Browsing by Subject "data collection"
Now showing 1 - 3 of 3
- Results Per Page
- Sort Options
Item Clinical Internship with the Anterior Segment Clinical Division at Alcon Laboratories, Inc.: Electronic Data Capture (EDC) Approach vs. Paper-Based Approach to Data Management(2003-11-01) Crout, Danyel C.; Rouel Roque; Judy Vittitoe; Terri PasquineAlthough electronic data capture (EDC) has been available for 20 years or more, companies have remained hesitant about its applicability to enhance clinical trial conduct. Before any company adopts a process that is new to their organization, the procedures and regulations must be practiced and perfected. Pilot trials are developed to gain more knowledge and ease about the proposed process change. Already this year, the clinical data management (CDM) department reported that they have processed over a quarter-million paper case report forms (pCRFs). CDM is an internal component in maintaining clinical trial databases to be used during FDA submissions for approval to market a test article, therefore, data management processes are constantly improved while options are cyclically evaluated. EDC has been recently recognized within Alcon as a possible alternative to improving the efficiency of data collection while simultaneously decreasing data processing time. As a result, this prospective option was compared against the two processes of data management that Alcon currently uses with paper CRFs.Item Factors that Impact Patient Enrollment in Clinical Trials(2014-12-01) Duong, Phong; Shi, Xiangrong; Gwirtz, Patricia A.; Lovely, Rehana S.Introduction: Medical progress, now more than ever, demands clinicians to provide tangible proof over sound hypotheses. This is where clinical research steps in as a combatant to the unknown provoked by logical theories and sound hypotheses. The one constant in clinical research is that recruitment strategies are always changing. Analyzing factors that impact recruitment will effectively serve to improve the quality of clinical research conduction. Objective: The purpose of this project is to determine if there are certain factors in an individual’s life that has influenced them to participate in a clinical research study. Methods: To address the specific aims of the practicum project, a fifteen-question survey was administered to subjects enrolled in four different studies at Plaza Medical Center of Fort Worth. Data analysis was conducted using the Chi-Square Significance Test. Results: The data yielded Chi-Square values of 11.355 (Personal Influence), 14.129 (Family Influence), 186.242 (Research Staff influence), 40.581 (Financial Influence), and 56.871(Physician Influence). The values were tested under the following parameters: α=0.05 with four degrees of freedom. Conclusions: This leads to a rejection of the null hypothesis and implies that there are factors in a subject’s life that influences their decision to participate in a research study.Item Improvement of Data Quality through Source Data Verification in Physical Therapy Research(2014-12-01) Pollard, Kalyssa M.; Robert T. Mallet; Peter B. Raven; Craig GarrisonIt 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.