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Published on: January 16, 2019
Screening and evaluation of study subjects in patient-oriented research
1University of Texas Southwestern Medical Center Dallas, Dallas, TX 75930, USA. robert.toto@utsouthwestern.edu
Summary
This article outlines practical screening and evaluation methods for patient-oriented research participants. It details essential infrastructure, operations, and documentation for efficient subject selection and regulatory compliance.
Area of Science:
- Clinical Research
- Patient-Oriented Studies
- Research Methodology
Background:
- Screening and evaluation are critical initial phases in patient-oriented research.
- Efficient and effective subject selection underpins study validity.
- Regulatory compliance is paramount throughout the research process.
Purpose of the Study:
- To describe practical aspects of screening and evaluating potential subjects for patient-oriented research.
- To detail necessary infrastructure, operations, and documentation for these processes.
- To present a stepwise approach for determining study eligibility.
Main Methods:
- Describing infrastructure, operations, and documentation for screening and evaluation.
- Outlining a stepwise protocol-driven approach for subject assessment.
- Emphasizing adherence to regulatory requirements.
Main Results:
- Provides a framework for efficient and effective screening and evaluation.
- Ensures protocol-driven and regulatory-compliant procedures.
- Facilitates accurate determination of study eligibility.
Conclusions:
- Effective screening and evaluation are foundational to successful patient-oriented research.
- Implementing robust infrastructure, operations, and documentation is key.
- Protocol adherence and regulatory compliance ensure research integrity.
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