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Definitions
Clinical Research
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A. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an
investigator (or colleague) directly interacts with human subjects. This area of research includes:
- Mechanisms of human disease
- Therapeutic interventions
- Clinical trials
- Development of new technologies
B. Epidemiologic and behavioral studies.
C. Outcomes research and health services research.
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Clinical Trial
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A clinical trial is a systematic, organized, prospective intervention study in human subjects that is conducted according to a formal study plan (protocol) and that has
measurable efficacy and/or safety-related outcomes that are amenable to statistical analysis. It employs one or more intervention technique(s) including prophylactic,
screening, diagnostic, or therapeutic agents, devices, or procedures. It must have approval of the IRB or review with a determination of exemption. Clinical trials are
distinguished from other types of clinical research (e.g., behavioral research) that may need IRB approval but do not meet the other criteria of clinical trials. |
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