ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. In accordance with the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), applicable trials must be registered and have results reported on clinicaltrials.gov. In addition, trial registration is required for journal publication of any clinical trial results.
Applicable trials must be registered on clinicaltrials.gov before participant enrollment begins. Please see our FAQs below for more information on applicable trials.
Register Your Study
Follow our step-by-step study registration guide to register and maintain your study.
Please email Sarah Ford-Trowell at email@example.com to request a clinicaltrials.gov account.
If you are unsure if you need to register your study, please refer to our FAQs below or email us at firstname.lastname@example.org.
Report Your Results
Ready to report results to ClinicalTrials.gov?
Step one is to gather the data that you've collected for the following:
- Participant Flow: How many people started versus finished each period of your study and how many dropped out along the way.
Most studies only have one period. However, some studies (for example, crossover studies) may have more. For example: Period 1: “First Treatment for 2 Weeks”, Period 2: “Washout, 3 Week”: Period 3: “Second Treatment for 2 Weeks”.
- Baseline Characteristics: Demographics data, such as age/sex/ethnicity/race of your participants, and any study-specific baseline measures that you collected, if any.
- Outcome Measure Data: These are very basic tables of the data that you collected for each of your Outcome Measures. The table rows will be the measurement and the columns will be the arms/groups of participants.
- Adverse Events: All SAEs, and any AEs that occurred at a frequency over a certain threshold (if any).
Next, follow the PRS Guided Tutorials for Entering Results, which will take you through the process step-by-step.
Identifying and Resolving Records with Problems
Problems will be listed in your Record List. When viewing your Record List on your home page, review the Problems column to identify any Problems on your records. Please follow our guide to update your records.
For more information on the problems records may have, please see the PRS User's Guide.
ClinicalTrials.gov Information Sessions
The Office of Clinical Research hosts quarterly information sessions, open to responsible parties and anyone who participates in ClinicalTrials.gov record ownership. Please submit any questions during registration or email them to email@example.com.
|Thursday, December 7, 2023
2:00 - 3:00pm
|Register for December 7th|
|Thursday, March 7, 2024
2:00 - 3:00pm
|Register for March 7th|
Thursday, March 9, 2023
Thursday, June 8, 2023
Frequently Asked Questions
- Are there penalties if I don’t register my study and report the results?
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.
- When should I register my study in ClinicalTrials.gov?
GWU requires studies to be submitted 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.
- When do I need to report results?
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.
- What are my responsibilities as Record Owner?
The record owner can be the PI or a study coordinator who has been delegated 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).
Please notify Sarah Ford-Trowell (firstname.lastname@example.org) who you would like to be your designated Record Owner, or if the current Record Owner is leaving the institution and who you want to replace them so an account can be set-up or transferred.
- Keeping the record up to date
- What are my responsibilities as the Responsible Party?
The P.I. or the study Sponsor is responsible for:
- Registering the study on ClinicalTrials.gov
- Maintaining, updating, and releasing the record
- Reporting basic results data to ClinicalTrials.gov, if required
Please note that incoming or departing faculty must transfer their ClinicalTrials.gov records with them.
- Do I need to register my study?
The regulations governing posting 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 GWU MFA faculty, the faculty P.I. is responsible for registering the study and maintaining the posting.
For industry-sponsored trials, the sponsor will register and maintain the record.
- How do I get an account in ClinicalTrials.gov?
Please email Sarah Ford-Trowell at email@example.com if you need an account set up for you.
- What if I am leaving the institution?