AN INVESTIGATION OF CLINICAL TRIAL MANAGEMENT FROM AN RESEARCH ADMINISTRATORS PERSPECTIVE;
Best, Katherine F
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Clinical trial research is performed across the world and is an important component of research administration. The complexity of clinical trials highlight the importance of the initial stages of clinical trial set up within an institution. Without a proper process, lengthy negotiations get drawn out even further, and poor document management leads to extensive delays in getting appropriate information to the institution, sponsor, and research group. While policies and procedures are available within Johns Hopkins, the way in which clinical trials are managed within the Department of Medicine is reliant on individuals working on trials in their respective divisions. This means, analysts and researchers must rely on word of mouth, and co-workers as to who they contact to get their clinical trial up and running. This researcher surveyed anonymous individuals within the research administration field to assess if the clinical support issues run into by the researcher was a common issue amongst others in the field of clinical trial management. While the number of participants was much less than expected, the results echoed the researchers hypothesis, in that the need for internal clinical trial management guides is dire. In question 5 of the survey, participants were asked “Does your institution provide clear policy and management structure guidelines regarding clinical trial management?”; 90% of participants answered no (Best, 2020). The results from the survey, literature review, and personal experience of the researcher, were then utilized to develop the Department of Medicine Initial Clinical Trial Management Guide within Appendix A. While there are many steps within the clinical trial management process, the researcher focused on the first step in getting a clinical trial initiated within an institution. The guide provides users with definitions, essential departmental contact information, checklists, forms, and email templates, to guide them through the initial steps of a clinical trial initiated within the Johns Hopkins University Department of Medicine. Although much support is still needed to assist analysts in managing clinical trials, this guide fills a hole within the Johns Hopkins University Department of Medicine in the initial stages of clinical trial management.