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
Registering and Modifying Studies in ClinicalTrials.gov
User Name: (supplied by PRS at account setup)
Password: (supplied by PRS at account setup, or as changed by you)
- Clinical Trials Registration Brochure: http://prsinfo.clinicaltrials.gov/registering.pdf
- ClinicalTrials.gov Protocol Registration System Information: http://prsinfo.clinicaltrials.gov/
- PRS Quick Start Guide (accessible after login): https://register.clinicaltrials.gov/prs/app/template/QuickStartUser.vm?uid=U0000BLN&ts=1&cx=-m3glqv
- PRS User’s Guide (accessible after login): https://register.clinicaltrials.gov/app/prs/template/ReferenceGuide.vm/ts/8/uid/U0000BLN
- Required Protocol Data Element Definitions: http://prsinfo.clinicaltrials.gov/definitions.html
- Basic Results Data Element Definitions: https://register.clinicaltrials.gov/prs/html/results_definitions.html
- 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.
Other Functions Available with ClinicalTrials.gov