Registration on Clinicaltrials.gov

ClinicalTrials.gov is a worldwide registry and results database of publicly and privately supported clinical studies with human participants.

Defining Clinicaltrials.gov

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.

Public Disclosure of Clinical Trials Information

Why do we need to register on Clinicaltrials.gov?

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."

Who do we work with to register on Clinicaltrials.gov?

For questions regarding Clinicaltrials.gov registration, contact:

Lynn Jagodzinski

CTSI Clinical Research Regulatory Administrator

or

Urmo Jaanimägi

CTSI Quality Assurance Specialist

On this page:

Questions?

Lynn Jagodzinski
CTSI Clinical Research Regulatory Administrator 
(716) 888-4843
lynnjago@buffalo.edu

Or

Urmo Jaanimägi
CTSI Quality Assurance Specialist 
(716) 888-4760
uj@buffalo.edu

FDA definitions

Learn more about FDA definitions of applicable clinical trials.

How do we register on Clinicaltrials.gov?

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:

  • Your full name
  • Login name
  • Email address (email that you use frequently)
  • Phone (phone that you use frequently)

Learn more on how to submit studies.

How long does it take to register on Clinicaltrials.gov?

Completion time depends on the complexity of the study being registered. After study record Release, registration record reviews take approximately 2-5 business days to be returned. Applicable clinical trials and studies that are NIH-funded are prioritized by the PRS.  Other types of study records might take longer. If ClinicalTrials.gov PRS reviewers find problems with the record, it will be returned with PRS Comments.  The study record will not be accepted until all problems are resolved. 

What happens when my study is registered on ClinicalTrials.gov?

When ClinicalTrials.gov has accepted the study for registration the Responsible Party will receive the National Clinical Trial (NCT) number. The NCT is another term for the ClinicalTrials.gov registry number unique to each record. Records that have an NCT number are viewable to the public and cannot be deleted.