基于监管科学的临床试验机构质量风险可视化模型

Drug clinical trial institutions (GCP institutions) play a key role in clinical trials quality management (QM). At present, all sides of the industry are actively exploring scientific methods for GCP Institution ability evaluation. But existing studies mainly focus on the construction level assessment of GCP institutions. While the research on the QM ability evaluation is still ignored or insufficient. In this work, we briefly reviewed the stadies for QM ability evaluation of GCP institutions, discussed the existing basis for the evaluation of GCP institutions by regulatory authorities. Furthermore, from the perspectives of drug regulatory science and risk management, based on relevant regulations, we also explored a visualization model for the quality risk assessment in GCP institutions by semi-quantitative analysis.