ClinicalTrials.gov is an online database of federally and privately supported research studies conducted in the US and around the world. DOCR is the system administrator for ClinicalTrials.gov for Duke.
If you have questions, contact the DOCR ClinicalTrials.gov team.
How to request a ClinicalTrials.gov account
Email the DOCR-ctgov@duke.edu to request a new account. Within 2 business days you will receive an email from DOCR containing your login name and another email from ClinicalTrials.gov with your temporary password.
As soon as possible log on to the Protocol Registration and Results System to reset your password. From the user account menu in the top right corner, select "Change Password".
ClinicalTrials.gov Log on information
https://register.clinicaltrials.gov/
Organization: DukeUMC
Username: Firstname Lastname (e.g. Taylor Swift)
Password: When your account is created, ClinicalTrials.gov will email a temporary password
Contact DOCR-ctgov@duke.edu if you need your password reset
Training is not required to get access to ClinicalTrials.gov. However, users responsible for managing ClinicalTrials.gov records are encouraged to take the applicable trainings below
| Course Name and Description | Link |
|---|---|
|
Intro to ClinicalTrials.gov: Regulation and Policy Overview: This module will provide an introduction to ClinicalTrials.gov and cover why it is important to register and report results, who is responsible, when to register, and the Duke process. |
Register |
| ClinicalTrials.gov: Registering Trials and Maintaining Records: This module will walk you through who can register trials in ClinicalTrials.gov, what information is included in a registration, resources to help with registration, and what is required for record maintenance once a trial is registered. | Register |
| ClinicalTrials.gov: Results Submission Overview: This module will cover which studies must submit results, what information is required for results submission, when to submit results, and Duke's process for results submission. | Register |
ClinicalTrials.gov Microlearning Videos
This WarpWire library houses several short videos to help clinical research staff with specific functions in ClinicalTrials.gov. Any ClinicalTrials.gov videos created for training purposes will be added to this library.
ClinicalTrials.gov was mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and expanded under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Final regulations 42 CFR Part 11 became effective January 18, 2017. Over the years other federal and non-federal agencies have also developed disclosure policies and recommendations.
All Investigators are encouraged to register and report results on ClinicalTrials.gov to promote research transparency. The table below summarizes disclosure requirements as outlined in the regulations and policies noted.
Which studies are required to register on ClinicalTrials.gov?
Duke investigators are only responsible for registering Duke-initiated protocols
|
|
Trials of FDA-regulated products |
NIH-funded Clinical Trials |
Revised Common Rule Clinical Trials |
Qualifying trials billing insurance |
Research publishing in a medical journal |
|---|---|---|---|---|---|
| Which studies must be registered? |
"Applicable Clinical Trials" (ACTs):
More info: ACT checklist |
Clinical trials funded in whole or in part by NIH:
More info: NIH policy |
Any "clinical trial" conducted or supported by a Common Rule department or agency Public posting of one consent form after enrollment has closed (no later than 60 days after last study visit) More info: Revised Common Rule FAQs |
Clinical trials that meet the qualifying criteria outlined by CMS and are billing insurance
More info: DOCR-startup@duke.edu |
Any human research project that is:
More info: ICMJE policy |
| What information is required? | Registration and Results | Registration and Results | Registration and consent upload | Registration | Registration |
|
When do I have to register? Per Duke Policy |
Prior to institutional approval | Prior to institutional approval | Prior to institutional approval | Prior to institutional approval (Maestro Care signoff) | Prior to enrolling the 1st participant, per ICMJE policy |
| Related policies and regulations | FDA Amendments Act of 2007 (FDAAA) and final rule 42 CFR Part 11 | NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information | Revised Common Rule | CMS: Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims |
DOCR reviews all protocols submitted to the DUHS IRB for ClinicalTrials.gov requirements. If you have questions about which requirements may apply to your study, please email DOCR-ctgov@dm.duke.edu.
ClinicalTrials.gov Language in the Consent Form
By federal regulation, ACTs must include the following language in the consent form. The language cannot be altered in any way.
- "A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time."
NIH policy also requires a registration disclosure statement in the consent form. We recommend using the same language but without the mention of US law.
- "A description of this clinical trial will be available on www.ClinicalTrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time."
Consequences of noncompliance
- Public notices of noncompliance and violations.
- Civil monetary penalties up to $13,237 per day for Applicable Clinical Trials (ACTs).
- Suspension or termination of NIH funding.
- Consideration of the noncompliance in future NIH funding decisions for the institution.
- Publication may be denied by journals that follow the ICMJE policy. A list of journals that follow ICMJE policy can be found here. Individual journals may also have their own policies.
- Claims submitted to Medicare may be returned if the NCT# is not included on the claim.
- Records are identified as non-compliant on the ClinicalTrials.gov public site.
Duke’s escalation policy can be found in the Clinical Trials Disclosure policy.
The ClinicalTrials.gov Protocol Registration and Results System (PRS) site is undergoing a modernization effort, and the modernized site will be the default site when users log in on Wednesday, August 28th.
Users will be able to enter protocol information on the modernized site, but other functionality (e.g., results entry and document upload) is limited or not yet available. The classic PRS site will continue to be an option and is recommended for use as ClinicalTrials.gov continues to implement bug fixes and expand functionality of the modernized site.
Resources
- Modernized ClinicalTrials.gov PRS Tip Sheets
- How to Create or Edit a Study Record (Modernized PRS)
- How to Approve and Release a Study Record (Modernized PRS)
- About the ClinicalTrials.gov Modernization
What is not changing?
- There is no change to the ClinicalTrials.gov regulations or related policies. The same information is required to be submitted within the same time frames according to the regulations, NIH policy, and Duke’s Clinical Trials Disclosure policy.
- Results submissions and document uploads will continue to be submitted on the classic site until this functionality is available within the modernized site.
- Your log-in information will remain the same.
- https://register.clinicaltrials.gov/
- Organization: DukeUMC
- Username: Firstname Lastname
- Password: DOCR can reset if needed
Overview
The study team is responsible for entering study information into ClinicalTrials.gov. After the record is marked Entry Complete, DOCR reviews the submission for compliance with both regulatory standards and ClinicalTrials.gov review criteria. Once the record is Released, ClinicalTrials.gov PRS staff thoroughly review the record (usually takes 2-5 days). For new registrations, they will either assign an NCT# and post the study record to the public website, or return the study record with comments that must be addressed within 15 calendar days.
Record Owners are responsible for keeping study information current. DOCR will help monitor compliance for studies that meet the definition of an Applicable Clinical Trial, NIH-funded clinical trial, and/or clinical trials subject to the revised Common Rule and will notify Record Owners if records require action.
Resources
Applicable Clinical Trials and NIH-funded clinical trials are required to submit results on ClinicalTrials.gov within one year of the primary completion date (i.e. final data collection for the primary outcome measure). Extensions are only allowed under very limited circumstances.
Results must be submitted on time, even if:
- Enrollment goal is not met
- Study is terminated
- Results are not statistically significant
- Publication/presentation is pending
- Some data are missing (what is collected must be reported)
Overview
Once the study’s primary completion date has been reached and updated in the study record, DOCR will send an email notification to the study team (PI, ClinicalTrials.gov Record Owner, and RPM) so they are aware of the due date and results submission process.
Submissions must be complete one month prior to the regulatory due date to allow time for internal review and avoid last-minute submissions. The study team can either enter the data directly into ClinicalTrials.gov or provide the data in a manuscript or completed template and we will enter it into ClinicalTrials.gov on your behalf. Email DOCR-ctgov@duke.edu to request a study-specific results template to help gather the required data.
Once a results submission is released to ClinicalTrials.gov, they can take up to 30 days to complete their review (this may take even longer for studies that are not ACTs or NIH funded trials). Once their review is complete, the Record Owner will receive an email either letting them know their results have been posted or that the submission has been returned with comments that must be addressed within 25 calendar days. Results submissions may be publicly posted even if comments have been issued.
What information is required?
The below information must be entered into the data tables within the ClinicalTrials.gov Results module. All data that were collected must be reported.
- Participant Flow (the number of participants who started and completed the study)
- Baseline Characteristics (age, sex/gender, race, ethnicity, and study-specific measures used in the primary outcome measure)
- Results for the primary outcome measure(s) and any other secondary measures that are complete, as well as statistical analyses
- Adverse Events (SAEs, AEs, and all-cause mortality)
- Protocol and statistical analysis plan (Must be posted publicly with the results). The study team should confirm posting of the protocol/SAP is consistent with all contracts, if applicable.
Resources
- Email DOCR-ctgov@duke.edu to request a study-specific excel template to help gather the data
- How to Submit Your Results (ClinicalTrials.gov)
- PRS Guided Tutorials (ClinicalTrials.gov) – Scroll to the Results Tutorials