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Glossary

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Observational Study

research in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

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Observational Study Model

1) Cohort: group of individuals, initially defined and composed, with common characteristics, who are examined or traced over a given time period 2)Case-control: group of individuals with specific characteristics compared to group(s) with different characteristics, but otherwise similar 3) Case-only: single group of individuals with specific characteristics 4) Case-crossover: characteristics of case immediately prior to disease onset (or hazard period) compared to characteristics of same case at a prior time (i.e., control period) 5) Ecologic or community studies: geographically defined populations, such as countries or regions within a country, compared on a variety of environmental and/or global measures not reducible to individual level characteristics 6) Family-based: studies conducted among family members, such as genetic studies within families or twin studies and studies of family environment

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Observational Study Time Perspective

the temporal relationship of observation period to time of subject enrollment. Prospective: look forward using periodic observations collected predominantly following subject enrollment Retrospective: look back using observations collected predominantly prior to subject selection and enrollment Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollment

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Off Site Research

designates research conducted at study sites that are not part of the Íø±¬³Ô¹Ï.

Office of Human Research Protections

office responsible for implementing HHS regulations governing HHS funded research with human subjects. (OHRP)

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Office of Laboratory Animal Welfare

office responsible for implementing HHS regulations governing use of animals in PHS funded projects. (OLAW)

OIACP

abbreviation for the Íø±¬³Ô¹Ï Office of the Institutional Animal Care Program.

OIRB

abbreviation for the Íø±¬³Ô¹Ï Office of the IRB.

Onsite Monitoring

monitoring or auditing a study while on the Íø±¬³Ô¹Ï campus.

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ORCA

abbreviation for the VPR's Online Research Compliance Assistant application.

ORU

Organized Research Unit provides support for interdisciplinary research that complements the academic goals of departments of instruction and research. These units are typically referenced as institutes, laboratories, or centers (e.g., Mays Cancer Center or Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases)

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