Based on the previously established competency model for clinical investigators in drug clinical trials, this study aims to evaluate the effectiveness of a targeted training program, clarify the role of this model in improving investigators’ professional competence, operational skills, and ethical awareness, and provide evidence-based basis for the precise optimization of clinical trial training models.

Investigators from tertiary Grade A hospitals in Beijing who had participated in at least one clinical trial in the past three years were selected as the research subjects. The training content was designed based on the core elements of the competency model. A pre-training and post-training paired design was adopted to evaluate the improvement of knowledge and skills through standardized Good Clinical Practice (GCP) simulation tests; online questionnaire surveys were conducted to collect trainees’ satisfaction feedback on training content, teaching quality, organizational management and other dimensions. Wilcoxon signed-rank test was used to compare scores before and after training. Stratified by gender, the Mann-Whitney U test was used to compare the inter-group differences in post-training competency scores of investigators of different genders. Stratified by educational background, professional title and working years of clinical trial practice, the Kruskal-Wallis H test was adopted to analyze the inter-group differences in post-training scores among investigators with different educational levels, different professional titles, and different working years.

A total of 81 clinical investigators were included, with a median age of 34 (31.00, 44.00) years. The proportions of males and females were 27.16% and 72.84%, respectively. Among the participants, 62.96% held doctoral degrees, and 32.10% had senior professional titles. The median pre-training total score (Q1, Q3) was 35.00 (31.00, 39.00) scores, while the median post-training total score (Q1, Q3) was 43.00 (40.00, 46.00) scores, indicating a significant improvement in the trainees’ total scores (Z=-7.30, P<0.001). The scores for all competency sub-dimensions increased significantly compared to those before training. Among them, the differences in scores before and after training for ethical awareness and subject protection, GCP implementation capability, study design and protocol execution, and data quality control were all statistically significant (all P<0.001). Subgroup analysis showed that the total competency scores of investigators with different genders, professional titles, and years of experience in clinical trials significantly improved after training, with no statistically significant differences in the magnitude of improvement between groups. Participants with master’s or doctoral degrees showed significant improvements in post-training scores (all P<0.001), while those with bachelor’s degrees showed no significant difference between pre- and post-training scores (P>0.05). Furthermore, 85.19% of the trainees rated the overall performance of the training as very satisfied.

The training program designed based on the competency model could improve the GCP theoretical level and practical knowledge reserve of clinical investigators in clinical trials, and has good trainee acceptance and practicality. By accurately matching the core competency needs of clinical investigators, this training model provides a replicable practical path for the optimization of the clinical trial talent training system.