Implementation of Clinical Research Coordinator Hospital Certification Course to Spread Understanding of Clinical Trials

Background and objectives: In Japan, the contribution of clinical research coordinators to trials for drug approval is now well recognized in investigators. In 2013, we initiated a clinical research coordinator hospital certification course at our facility. The purpose of the course is to pre-educate medical staff who are candidates for future roles of clinical research coordinator, and to spread recognition of clinical research. Methods: To obtain information from course participants, we conducted a qualitative study in 2014, using a focus group interview in six participants who had completed the course in 2013. The initial topic was perceptions of the course before and after participation. Other topics were the present status and issues in clinical research coordinators. Results: All participants agreed that the course was acceptable and effective in reexamining their own work and roles from the aspects of clinical research, and that the role of clinical research coordinator itself is not very familiar among staff in the facility. Some participants indicated that even their more senior coworkers have limited recognition about clinical research coordinators. Conclusion: There are few reports that deal with awareness-spreading activities that targeted facility staff in positions other than those related to clinical research. This type of education could be considered to more quickly build support of clinical research