ClinicalTrials.gov at UVA

• Jodi Darring is the ClinicalTrials.gov PRS Administrator for UVA. Email her at jgd7s@uvahealth.org if you need an account set up.

• The regulations governing registration require that Applicable Clinical Trials be registered, and have basic results reported to ClinicalTrials.gov. See Which Trials Must be Registered.
• Some funding agencies, NIH, Bill and Melinda Gates, also require posting as do many journals.
• For investigator-initiated studies conducted by UVA faculty, the faculty Principal Investigator is responsible for registering the study and maintaining the record. The study team can help in this process but the PI still has to review and approve the record during the process.  The study team member and the PI will both need an account on ClinicalTrials.gov.  Typically, for industry-sponsored trials, the sponsor will register and maintain the record.

• UVA requests studies to be registered with ClinicalTrials.gov before enrollment begins. Applicable Clinical Trials and NIH-Funded Clinical Trials are required to register within 21 days of enrolling the first subject.  However, ICMJE policy requires registration prior to the start of enrollment.  For this reason, UVA requests that you register your study prior to enrolling the first subject.

• You may register your study on ClinicalTrials.gov prior to getting approval if the Overall Recruitment Status of the study is Not Yet Recruiting (see Overall Recruitment Status data element on ClinicalTrials.gov).
• If a study requires human subjects review board approval, approval must be obtained before the study’s Overall Recruitment Status is changed to Recruiting. When board approval is obtained, please update the Protocol Section of the study record in the Protocol Registration and Results System (PRS) and Release (submit) the study for processing.

• Yes, Section 801 of FDAAA amended the FD&C Act authorizes civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements.
• In relation to federally funded studies, section 402(j)(5)(A) of the PHS Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information. ICMJE policy requires, and recommends that all medical journal editors require, registration of clinical trials prior to the start of enrollment as a condition of consideration for publication.
• Additionally, ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding posting of results to ClinicalTrials.gov.

• The record owner can be the PI or a study coordinator who has been delegated to this role. As Record Owner you are responsible for:
• Keeping the record up to date
  • Update the record at least every 12 months until the study status is changed to “Completed”, “Terminated”, or “Withdrawn” (update at least every 6 months while actively recruiting).
• Addressing problems, errors, and major issue comments in the record in a timely manner.
• Reporting study results, if required, within 12 months of the study Primary Completion Date (usually the last study visit date).

• The Principal Investigator or the Sponsor are always listed as the responsible party on a record. The responsible party is responsible for:
  • Registering the study on ClincialTrials.gov
  • Maintaining, updating and releasing the record for review the ClinicalTrials.gov
  • Reporting basic results data to ClinicalTrials.gov, if required
• Please note that incoming or departing faculty must transfer their ClinicalTrials.gov records with them. If you need help with this process, contact Jodi Darring (jgd7s@uvahealth.org)
• The Responsible Party may designate someone on their team to complete the duties listed above. However, the Responsible Party will always have to review, approve and release the record when updates are made.

• Results must be posted within 12 months of the Primary Completion Date, that is, within 12 months of the last study visit where you collected data for your primary outcome measure. This 12 month deadline has nothing to do with IRB closure, publication, data analysis, etc. so be prepared to enter your data within 12 months of your last study visit.
• Good Cause Extension
  • A Good Cause Extension (GCE) request form that allows PIs to request an extension on reporting results. This form must be filled out BEFORE the one-year mark of the primary completion date. This request will not be accepted if it is past the one-year primary completion date. This form can take up to 45 days for the PRS Administrators to review. If the PI disagrees with the ruling, they will have 30 days to appeal the ruling.
  • When the investigator opens up their study to the Record Summary Page, they can scroll down to the Results Section where there will be a “Delay Results” button to select. Once selected, it will take the investigator to the form they can fill out explaining why the results may be delayed.
• Late Results Reporting Letter
  • If a PI or study receives a late results reporting letter from the NIH, the PI has 30 days to post the results. Failure to do so within those 30 days will lead to enforcement action by the NIH which for an ACT includes notifying the FDA and FAPIIS (Federal Awardee Performance and Integrity Information System) as well as withholding funds from the entire institution, not just the PI.

• The School of Medicine Clinical Trials office offers assistance for your ClinicalTrials.gov registration and results reporting. While we cannot enter the information on your behalf, we provide guidance and support to help you navigate the process and address any challenges you may encounter. Please feel free to reach out to us anytime for assistance.

For ClinicalTrials.gov-related queries at UVA, you can contact Jodi Darring, our dedicated resource, at jgd7s@uvahealth.org. She is available to assist you with any questions or concerns you may have.