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Trial Registration

Do I need to register my study?

Agencies have different registration requirements:

Agency Studies
Food and Drug Administration Applicable ClinicalTrials.*
National Institutes of Health (NIH) All NIH funded studies evaluating a health-related biomedical or behavioral intervention**
Center for Medicare and Medicaid Services Trials Billing for Services.
International Committee of Medical Journal Editors All Trials

We recommend that you register all trials, including trials with behavioral interventions.

*ClinicalTrials.gov provides a checklist to help you determine if your study is an ACT: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

**You will find the definition here: https://grants.nih.gov/policy/clinical-trials/reporting/steps.htm and https://researchintegrity.syr.edu/nih-clinical-trials

What happens if I don’t register my study?

Agencies differ in penalties for failure to register a study. All penalties are significant:

Agency Studies
Food and Drug Administration Civil monetary penalties of $11,000+/day
National Institutes of Health (NIH) NIH funds withheld from the PI and the Institution
Center for Medicare and Medicaid Services Denial of claims
International Committee of Medical Journal Editors Rejection of the publication

Yale is committed to full compliance with registration requirements. If you are noncompliant, the Yale Center for Clinical Investigation (YCCI) will contact your department chair. University officials may administratively suspend your study, hold new IRB submissions or take additional actions.

For details, see Yale’s policy (p.8): https://your.yale.edu/sites/default/files/hrpp-policy-1000-clinicaltrialregistrationandresultsreporting18apr2017.pdf

Who is responsible for my study record (i.e., “responsible party”)?
The “sponsor” who initiated the trial (e.g., Yale University) is the responsible party unless the study involves an FDA-regulated drug, biologic, or device; then, the principal investigator (PI) is the responsible party.
Who will register my study?

Study teams should register their studies in the Protocol Registration and Results Reporting System (PRS) at https://register.clinicaltrials.gov/

Contact the Yale ClinicalTrials.gov team if you need assistance.

How do I register my study?
  • ClinicalTrials.gov provides step-by-step guided tutorials to assist you with study registration: https://prsinfo.clinicaltrials.gov/tutorial/content4/index.html#/
  • Contact the ClinicalTrials.gov team at Yale to obtain login information and for assistance with registration.
  • Click on the “Help” and “Definitions” tabs in your study record for additional detailed guidance detailed guidance
  • Our team is available to assist you and will review your study prior to submission to ClinicalTrials.gov.
Do I need to register the study at Yale if another entity (e.g., manufacturer) wrote the protocol?
  • No, the sponsor who initiated the study should register it.
  • The study should only be registered by one institution.
  • Coordinate with the sponsor and collaborators to ensure timely study registration.
When does my study need to be registered?
  • Before HIC approval.
  • Before the first subject is enrolled.
  • Make sure that you leave enough time to complete the registration and the review of your registration by ClinicalTrials.gov so that your study will be public before you enroll the first subject.
    See information below for when you should begin the process and how much time you should allot.
How much time will it take to register my study?
A registration may take 2 to 8 hours to complete per Office of Management and Budget estimates: https://prsinfo.clinicaltrials.gov/omb-burden-statement.html
What do I do when I have completed the registration?
Once you have completed the registration, it must be released for ClinicalTrials.gov review.
  • If the study involves an FDA-regulated drug, biologic, or device, the principal investigator (PI) is the responsible party and must release the study.
  • The ClinicalTrials.gov team at Yale must release all other studies. Please let us know when the registration is complete.
How long will it take for ClinicalTrials.gov to review my registration?
Five business days.
How will I know when ClinicalTrials.gov has completed its review of my study registration?
ClinicalTrials.gov will send an e-mail to the record owner (the PI of record) and to our ClincalTrials.gov Team at Yale.
What feedback can I expect from ClinicalTrials.gov?
  • In some cases, ClinicalTrials.gov will approve your results following its review.
  • In other cases, ClinicalTrials.gov will provide comments and expect you to edit your registration before approval. You will be able to view the comments when you open your study record.
Can I get help addressing comments?
Yes, contact the Yale ClinicalTrials.gov team if you need assistance.
When will my registration be made public?
  • Your record will appear on the ClinicalTrials.gov public website once ClinicalTrials.gov approves it.
  • You can find the public website here: https://clinicaltrials.gov/
When do I get my NCT number?
ClinicalTrials.gov assigns National Clinical Trial (NCT) numbers after you submit your registration and ClincalTrials.gov reviews the record and makes it public.