Summary of Clinical Trial Registration Requirements
Entity | Clinical Trial Definition | Registration & Reporting Requirements | Penalties | |
---|---|---|---|---|
ICMJE | Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. | Registration: Prior to first enrollment | Results Reporting: None Data Sharing: Publication must include data sharing statement | Inability to publish in ICMJE journals |
NIH | A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. | Registration: Within 21 days of first enrollment (keep in mind that ICMJE requires prior to 1st enrollment) | Results Reporting: No later than 12 months after primary completion date | Loss of grant funding Future funding may be affected |
FDA | Applicable Clinical Trial Drugs & Biologics: controlled clinical investigations, other than Phase 1 of products subject to FDA regulation Devices: 1) controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies 2) pediatric postmarket surveillance as required by FDA | Registration: Within 21 days of first enrollment (keep in mind that ICMJE requires prior to 1st enrollment) | Results Reporting: No later than 12 months after primary completion date | Civil monetary penalties up to $11,383 per day until noncompliance is resolved |