Summary of Clinical Trial Registration Requirements

EntityClinical Trial DefinitionRegistration & Reporting RequirementsPenalties
ICMJEAny 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
NIHA 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
FDAApplicable 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
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