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ClinicalTrials.gov Registration

If after reading the requirements information, you determine that your clinical trial needs to be registered at ClinicalTrials.gov, call your trial’s sponsor/program officer to 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:

    1. Send an email message to the local ClinicalTrials.gov Administrator, Ellen Ciesielski, eciesielski@uchc.edu.  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 “Owner.”
    2. Include in the message your name, telephone number, and email address and state you would like to be registered as a User.
    3. Receive by return email a login name and a temporary password.
    4. Go to the Clinicaltrials.gov Registration web site.
    5. Complete the login fields. If you are a UConn Health investigator, in the “Organization” field, type “UConnHealth.”  If you are a UConn Storrs or Regional Campus investigator, in the “Organization field, type “UConn.”
    6. 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).
    7. 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 – engelson@uchc.edu, 860-679-1019 (Panel 1 and CICATS and new expedited/exempt submissions)
        • Patricia Gneiting – gneiting@uchc.edu, 860-679-4849 (Panel 2 & 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: doug.bradway@uconn.edu
      • 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 are completing the record.
      • Primary Completion Date: final data collection date, specifically regarding the Primary Outcome Measure
      • Responsible Party: The Principal Investigator should be listed as the Responsible Party.
      • 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.

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

To maintain your record and remain in compliance with the Final Rule, you must update the data fields on the schedule detailed in the table:

Data Field Deadline for Updating
(i.e., not later than the specified date)
Study Start Date 30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
Intervention Name(s) 30 calendar days after a nonproprietary name is established.
Availability of Expanded Access 30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record. [1]
Expanded Access Status 30 calendar days after a change in the availability of expanded access.
Expanded Access Type 30 calendar days after a change in the type(s) of available expanded access.
Overall Recruitment Status 30 calendar days after a change in overall recruitment status. [2]
Individual Site Status 30 calendar days after a change in status of any individual site.
Human Subjects Protection Review Board Status 30 calendar days after a change in status.
Primary Completion Date 30 calendar days after the clinical trial reaches its actual primary completion date.
Enrollment At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
Study Completion Date 30 calendar days after the clinical trial reaches its actual study completion date.
Responsible Party, by Official Title 30 calendar days after a change in the responsible party or the official title of the responsible party.
Responsible Party Contact Information 30 calendar days after a change in the responsible party or the contact information for the responsible party.
Device Product Not Approved or Cleared by U.S. FDA 15 calendar days after a change in approval or clearance status has occurred.
Device Product Not Approved or Cleared by U.S. FDA 15 calendar days after a change in approval or clearance status has occurred.
Record Verification Date Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.
[1] If expanded access to an investigational drug product becomes available after a clinical trial of that drug product has been registered and an expanded access record has not yet been created, a responsible party who is both the manufacturer of the investigational product and the sponsor of the applicable clinical trial must also, not later than 30 calendar days after expanded access becomes available, submit the data elements in accordance with 42 CFR 11.28(c) to create an expanded access record.

[2] If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.