A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
A drug used for conditions other than those approved by the FDA.
A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.
Describes a clinical trial in which masking is not used. This means that all parties involved with the trial know which participants have been assigned which interventions.
An FDA category of medication used to treat rare diseases and conditions.
