USC Principal Investigators (PIs) are responsible for determining whether or not they are obligated to register and for any subsequent required updates including results reporting, in accordance with U.S. Public Law 110-85, Title VIII (or FDAAA) and/or other applicable requirements.
- Click here for details on Why Register?
- Click here for information on Who is Responsible for Registering the Trial on Clinicaltrials.gov?
Steps for Registering Your Non-Cancer Center Trial on ClinicalTrials.gov
- To request User account set up to the Clinicaltrials.gov Protocol Registration System (PRS) to register your trial, contact the appropriate
USC PRS Administrator below:
|For Non-Cancer Center Trials contact: Jean Chan, Associate Director HSC Dept. of Contracts and Grants Phone: (323) 442-2825 or Email: firstname.lastname@example.org||For Cancer Center Trials contact: TheClinical Investigations Support Office (CISO) of the USC Norris Comprehensive Cancer Center (for Cancer Center faculty with clinical trials) to receive separate instructions for registering cancer center trials: Kay Johnson, R.N., Associate Director Phone: (323) 865-0457 or Email: Johnson_K@med.usc.edu|
- Include Clinicaltrials.gov in the subject line if request is via email
- Provide your full name/USC phone #/USC email address, and
- Provide the U“C Lead PI’s full a e/U“C pho e #/U“C e ail address, if you are ot the PI.
- After receiving an auto-email from Clinicaltrials.gov with user login name and a temporary password, login to the Clinicaltrials.gov PRS at https://register.clinicaltrials.gov/ and complete the login fields:
- I the Organization” field, e ter U“C’s orga izatio a e asUSCalifornia(no spaces/case sensitive). Follow the instructions to change your temporary password to one you will remember.
- Go to Main Menu > Protocol Records > Create, then follow the prompts for creating your registration and filling in a series of data entry screens. Click on the various fields to access instructions for that field. Please note: Under the Responsible Party field:o The Responsible Party should always be the Principal Investigator.
- Important Reminder: As the PI or designee, you are responsible for entering your trial information, ensuring that it is correct, and updating the registry in a timely manner as required by law.
- Tip: Information may be copied and pasted into the data fields from an electric version of your protocol.
- Once all required sections/screens have been completed, the Edit Protocol screen will appear. Review the information provided and ensure all errors, comments, etc., have been addressed before clicking Complete , in the top, left corner of the screen.
- The Respo si le Party U“C PI , can then Approve & Release the re ord to Clinicaltrials.gov.
- Following a successful Clinicaltrials.gov system validation and internal QA review, the record will be Posted and made available to the public through the Clinicaltrials.gov website within 2-5 business days of release. New records may take up to 10 business days to be assigned an NCT number and appear in the databank.
|Keep your Protocol Record Updated: A verification or update of the data in active protocol records is required every six (6) months. Failure to login to the PRS and confirm or update your record(s) every six (6) months, regardless of whether there has been a change or not, may result in loss of funding and/or inability to publish the results of a study in an ICMJE associated journal. (Note: Upo logi to the PR“, e sure the Record Verification Date field is ha ged to refle t the urre t date. Important Tip: Clinicaltrials.gov will send a reminder email notification to you to update your study once every six (6) months.|
Questions? If you have questions about registering a trial at ClinicalTrials.gov, contact the appropriate USC PRS Administrator or Clinicaltrials.gov email@example.com.