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Quality assurance in a large clinical trials consortium: The experience of the Tuberculosis Trials Consortium

  1. Author:
    Sandman, L.
    Mosher, A.
    Khan, A.
    Tapy, J.
    Condos, R.
    Ferrell, S.
    Vernon, A.
    Consortium, T. B. T.

  2. Author Address

    Duke Univ, Med Ctr, Durham, NC 27710 USA. NYU, Sch Med, Bellevue Hosp Ctr, New York, NY USA. Ctr Dis Control & Prevent, Atlanta, GA USA. Denver Hlth & Hosp, Dept Publ Hlth, Denver, CO USA. SAIC Frederick Inc, Frederick, MD USA.;Mosher, A, Duke Univ, Med Ctr, Box 3306, Durham, NC 27710 USA.;moshe001@mc.duke.edu
    1. Year: 2006
    2. Date: Dec
  2. Journal: Contemporary Clinical Trials
    1. 27
    2. 6
    3. Pages: 554-560
  4. Type of Article: Article
  5. ISSN: 1551-7144
  1. Abstract:

    Quality assurance (QA) is essential for data accuracy and proper evaluation of study objectives in clinical trials. The Tuberculosis Trials Consortium (TBTC)-a collaboration of 28 clinical sites and the Centers for Disease Control and Preventionhas developed a comprehensive QA program that provides quantitative assessments of performance based on clearly defined standards that are communicated to data collectors through a feedback process. The Implementation and Quality Committee of the TBTC developed a Site Evaluation Report (SER) that assesses performance measures (PMs) critical to the accomplishment of study objectives. PMs are defined, quantified, and evaluated, and goals and minimum acceptable scores are specified. Sites not meeting a PM minimum must provide an explanation and develop a plan to meet the goal. Site-specific and system-wide problems can be readily identified through this process.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.cct.2006.06.003
  3. View record in Web of Science®
  4. WOS: 000242790000008

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