Browsing by Author "Bell, April M."
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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 Converting from Paper-Based to Electronic Data Capture and Record Keeping in Clinical Trial Management: Benefits, Challenges and Practical Considerations(2015-12-01) Castle, Colton; Gwirtz, Patricia A.; Bell, April M.; Hodge, Lisa M.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.