Clinical Trials Registration and Results Reporting (Clinicaltrials.gov)
Clinical Trials Registration
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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.
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
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
|Topic||FDAAA Law||ICMJE Policy||NIH Policy||CMS|
|Scope||Applicable clinical trials per FDAAA (ACT)||Interventional clinical trials (broad scope of "intervention")||NIH-funded clinical trials||Qualifying clinical trials|
|When to register||No later than 21 days of enrollment of the first subject||Prior to first subject enrollment||No later than 21 days of enrollment of the first subject||Before claims are submitted to Medicare|
|Results Reporting||No 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 trial||Excludes Phase 1 (drug) and Feasibility (device)||All||All||Qualified clinical trials|
|Intervention Type||All FDA regulated drugs, biologics and devices||All (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 publication||Loss of NIH funding: |
• For the PI
• For the
|Denial of claims|
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Where To Register
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.