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Screening and Evaluation of Study Subjects in Patient-Oriented Research
  1. Robert D. Toto, MD
  1. From the University of Texas Southwestern Medical Center Dallas, Dallas, TX.
  1. Received October 25, 2009.
  2. Accepted for publication November 6, 2009.
  3. Reprints: Robert D. Toto, MD, University of Texas Southwestern Medical Center Dallas, 5323 Harry Hines Blvd, POB II Room 7.711H, Dallas, TX 75930. E-mail: robert.toto{at}utsouthwestern.edu.

Abstract

This article describes practical aspects of screening and evaluation of potential study subjects for patient-oriented research. Screening and evaluation comprise the crucial initial steps in the process of any patient-oriented research study. Appropriate infrastructure, operations, and documentation of the procedures needed to efficiently and effectively conduct screening and evaluation are described. A stepwise approach for screening and evaluating potential study subjects for determination of study eligibility is described. The design and conduct of screening and evaluation procedures should be protocol driven and compliant with regulatory requirements.

Key Words
  • screening
  • evaluation
  • documentation
  • institutional review board
  • clinic space

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