Browsing by Subject "electronic documentation"
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Item An Overview of Clinical Trials with the Integration and Introduction of an Electronic-Based Records System(2014-12-01) Stewart, Adam T.; Gwirtz, Patricia A.; Gatch, Michael B.; Bell, April M.Currently the Office of Clinical Trials (OCT) at the University of North Texas Health Science Center relies on a paper-based records retention system. Conversion to an electronic-based records system will decrease data misplacement, improve study communication, and provide a firm foundation for file organization. In compliance with FDA regulations and OCT’s standard operating procedures, a shared drive was created for the retention of clinical records. Regulatory binders, patient records, study related source documents and protocols will be scanned and organized into folders and saved to in an organized system on the shared drive. The one-terabyte shared drive is backed up daily to maintain record accountability. In addition to the implementation of electronic record storage during my internship, I also saw subjects, entered data, organized records, and other site specific tasks.Item Analysis of Efficiency and User Satisfaction Following the Introduction of Digital Source Documents and Resources in a Clinical Research Setting(2015-12-01) Alosi, Marlena C.; Ladislav Dory; Patricia A. Gwirtz; Ray PageEfficient and accurate data management processes are essential for the successful conduction of clinical trials. The clinical research industry is unique among biomedical fields in that much of the reporting is still conducted using paper-based systems. Recent trends towards exchanging paper-based documentation methods for electronic documentation methods have shown that implementation of digital resources have the potential to expedite clinical development. This practicum sought to evaluate paper-based and electronic documentation processes in a cancer clinic in regards to efficiency and user satisfaction, and determine which documentation form was superior in these areas. Retrospective analyses and a survey were used as the sources of data to assess for these differences. It was determined that the replacement of paper-based methods with electronic methods of documentation at this particular clinic resulted in both greater timeliness and higher user satisfaction.