How to Register in ClinicalTrials.gov

1. Request an individual account to ClinicalTrials.gov

Request an individual account to the ClinicalTrials.gov Protocol Registration and Results Submission System (PRS). A PI, as well as any administrator who will assist the PI, should each obtain an individual account. To request an account use the Electronic Research Administration (ERA) Help Ticket system.

  • Login into the ERA Help Ticket system using your UT EID and password.
  • Select “Request System Access/Info” on the left menu.
  • Complete all sections of the request form.
  • In the section “Additional Information/Comment(s)/Question(s),” include your phone number in the box.
  • Once all sections are complete click the “submit” button at the bottom of the page.

OR

Based on your affiliation, contact the following to request an account.

Campus UnitsDell Medical School
Office of Research Support & Compliance Quality Program
orsc@uts.cc.utexas.edu

Email your name, school/college, department, email address, and phone number along with your request.
Research Operations Team
dellmedctgov@austin.utexas.edu

Email your name, school/college, department, email address, and phone number along with your request.

After your request is processed, you will receive a log-in name and temporary password from ClinicalTrials.gov by email.

2. Register the clinical trial

The “Record Owner” of the registration is the individual who begins the record. At UT, the Responsible Party should also be the Record Owner. Typically, the Responsible Party will be the PI. Once the Responsible Party (PI) has created the new record, s/he can give access to the record to any administrators who will help with registration.

  • Log into the PRS System and select “New Record” from the Quick Links menu.
  • Select “UTexasAustin” as the organization.
  • Click “New Record” and enter the required data elements. Use the protocol, informed consent documents, and the IRB application to complete the registration form.
  • Use the UT IRB # as the “Unique Protocol ID.”
  • Preview, inspect, and once all sections are complete, click “complete.”
  • The PI, as Responsible Party, will then “Approve” and “Release” the record to ClinicalTrials.gov for review.
  • Verify in PRS that the “Record Status” is “Released.” ClinicalTrials.gov will not process the record unless it is released.

More information is available at How to Register.

3. Address PRS Review Comments

Anytime the Responsible Party releases a record, PRS staff will review it for any apparent errors, deficiencies, and/or inconsistencies based on the PRS Review Criteria. If PRS Staff identify potential issues with your record, they will add comments to your record. Major comments must be corrected or addressed. Comments identified as Advisory, should be addressed to improve clarity of the record.

Once a record is released, the Responsible Party should:

  • Monitor the record for any PRS review comments.
  • Respond, in a timely fashion, to any communications from oversight units (i.e. Regulatory Affairs, ORCR, etc.) regarding PRS review comments related to your study record.
  • Make corrections in response to PRS review comments within 15 days.
  • Release the record for PRS review, once all corrections have been made.

Once the record is accepted by ClinicalTrials.gov staff for publication, the record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.

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