Construction of a competency evaluation model for Clinical Research Coordinators in China: a study based on the Delphi method and questionnaire survey.

ABSTRACT

PURPOSE: As the number of clinical trials in China continues to grow, the assessment of competency of Clinical Research Coordinators (CRCs), who play a crucial role in clinical trials, has become an important and challenging topic. This study aims to construct a competency model for CRCs tailored to the Chinese context, in order to promote the standardisation and regulated development of the CRC industry. STUDY DESIGN AND SETTING: This study was conducted in China, engaging CRCs as the primary subjects. A competency evaluation model for CRCs was constructed through literature review, semi-structured interviews, Delphi expert consultation and the analytic hierarchy process. A questionnaire survey was distributed to a broad sample of CRCs across China to evaluate the model's reliability and validity. RESULTS: The final model encompasses 4 core competency dimensions and 37 indicators, tailored to assess the competencies of CRCs in China. The questionnaire yielded an effective response rate of 81.83%, with high internal consistency(Cronbach's α>0.7). Factor analysis confirmed the model's structure, indicating good reliability and validity. CONCLUSION: This study represents a pioneering effort in constructing a competency model specifically designed for Chinese CRCs, complemented by a robust and valid assessment scale. The findings bear significant implications for the recruitment, training, development and management of CRCs.