ClinicalTrials.gov: Does Your Study Need to be Registered?

Registration on ClinicalTrials.gov is a requirement for all National Institutes of Health (NIH)-funded clinical trials and all Food and Drug Administration (FDA) “Applicable Clinical Trials." This CTSI Educational Modules video explores:

  • Why some research studies require registration on ClinicalTrials.gov
  • The types of research the NIH consider to fall under “clinical trials”
  • The different agencies that require the registration of clinical trials on the site
  • The consequences of not registering a study on the site

Presenter: Alexis O'Brien, CTSI Clinical Research Facilitator

Developed by Lynn Jagodzinski, CTSI Clinical Research Regulatory Administrator

Running Time: 13 minutes

Posting Date: Oct. 19, 2021

Questions?
 Contact Lynn Jagodzinski, CTSI Clinical Research Regulatory Administrator, at lynnjago@buffalo.edu, or Urmo Jaanimägi, CTSI Quality Assurance Specialist, at uj@buffalo.edu.

Additional resources:
 Is it an ACT? https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
NIH clinical trial decision tool: https://grants.nih.gov/ct-decision/index.htm
ClinicalTrials.gov Registration and Results Guide