Date of Award

12-1-2014

Degree Type

Internship Practicum Report

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Robert T. Mallet

Second Advisor

Peter B. Raven

Third Advisor

Craig Garrison

Abstract

It is imperative to minimize errors in essential data to achieve maximum reliability in a research study. The primary objectives of this practicum were to identify the advantages and disadvantages of using clinical trial management software in physical therapy research studies and to determine the ability of that software to improve data quality and therefore research validity. Using source data verification within three research studies at the site, 480 data points were verified retrospectively and 428 were verified prospectively. Following the use of the software, there was a significant reduction in multiple types of data errors at each subject research visit, with an overall error reduction of 86%. The largest limitation of the clinical trial management software is the time requirement for implementation and continuation in each enrolling research study at the site. Alternate electronic management systems should be evaluated for feasibility and improved data quality at the research site.

Comments

Pollard, Kalyssa M., Improvement of Data Quality through Source Data Verification in Physical Therapy Research. Master of Science (Clinical Research Management), November, 2014, 61 pp., 2 tables, 7 figures, bibliography, 9 titles. Available December 2015

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