Title

Converting from Paper-Based to Electronic Data Capture and Record Keeping in Clinical Trial Management: Benefits, Challenges and Practical Considerations

Date of Award

12-1-2015

Degree Type

Internship Practicum Report

Degree Name

Master of Science

Field of Study

Clinical Research Management

Department

Graduate School of Biomedical Sciences

First Advisor

Patricia A. Gwirtz

Second Advisor

April M. Bell

Third Advisor

Lisa Hodge

Abstract

Clinical research has lagged behind the technological advance of other healthcare fields. Most investigational sites depend on a paper‐based data capture and record retention system. This practicum project examined the various benefits and challenges of electronic data capture and electronic record keeping systems. Electronic systems can improve data integrity, reduce trial cost and increase efficiency in the course of a clinical trial. However, electronic systems can also pose some challenges, including implementation and training cost, decreased productivity, and issues with data security and health record privacy. This project discussed some practical considerations for investigational sites transitioning to electronic systems. These aims were accomplished by review of the literature and consulting investigational sites through an email questionnaire.

Comments

Castle, Colton. Converting from Paper--‐Based to Electronic Data Capture and Record Keeping in Clinical Trial Management: Benefits, Challenges and Practical Considerations. Master of Science (Clinical Research Management), November, 2014, 74 pp., 9 figures, bibliography. Available December 2016.

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