What is ClinicalTrials.gov?

ClinicalTrials.gov is a public registry of clinical trials maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The clinicaltrials.gov website is designed to provide patients, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials on a wide range of diseases and conditions. The Protocol Registration and Results System (PRS) is a web-based tool developed for submitting clinical trials information to ClinicalTrials.gov.

Why is it important to register clinical trials and report results?

• Commitment to research participants
• Scientific Integrity
• Ethical standards
• Responsible stewardship of federal funds
• Required by Law (FDAAA)
• Required by NIH (for NIH-funded research)
• Required for Journal Publication (ICMJE)

What are the regulations and policies on clinical trial registration and results reporting?

DHHS and the NIH have released a new regulation and policy that affect registration and results reporting for clinical trials. The DHHS regulation, known as the Final Rule, describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov.

A complementary NIH policy applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule. Both the NIH policy and the Final Rule took effect January 18, 2017.

Who is responsible for registering trials and submitting results?

The "Sponsor" of the study is considered the responsible party for registering the trial in a public registry. The Sponsor of industry-initiated and funded multi-center studies is the pharmaceutical company whose protocol you are following and they are responsible for registration in ClinicalTrials.gov. In most cases, the sponsor of the trial will be the "responsible party" for registering the trial. However, in some cases, the regulations allow the sponsor to delegate all registration and reporting responsibilities to the principal investigator (PI).

For investigator-initiated studies led by UNC faculty, UNC is considered the Sponsor and the University is therefore responsible for ensuring that those studies are registered. UNC is a registered Sponsor at ClinicalTrials.gov, and the Office of Clinical Trials has designated a PRS Administrator for the University's account. At UNC, responsibility for registration and results reporting is delegated to the Principal Investigator as the "responsible party." The PI requests an account from UNC's PRS Administrator in order to begin the registration process in ClinicalTrials.gov.

What trials should be registered on ClinicalTrials.gov?

Required by Law — FDAAA 801:
Trials that meet the definition of "applicable clinical trial" (ACT) must register on the site. Applicable Clinical Trials include the following:

• Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation
• Trials of devices : 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post-market surveillance required by FDA

Review the ACT checklist (pdf) to determine if your trial meets the definition of an ACT, which requires registration and reporting of results.

Investigators holding an IND or IDE typically submit Form 3674 (pdf) to the FDA certifying that the study will be registered in clinicaltrials.gov. This form accompanies the initial IND or IDE submission as well as the addition of a new protocol to an existing IND or IDE.

Required by NIH Policy for NIH-funded clinical trials

All NIH-funded clinical trials* must register and report results. The policy applies to all NIH-funded awardees and investigators conducting clinical trials funded in whole or in part by NIH regardless of study phase, type of intervention, or whether the trial is an "applicable clinical trial" subject to FDAAA (including phase I). This requirement extends to clinical trials funded by NC TraCS' Pilot award and KL2 Scholar programs, both of which receive support from NIH's CTSA grant.

*NIH Definition of Clinical Trial:

• Per the NIH, a clinical trial is "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
• NIH has developed case studies to help you determine if your study would be considered by NIH to be a clinical trial: grants.nih.gov/policy/clinical-trials/case-studies.htm

Required for journal publication — International Committee of Medical Journal Editors (ICMJE)

Journals registered with ICMJE require:

• Registration of clinical trials in a public registry (ClinicalTrials.gov) at or before enrollment of the first participant.
• Registration is a condition for publication of research results.
• ICMJE encourages posting clinical trials results in ClinicalTrials.gov, but it is not required.

Researchers are strongly urged to contact their journal or publication source to verify whether or not registration on ClinicalTrials.gov is required in order to publish results.

Are there fines if I don't register my trial?

Yes. FDAAA and NIH have posted penalties for failure to comply with regulations and policies. Serious fines ($10,000 + daily) can be issued to UNC if investigators are not compliant with the requirements. Lack of compliance could result in the PI being unable to obtain future funding from the NIH.

Watch a short cartoon about the importance of clinical trial registration and data submission created by our colleagues at UAB:

How do I register my trial on ClinicalTrials.gov?

• The Protocol Registration and Results System (PRS) is located at register.clinicaltrials.gov.
• New users must request an account from UNC's PRS Administrator by sending an email to:
  • This email address is being protected from spambots. You need JavaScript enabled to view it. for Lineberger Comprehensive Cancer Center (LCCC) and oncology clinical trials
  • This email address is being protected from spambots. You need JavaScript enabled to view it. for all other clinical trials (non-LCCC or oncology trials)
• To learn more about registering an investigator-initiated clinical trial in a public registry, visit the UNC OCT website.

More Information

• To understand the new HHS and NIH policy affecting clinical trials, see research.unc.edu/clinical-trials/clinical-trials-gov
• Additional resources to help you better understand the Final Rule and NIH Policy changes:
  • A summary of the Final Rule and NIH policy
  • A table comparing and contrasting the Final Rule and NIH policy
  • A summary table of changes to clinical trial registration and results information data elements resulting from the Final Rule (pdf)
• NIH Definition of Clinical Trial and Case Studies: grants.nih.gov/policy/clinical-trials/case-studies.htm