An Overview of Clinical Trials with the Integration and Introduction of an Electronic-Based Records System

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.