Issues and Improvements in the Management of Multicenter Research as Discovered Through the Practice of Clinical Research Coordinator (CRC)

Abstract

Tohoku University Hospital served as the research office for two projects of Kampo medicine treatment: an observational study and a randomized controlled study on Coronavirus Disease 2019 led by the Japanese Society for Oriental Medicine. We review the practical operations together with the results of a questionnaire survey conducted after the completion of the studies, and discuss issues and areas for improvement in the management of the multicenter research office. Questionnaire 1 surveyed the participants’ impressions and opinions of the implementation system and responses at the research-sharing facilities, as well as future issues. Comments on observational studies were dichotomized into “no particular problems” and “difficulties.” In the randomized controlled trial, most respondents answered, “It was difficult to understand the administrative procedures for specific clinical research.” Questionnaire 2 surveyed the status of clinical research support staff, their impressions and opinions of being entrusted with the work, and future issues. We were able to collect opinions about impressions, issues, and areas for improvement from a variety of perspectives. Looking back at the summary of the questionnaire survey and the practical experience, smooth promotion of research is expected through appropriate research planning and system construction, as well as improvement of research support skills.