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How to Register a Clinical Trial

Step 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 him/her, should each obtain an individual account.  Based on your affiliation, contact the below unit to request an account:

Campus Units Cancer Center Medical School

Email the Office of Research Compliance Review (ORCR) 

Include your name, school/college, department, email address, and phone number

Complete the PRS Administrator Contact Request Form in ClinicalTrials.gov

Email the Regulatory Affairs Office 

Include your name, department, email address, and phone number

Step 2:  Register the Clinical Trial

  • Log into the PRS system and select "New Record" from the Quick Links menu.
    • The "Record Owner" of the registration record is the individual who begins the record.  At U-M, the Responsible Party should also be the Record Owner.  Once the Responsible Party has created the new record, they can give access to the record to any administrators who will help with registration.
  • Enter the required data elements.  Use the protocol, informed consent document(s), and the IRB application to complete the registration form. 
  • Ensure the HUM # is listed as the "Unique Protocol ID".
  • Preview, inspect, and submit the registration record. 
  • Verify in PRS that the Record Status is "Released."  ClinicalTrials.gov will not process the record unless it is released.  

For additional guidance, review ClinicalTrials.gov's Protocol Registration Data Element Definitions.  

Step 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.

FAQs

Required Informed Consent Language for Applicable Clinical Trials:

Applicable Clinical Trilas must use the unaltered consent template language provided below in the informed consent document:

  • "A description of this clinical trial will be available on http://www.clinicaltrials.gov/(link is external), as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Required Informed Consent Languaage for NIH and other Sponsor Requirements for Registration and Reporting

NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017).   Use the below language:

The above language is included in the U-M IRB informed consent templates.  Refere to the IRBMED Informed Consent Template and the IRB-HSBS Informed Consent Template.

You should plan for registration to take one to two hours.  Also note, that the PRS review process can take a few days, so plan accourdingly to ensure the study is registered on the public facing site within the required time-frame.

Once your study is registered and issued an NCT number, you need to add the NCT number to the study workspace in eResearch Regulatory Management.  To do so, follow the below instructions:

 

  1. If this is a multi-site trial, refer to the eResearch instructions regarding your responsibility for registering the study at ClinicalTrials.gov.
  2. Anyone who has edit rights on the study in eResearch can add the NCT number (no IRB staff involvement is required).
  3. Click the “Update NCT Number” on the left sidebar and enter the NCT number in the box provided.
  4. An 8-digit number is required – including 1 or more zeros at the beginning.

 

Questions?

For questions related to ClinicalTrials.gov, contact:

  • Medical School Units:  Office of Regulatory Affairs (734) 764-0634
  • Campus Units:  Office of Research Compliance Review (ORCR) at (734) 764-3628 or orcr-deptemail@umich.edu