Clinical Research Coordinators' Attitude Toward Risk-Based Monitoring.

ABSTRACT

BACKGROUND: Clinical research coordinators (CRCs) are persons who collect, record, and maintain clinical trial data in accordance with the principles of Good Clinical Practice at investigators' sites. This study was conducted to examine attitudes of clinical research coordinators (CRCs) toward risk-based monitoring (RBM) prior to full-scale implementation of RBM in Korea. METHODS: The study subjects were 607 CRCs, and data were collected using a self-reported questionnaire. Collected data were analyzed by frequency, percentage, χ2 test and Fisher exact test. RESULTS: Among CRCs, 42.3% had heard of RBM and 44.6% were found to oppose its implementation. Those opposed believed that implementation of RBM would increase the workload of CRCs and CRAs' work support for CRCs. In addition, they showed many negative opinions such as poor accuracy of test data input and failure to increase the overall quality of clinical tests. In particular, such attitudes were more noticeable in CRCs with 5 or more years of experience. CONCLUSION: Before the implementation of RBM, it is necessary to come up with administrative measures such as education for practitioners and recruitment of human resources to help CRCs properly understand RBM.