治験コーディネーターが抱えるストレスの要因分析ならびに精神健康度との関連調査

抄録

The work of clinical research coordinators (CRCs) is extremely important and requires both interpersonal skills and high expertise. While the work is rewarding, it can also produce significant tension and burden. The stress felt by CRCs has not been reliably investigated in previous studies, and stress scales specific for this occupational category do not exist. Therefore, we designed a tool for CRC stress measurement (CRC stress management scale) to better discern the mental health status of CRCs and to standardize the measurement of stress levels in this group. In this study, the stress scale, an attribute investigation form, and the Japanese version of self-rating depression scale (SDS) were distributed to participating CRCs, and 288 responses were obtained (representing a 57.6% recovery rate). Five factors were extracted from the newly created 50-item stress scale by exploratory factor analysis. All the identified factors had α of 0.75 and above. The questions constituting each factor displayed a reasonable internal consistency. Furthermore, scores on the CRC stress scale and the Japanese version of SDS showed a positive correlation. In conclusion, the CRC stress management scale was found to be useful for the analysis of mental health specifically related to CRCs. (Jpn J Clin Pharmacol Ther 2013; 44(1): 37-46)