Establishment of a Competency Training Curriculum System for Clinical Research Coordinators in Drug GCP Trials Based on the Iceberg Theory

Objective To establish a clinical research coordinator (CRC) curriculum system that aligns with Chinese good clinical practice (GCP) and the developmental needs of clinical trials, thereby providing a reference for the standardized and professional training of CRCs. Methods Through literature review and interview-based research, the competency evaluation indicator system and curriculum system of CRCs under domestic and international GCP frameworks were reviewed and synthesized. The Delphi method was used to consult 37 experts in the field of clinical research, forming a competency training curriculum system for CRCs in China. Results A CRC competency training curriculum system was established, which includes 9 competencies and 12 courses. Among these, the “above-iceberg”covers 6 competencies (e.g., “professional knowledge”and“learning and comprehension ability”) corresponding to 9 courses; the“below-iceberg”includes 3 competencies（e. g.,“integrity, compliance, and law-abiding”) corresponding to 3 courses. Across three rounds of consultation, the expert response rates were 100.0%, 97.3%, and 100.0%, respectively. The expert authority coefficients were 0.850, 0.875, and 0.925, and the coordination coefficients for the primary indicators were 0.348 and 0.414, while those for secondary indicators were 0.402, 0.432, and 0.521, respectively. Conclusion Based on the iceberg theory, this study constructed a CRC competency training curriculum system that addresses both explicit and implicit competencies, and can provide a useful reference for promoting the standardization of the CRC training system.