If after reading the requirements information, you determine that you need to register your clinical trial at ClinicalTrials.gov, call your trial’s sponsor/program officer. Ask whether the trial has already been registered and/or whether the sponsor intends to register the trial.
If the answer is “no” to both questions, proceed to step 1, below.
If the sponsor states that the trial has already been registered, check the information about your trial on ClinicalTrials.gov, e.g., for multi-site studies, be sure that your site is listed and that the information is accurate.
If the sponsor intends to register the trial, be sure that registration occurs before you enroll your first subject. Once the trial has been registered, check the record for accuracy.
To register your trial:
- Send an email message to: email@example.com. The message should be sent by the person who will be creating the Protocol Record for a clinical trial, i.e., the PI or the PI’s designee. A Protocol Record can have only one “User” (also known as “Owner”).
- Include in the message your name, telephone number, and email address and state you would like to be registered as a User.
- Receive by return email a login name and a temporary password.
- Go to the Clinicaltrials.gov Registration web site.
- Complete the login fields. If you are a UConn Health investigator, in the “Organization” field, state “UConnHealth.” If you are a UConn Storrs or Regional Campus investigator, in the “Organization field, state “UConn.”
- Browse the Main Menu page. Under “User Account,” follow the instructions for changing your temporary password as soon as possible. Save your password; you will need it for periodic updates and verification. Under “Help”, refer to the “User’s Guide” for additional information. As the PI, or PI designee, you are a User and are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner (for updating, see NOTE at the end of this section).
- On the Main Menu page, under “Protocol Record” click on “Create” and complete the study description template. Note that required fields are marked with
- * [a red asterisk] = required by ClinicalTrials.gov
- FDAAA [in green] = required to comply with US Public Law 110-85, Section 801
- (FDAAA) [in green] = may be required to comply with US Public Law 110-85, Section 801
Work your way through the data fields to complete the Protocol Record. Data are saved as each screen is filled in, so that you can “Quit” at any time, saving the Record for later completion using “Modify”.
Complete the following (potentially confusing) fields as follows:
- Organization’s Unique Protocol ID: Use the IRB number.
- Secondary ID: now required; use grant number, or some other number unique to the trial; if necessary, make up your own
Investigators from UConn Health:
- Board Name: Use UConn Health IRB
- Board Affiliation: Use UConn Health
- Board Contact E-Mail and phone: Use your study’s IRB panel Coordinator
- Pam Colwell – firstname.lastname@example.org, 860-679-1019 (Panel 1 and CICATS and new expedited/exempt submissions)
- Donna Horne – email@example.com, 860-679-4851 (Panel 2 and new expedited/exempt submissions)
- Patricia Gneiting – firstname.lastname@example.org, 860-679-4849 (Panel 3 and new expedited/exempt submissions, facilitated reviews)
- Board Contact Address: UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511
Investigators from University of Connecticut Storrs and Regional Campuses:
- Board Name: use University of Connecticut IRB
- Board Affiliation: use University of Connecticut
- Board Contact E-Mail: email@example.com
- Board Contact Phone: (860) 486-0986
- Board Contact Address: Office of Research Compliance, 438 Whitney Rd., Ext., Unit 1246, Storrs, CT 06269
Investigators from UConn Health and University of Connecticut Storrs and Regional Campuses:
- Oversight Authorities: If this is not an FDA-regulated protocol, state “United States: IRB”
- Collaborators: Other organizations (if any) providing support, including funding, design, implementation, data analysis and reporting.
- Record Verification Date: Enter the month and year in which you complete and submit the Protocol Record to the PRS Administrator.
- Primary Completion Date: final data collection date, specifically regarding the Primary Outcome Measure
- Last Follow-Up Date: When creating the Protocol Record, specify the anticipated last follow-up date.
- Specifying Study Arms: along with Data Definitions, help is available at https://prsinfo.clinicaltrials.gov/definitions.html#Arms
- Conditions: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
- Keywords: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
- Investigators: list all investigators on the approved IRB protocol and Appendix A.
Automatic messages from the electronic system:
- WARNING: indicates a data element required by the FDA Amendments Act of 2007 has not been entered.
- ERROR: indicates a serious problem that needs to be addressed
- ALERT: indicates a problem that needs to be addressed; generally that problem is a missing data element required by ICMJE
- NOTE: indicates a potential problem that should be reviewed and corrected, as needed
- Protocol Records must be free of the first three messages in order to be approved and released to ClinicalTrials.gov for processing and publication
ClinicalTrials.gov data element definitions are available to the User on the registration site, or at http://prsinfo.clinicaltrials.gov/definitions.html
- If the PI did not personally complete the Protocol Record, send the draft template to her/him for review and approval. Note: This is an important step. The PI will be required to sign-off on a paper copy of the completed template prior to release to ClinicalTrials.gov for publication on the site.
- Submit the completed, PI-approved, Protocol Record by clicking on “Complete”. The completed template will go electronically to the UConn PRS Administrator. It is at this point that the Administrator will send a paper copy to the PI for sign-off, as described above in #8. The PRS Administrator will verify IRB Approval. After receipt of PI sign-off and confirmation of IRB approval, the Administrator will approve and release the template to ClinicalTrials.gov.
IMPORTANT NOTE: The PI, or PI designee, is responsible for updating the Protocol Record within 30 days of any changes made to the study, e.g., changes in recruitment status, protocol revisions, contact information, etc. The PI, or designee, is also responsible for verifying the Protocol Record at least once every six months while the study is active ( even if there have been no changes) and annually after the study has been completed. As a courtesy, for active studies at UConn, the UConn PRS Administrator will notify the User at 5 months that the Protocol Record is due to be updated in the next 30 days. For completed studies, the Administrator will notify the User at 11 months that the Protocol Record is due to be updated in the next 30 days.
Does the registration posting need review by the IRB?
No, the UConn IRB does not review the postings.