Glossaries
Glossaries
| Term | Definition |
|---|---|
| observer assessment |
An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. an interviewer simply capturing subject self assessments is not making an observer assessment. Compare to PRO, proxy assessment.
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| observational study |
A non-interventional study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York; www.strobe-statement.org] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial.
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| observation |
An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome.
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| objective |
The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective.
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