered prior to enrollment of the first study subject. Failure to do so will restrict publication in journals that follow International Committee of Medical Journal Editors (ICMJE) requirements. Researchers should be aware of other registration requirements imposed by a sponsor and/or journals.
If you are absolutely certain that you will not be publishing in a journal that follows the ICMJE requirements, the clinical trial must be registered no later than 21 days after enrolling the first human subject participating in any of the following clinical trials:
- Interventional biological, drug, and device products regulated by the Food and Drug Administration (FDA) (except phase 1 trials of drug and biological products and small feasibility studies of device product); and
- Pediatric post-market surveillance study of a device product required by the FDA.
Again, it is highly recommended to register your trial prior to the enrollment of subjects, since your publishing expectations can change. For additional information regarding the ICMJE Clinical Trial Registration Requirements, please visit the following websites:
You have two options:
- Yale’s CTgov Team was created to work with principal investigators and their research teams at Yale to ensure that applicable clinical trials are in compliance with FDAAA Section 80, ICMJE, and/or NIH standards. The team provides assistance with account set up or password reset, registration of trials, and results reporting of completed trials. These services are currently free of charge. Please use this Intake Form to request the Team’s services or visit the Yale Center for Clinical Investigation, Registering a Study on ClinicalTrials.gov; OR
- Go directly to ClinicalTrials.gov’s Protocol Registration System (PRS). This system is a web-based tool developed for registering clinical trials and submitting clinical trials information. Records submitted through the PRS are available to the public at ClinicalTrials.gov.
Yes. Yale’s CTgov Team was created to work with principal investigators and their research teams at Yale to ensure that applicable clinical trials are in compliance with FDAAA Section 80, ICMJE, and/or NIH standards. The team provides assistance with account set up or password reset, registration of trials, and results reporting of completed trials. These services are currently free of charge. Please use this Intake Form to request the Team’s services or visit the Yale Center for Clinical Investigation, Registering a Study on ClinicalTrials.gov for more information.
What are the implications of not registering a qualified clinical trial?
- Failing to comply with federal requirements for trial registration and reporting in ClinicalTrials.gov may result in:
- Penalties to the Responsible Party of up to $11,000 per day (amount may be adjusted).
- The withholding of remaining or future NIH funding to the institution or investigator or recovery of monies already allocated.
- Public notice of failure in registry/results database.
- Injunction action or criminal prosecution brought by the Department of Justice (DOJ) for prohibited acts.
- The inability to bill Medicare.
- The Centers for Medicare and Medicaid Services (CMS) requires registration of Qualifying Trials before claims are submitted to Medicare. If a clinical trial does not qualify, then the costs for all items and services related to the clinical trial cannot be billed to Medicare.
For clinical trials subject to NIH Policy and the Final Rule, summary results for the primary outcome measure(s) must be entered no later than 12 months after the study’s Primary Completion Date (the last subject’s last visit). Results for secondary outcome measures must be entered 1 year after the date on which the final research participant is examined or receives intervention for the purposes of final collection for the secondary outcome measure. Other information may be required to updated more frequently. ICMJE and CMS do not have results reporting requirements.
You can work with Yale’s CTgov Team to ensure results are reported timely and in compliance with FDAAA Section 80, ICMJE, and/or NIH standards. These services are currently free of charge. Please use this Intake Form to request the Team’s services or visit the Yale Center for Clinical Investigation, Registering a Study on ClinicalTrials.gov for more information.