ClinicalTrials.gov Support
Get help determining if your study is required to be listed on ClinicalTrials.gov and assistance with registration and updates.
How we can help
- Determine if your study should be registered.
- Provide registration assistance.
- Notify you of requests for updates.
- Assist you with entering study results.
ClinicalTrials.gov requirements
Other types of studies may choose to register, but aren’t required to do so. Note that some journals require registration prior to publication.
Noncompliance penalties
Records that fall out of compliance are subject to civil monetary penalties, either as a one-time fee or, if violations are not resolved in 30 days, a daily fee for each day the violation remains uncorrected. Current penalty amounts are listed in 45 CFR 102.3 (look for the row for 21 USC 333(f)(3)(A)); as of 2023, fees can be as much as $14,262.00 per day.
Federal funders of non-compliant records can decide to withhold remaining funding for that non-compliant trial, and they can even decide not to fund future studies if registration and results submissions are not verified.
ClinicalTrials.gov Deadlines and Extensions
Throughout the lifecycle of your project, there will be various time points where an update to your ClinicalTrials.gov listing is required. This section is intended to help you understand those time points.
The link to register and make edits/updates to records is https://register.clinicaltrials.gov/. Our organization name is University_Of_Minnesota. Please note that the Masonic Cancer Center has a separate organization name; they can be contacted at [email protected].
Questions? Need help? Email us at [email protected]
When to register
You can register as soon as you have a finalized protocol -- this is easiest to remember. Otherwise, the formal requirements for registration timing are as follows:
| Per regulations: | If you plan to publish in a ICMJE1 journal: | If your trial is funded by PCORI2: | If your trial is funded by the VA ORD3: |
|---|---|---|---|
| No more than 21 days after your first participant is enrolled | At or before the time of first patient enrollment | At or before the time of first patient enrollment | Before funding from the ORD will be released |
- International Committee of Medical Journal Editors
- Patient-Centered Outcomes Research Institute
- US Department of Veteran’s Affairs Office of Research and Development
After registration, the individuals who manage ClinicalTrials.gov will review your information for accuracy and provide feedback.
Responses
Be sure to watch your email and the study page in the registration system for PRS reviewer queries or flagged errors to your registration.
Any queries or errors must be responded to within 15 calendar days.
Updates
At minimum, all records must be updated at least once every 12 months.
The following events should also trigger an update in your ClinicalTrials.gov listing:
| Study Start Date | IRB Status | Recruitment Status | Primary Completion Date | Study Completion Date |
|---|---|---|---|---|
| Within 30 calendar days of your first participant enrolled | Within 30 calendar days of a change | Within 30 calendar days of a change | Within 30 calendar days of completed data collection for the primary outcome | Within 30 calendar days of completed data collection for other outcomes and adverse events |
Document uploads
At key times throughout the trial, there are a number of documents that are required to be added to the official record. These include:
- A protocol with statistical plan must be uploaded for applicable clinical trials at the time of results entry (see below).
- A consent form must be uploaded for any study supported by a federal agency as soon as the trial closes to recruitment, and no later than 60 days after the last study visit by any participant.
Results
When you are required to post results on ClinicalTrials.gov is dependent on your funding source, as well as the type of trial you are conducting.
| Applicable Clinical Trial | Funded by NIH1 or VA ORD | Funded by PCORI |
|---|---|---|
| No later than one year after the entered primary completion date | No later than one year after the entered primary completion date | At least 30 days before the draft final report is due to PCORI |
Results responses
Be sure to watch your email and the study page in the registration system for PRS reviewer queries or flagged errors.
Any queries or errors must be responded to within 25 calendar days.
Escalation plan
University of Minnesota ClinicalTrials.gov administrators will reach out to individuals listed in the posted record when responses or updates are needed. Administrators will reach out weekly if no response is received. After four attempts without a resolution, the lack of resolution will be escalated in the following order:
Department Head
↓
HRPP Quality Assurance
Jessy Thomas, MS, DMFT
↓
Medical School Director of Compliance
Sarah Averbeck, JD
↓
Associate Dean for Research Operations
Peter Crawford, MD, PhD
↓
Dean of Medical School, Vice President for Clinical Affairs
Jakub Tolar, MD, PhD
Cost
Free for University of Minnesota investigators.
Consult with an expert
Sydney Viel
Regulatory Affairs Program Manager
[email protected]
Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)