Browsing by Subject "Clinical Trial Management"
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Item Clinical Trial Management Analysis and Integration of New Policies and Procedures Into a Research Department(2013-05-01) Schroedter, Lori L.; Ladislav DoryThe purpose of this practicum was to increase productivity and efficiency in the clinical research department. Using the guidelines set out by the FDA and ICH, the team set out to maintain compliance. The addition of an organizational system will assist the staff in the endeavor of clinical research. Over the course of this internship experience, the research department added new processes, forms, and databases, increased productivity and patient interaction, and decreased the amount of time doing tasks. The main goal of the practicum project was to implement a set of tools to increase organization in the research department. As these tools were developed, they were implemented. After the collection and analysis of the data, it was determined that overall there was a slight increase in the productivity and efficiency with the research personnel. With all of the information working together, it decreased the number of tasks, and the time it took to complete some tasks.Item Evaluation of New Operating Procedures for Submitted Investigator-Initiated Research to Baylor's IRB(2013-05-01) Rutter, Taylor M; Claire KirchhoffRutter, Taylor M., Evaluation of New Operating Procedures For Submitting Investigator-Initiated Research to Baylor’s IRB. Master of Science (Clinical Research Management), May, 2013, 97pp., 6 tables, bibliography, 24 titles. Purpose: To create a toolkit for investigator-initiated research outlining the resources available and the necessary steps to submit an application to the BUMC IRB and to make this a more efficient and satisfactory process. Hypothesis: A toolkit for investigator-initiated research that outlines the steps to complete Baylor’s Internal Review Board (IRB) submission process will decrease the timeframe that is needed for IRB approval and decrease the confusion with the application process. Design: A pilot toolkit was designed to aid in the IRB submission process for investigator-initiated research studies. A survey was distributed to toolkit users to gather information about their satisfaction with it and the effect that it had on efficiency. Results: The pilot toolkit was an anticipated item for researchers at Baylor. The packet was helpful and they were satisfied with the product. The preliminary results show that the packet reduced the time needed to obtain IRB approval.