Core Thematic Areas Competencies
IV. Research implementation

•      Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs.

•      Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding.

•      Incorporate regulatory precepts into the design of any clinical or translational study.

•      Integrate elements of translational research into given study designs that could provide the bases for future research, such as the collection of biological specimens nested studies and the development of community-based interventions.

V. Sources of error

•      Describe the concepts and implications of reliability and validity of study measurements.

•      Evaluate the reliability and validity of measures.

•      Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups.

•      Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts.

•      Implement quality-assurance systems with control procedures for data intake, management, and monitoring for different study designs.

•      Assess data sources and data quality to answer specific clinical or translational research questions.

•      Implement quality-assurance and quality-control procedures for different study designs and analysis.



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