Observational studies are essential when randomization is unethical or impractical. They may still be human-subjects research if the investigator obtains identifiable data or interacts with participants.
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Glossary Term
Observational Study
Study Design
Also known as: non-interventional study, observational research
A study in which investigators observe outcomes without assigning interventions, including cohort, case-control, and cross-sectional designs.
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