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Clinical Research Division - Registration of Clinical Trials

UofL Clinical Trials and ClinicalTrials.gov

 

What is ClinicalTrials.gov?

ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with all NIH institutes and the Food and Drug Administration (FDA). The ClinicalTrials.gov information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997 (Public Law 110-85). The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions.”

Basically, all federally and privately funded clinical trials must be registered at ClinicalTrials.gov along with:

  • Summary of the purpose of the study
  • Recruiting status
  • Criteria for patient participation
  • Location of the trial and specific contact information
  • Research study design
  • Phase of the trial
  • Disease or condition and drug or therapy under study

Who registers a study?

The law requires that the lead sponsor or designated principal investigator must register and report results of an applicable clinical trial. This generally includes interventional studies of drugs, biological products or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S., involves a drug, biologic or device that is manufactured in the U.S., or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

For purposes of UofL compliance, only investigator-initiated (whether government-awarded or industry-sponsored) or non-sponsored studies must be registered by their UofL investigators. Because the law mandates that registering is the responsibility of the lead sponsor, UofL’s clinical trial agreements reinforce that the sponsor is the party responsible for registering.

Who maintains the content?

The protocol “owner” maintains the content. For any given registered UofL study, the owner could be the PI, a person designated by the department, the Office of Clinical Research Services and Support (OCRSS), someone from the sponsor or CRO, etc. While some of those owners (such as OCRSS) have the ability to release their own records to the public, in most cases OIC must release records that are owned by University employees.

 

Getting Started with a New Account in ClinicalTrials.gov

  • Clinical trials are registered with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS). If you need to register a study with ClinicalTrials.gov but do not have an account in PRS, send a request to the UofL Office of Industry Contracts (OIC) via its service account.
  • The request should state that you would like to register a clinical trial on the ClinicalTrials.gov website and that you are requesting an individual account to be set up under the UofL institutional account. Be sure your message includes your full name, your office phone number and your email address.
  • OIC will create an account for you with your user login name (usually your first, or first and second initial and last name, no spaces), full user name, office phone number and email address.
  • You should receive an email from PRS with your new user ID and password within two to five days.
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    Registering and Modifying Studies in ClinicalTrials.gov

  • Access the Protocol Registration System (PRS) website at http://register.clinicaltrials.gov
      • Organization: ULouisville
        User Name: (supplied by PRS at account setup)
        Password: (supplied by PRS at account setup, or as changed by you)

  • Complete the forms for your protocol (and results, if applicable). For detailed information and instructions:
  • The Office of Industry Contracts (OIC) will automatically be notified by email when you mark your new study entry in PRS as “Completed,” as well as when you modify an existing record. However, please notify the Human Subjects Protection Program Office (HSPPO) via its service account when you complete or modify an entry.
    • NOTE: If the study is assigned a UofL tracking number (beginning with “IOIC,” “OICB” or “OICN,” for instance), please let OIC know so your ClinicalTrials.gov study can be attributed to the appropriate internal file.
  • OIC will review the registration and then release it to the ClinicalTrials.gov databank. Occasionally, the system will detect errors (e.g., missing information) that prevent the record’s release. In this case, OIC will alert the PRS account holder that it is unable to release the record until the errors are resolved. The protocol owner is responsible for correcting any errors.
  • OIC strives to release error-free records within two business days.
  • It may take up to 30 days while the record is being reviewed by PRS staff for a new trial to be seen in the databank.
  • Keep protocol records up to date. Protocol records for active trials should be reviewed and modified as needed at least every six months. Pay special attention to recruiting status and contact information, as the accuracy and timeliness of this information is extremely important to patients and health care professionals.
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    Other Functions Available with ClinicalTrials.gov

  • Occasionally the need may arise to change ownership of a protocol or to add access for an individual. OIC needs to have permission from the PI in order to make such changes. Send requests in the form of an email to OIC’s service account.
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