ClinicalTrials.gov is a worldwide registry and results database of publicly and privately supported clinical studies with human participants.
The National Library of Medicine (NLM) at the National Institutes of Health (NIH) maintains the website. It relies on the sponsors and principal investigators of clinical studies to provide and update information on the site. Usually the sponsor and/or PI will register on clinicaltrials.gov when they begin and update the information throughout the study. Investigators also may be required to report study results. There is no fee to register a study.
Currently, you must register on clinicaltrials.gov if your study meets the FDAAA 801 definition of an "applicable clinical trial." While not always required, we generally recommend that all drug or device trials be registered.
Additionally, you must register if you plan to publish in journals. The International Committee of Medical Journal Editors (ICMJE) requires all trials be registered before they would publish research results generated by a clinical trial.
Learn more about the FDA definition of an "applicable clinical trial."
For questions regarding Clinicaltrials.gov registration, contact: Lynn Jagodzinski
The site uses a web-based data entry system called the Protocol Registration and Results System (PRS) to register clinical studies and to submit results information for registered studies. You must have a PRS account to register study information on ClinicalTrials.gov.
Before applying for a PRS account, you should ensure that you are the appropriate individual to submit clinical study information to ClinicalTrials.gov. To avoid duplicate registration, studies should be registered only by the responsible party. To help you determine who is responsible for registering a study and submitting results, see the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).
ClinicalTrials.gov establishes one PRS account per organization (such as a company, university or medical center). All investigators from that organization who are conducting studies would be designated as users of this single PRS account. UB’s PRS account is SUNYBuffalo.
You can contact the UB PRS Administrator, Lynn Jagodzinski, to request a user login. Please provide the following information for account set up:
Learn more on how to submit studies.
Completion time depends on the complexity of the study being registered.
Note: The National Clinical Trial (NCT) number is another term for the ClinicalTrials.gov registry number unique to each record. The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.,: NCT00000419.