Clinical Trials Registration and Results Reporting

Clinical Trials Registration

Resources

The ClinicalTrials.gov site contains all the information you need to register a study, edit a registration record, and report results from policies to specific procedures to data element definitions, templates, and checklists

ClinicalTrials.gov Support Materials

Public registration of clinical trial information is required:

When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (42 CFR Part 11).  This includes:
  • Controlled clinical trials of FDA-regulated drugs or biologics (Phases II – IV);
  • Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies); and
  • Research studies to test a clinical hypothesis about health outcomes, including those whose primary purpose is to affect clinical practice.

See the ClinicalTrials.gov “Applicable Clinical Trial (ACT)” checklist to determine if registration of a study is required per federal regulations.

When conducting a clinical trial funded by the National Institutes of Health (NIH) per NIH policy.  If the answer is “yes” to all four of the following questions, then the research study would be considered a clinical trial according to the NIH definition:
  • Does the study involve human participants?
  • Are the participants prospectively assigned to an intervention?
  • Is the study designed to evaluate the effect of the intervention on the participants?
  • Is the effect being evaluated a health-related biomedical or behavioral outcome?

See NIH Definition of Clinical Trial Case Studies for additional guidance in determining if a research study is an NIH defined clinical trial.

For publication in a journal that follows the International Committee of Medical Journal Editors’ (ICMJE) policy, which requires registration of clinical trials in a public trials registry as a condition of consideration for publication.

Summary of Requirements and Enforcement

 FDAAA LawICMJE Policy NIH Policy CMS
ScopeApplicable clinical trials per FDAAA (ACT)Interventional clinical trials (broad scope of "intervention")NIH-funded clinical trialsQualifying clinical trials
When to registerNo later than 21 days of enrollment of the first subjectPrior to first subject enrollment No later than 21 days of enrollment of the first subjectBefore claims are submitted to Medicare
Results ReportingNo later than 12 months after the Primary Completion Date (the last subject last visit)Not required No later than 12 months after the Primary Completion Date (the last subject last visit)Not required
Phase of the trialExcludes Phase 1 (drug) and Feasibility (device)AllAllQualified clinical trials
Intervention TypeAll FDA regulated drugs, biologics and devicesAll (including behavioral, diagnostics, dietary supplements, etc)All (including behavioral, diagnostics, dietary supplements, etc)Qualified clinical trials
If non-compliant• Public notice;
• FDA sanctions
• Civil monetary penalties (up to $10,000/day)
• Loss of HHS Funding to study and/or institution
Rejection of the publicationLoss of NIH funding:
• For the PI
• For the
Institution

Denial of claims

Resources

The ClinicalTrials.gov site contains all the information you need to register a study, edit a registration record, and report results from policies to specific procedures to data element definitions, templates, and checklists

ClinicalTrials.gov Support Materials

Where To Register

ClinicalTrials.govClinicalTrials.gov link

Other public databases exist for registering and reporting clinical trial results.  Some may charge investigators a fee for storage and maintenance of results data.  There is no charge for listing studies on ClinicalTrials.gov.

 

When To Register

Per federal regulations and NIH policy, new qualifying trials/studies must register no later than 21 days after the first participant is consented.  ICMJE recommends registration before beginning participant enrollment.

 

 

Who To Register

The individual responsible for registering a clinical trial/study is considered the “Responsible Party.”  At the University of Michigan, for investigator-initiated research, the Principal Investigator (PI) is expected to take on the role of the Responsible Party, with two exceptions:

  • If there is an IND or IDE held by someone other than the PI, the IND or IDE holder is the Responsible Party, and
  • Within the Oncology CTSU, the University of Michigan Cancer Center may retain Responsible Party status or may designate it to the Principal Investigator.

Multi-site studies should designate one PI and one institution as the Responsible Party.  Typically, the U-M PI is the Responsible Party if U-M is the lead performance site.

FAQ

References and Resources