Research Roundtable: NIH Implements Changes to ClinicalTrials.gov Procedures

The changes to the procedures include:

1.  Centralized "Clinical Trials Compliance Workflow" developed to verify compliance.
   An automated system tracks registration and reporting, enabling NIH to act upon the earliest notification of a potential violation.
2. New forms introduced to enable better tracking.
   ClinicalTrials.gov identifiers, including National Clinical Trial number (NCTs) and other fields are mapped to the ClinicalTrials.gov record.
3. New ClinicalTrials.gov beta website released.
   The redesigned system supports more intuitive use and features that allow submitters to more easily identify trials that are subject to reporting requirements and alert users of approaching deadlines. The new ClinicalTrials.gov beta website includes an option to provide feedback about the site, access to public webinars, and a user-centered design approach.

The NIH policy NOT-OD-16-149 requires that all interventional clinical trials that are funded in part or whole by the NIH and submitted on or after January 18, 2017, must be registered and have results submitted in ClinicalTrials.gov. All interventional trials are included in this policy, even those that are not considered to be Applicable Clinical Trials (ACTs), such as behavioral, surgical, phase 1 drug, and feasibility device studies.

NIH trials are required to be registered in ClinicalTrials.gov no later than 21 calendar days after the enrollment of the first participant. Results information from those trials must be submitted no later than one year after the trial's Primary Completion Date.

The NIH policy refers to how researchers may recover some of the costs incurred due to compliance activities, such as registration on ClinicalTrials.gov. Grantees are permitted to:

• Charge the salaries of administrative and clerical staff as outlined in the relevant section of the NIH Grants Policy Statement.
• Recover administrative costs through indirect cost recovery.

The NIH Funding Institute’s or Center’s Office of Grants management sends 30-day notices of noncompliance to the responsible parties who have not submitted the results of their trial to ClinicalTrials.gov after the required reporting timeframe has passed. For responsible parties who fail to comply, the NIH may withhold further funding for the grant and possibly future grants. Additionally, the NIH may take timely reporting of clinical trials into consideration during review of subsequent applications for funding.

Additional validation checks for Research Performance Progress Reports (RPPR) will be assessed to ensure they meet the clinical trial registration and reporting requirements and that remaining funding is not released or subsequent awards are not issued until the noncompliance is resolved. The NIH intends to work closely with institution’s staff to ensure ClinicalTrials.gov compliance.

• "Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?" Use the decision tree here and see also the NIH definition of a clinical trial.
• ClinicalTrials.gov at the University at Buffalo (UB): At UB, individual investigators are responsible for entering and updating their study-related information in the ClinicalTrials.gov Protocol Registration and Results System (PRS) database. UB’s PRS account is SUNYBuffalo. For all UB investigators and their research teams, a UB-specific ClinicalTrials.gov Registration and Results Guide is available on the UB Clinical and Translational Science Institute (CTSI) website.
• Compliance with ClinicalTrials.gov registration and reporting requirements: At UB, compliance is monitored by Lynn Jagodzinski, CTSI Clinical Research Regulatory Administrator and Urmo (Mo) Jaanimägi, CTSI Quality Assurance Specialist. In addition to monitoring compliance, the UB ClinicalTrials.gov team offers continuous support to UB investigators who need assistance with account setup or have questions with registering their trial and/or entering the results into the ClinicalTrials.gov repository. Contact Lynn at lynnjago@buffalo.edu and Mo at uj@buffalo.edu.

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter. Add your email to the newsletter mailing list here.