Because data reviews are retrospective and largely observational in nature and, in general, exempt research studies are not controlled clinical trials, nor involving an FDA-regulated intervention, they would not need to be registered or reported on ClinicalTrials.gov.
However, the ICJME may have a different opinion if exempt research involves any of the following:
- 
Drugs; 
- 
surgical procedures; 
- 
devices; 
- 
behavioral treatments; 
- 
dietary interventions; 
- 
process-of-care change. 
- 
biomedical or health-related measures including pharmacokinetic measures and adverse events. 
