Exploration of a management model of quality control for drug clinical trials in hematology department
10.3760/cma.j.cn113565-20240529-00131
- VernacularTitle:血液科专业组药物临床试验质量控制管理模式的探索
- Author:
Shushu XU
1
;
Jia CHENG
1
;
Xiang ZHANG
1
Author Information
1. 国家血液系统疾病临床医学研究中心 苏州大学附属第一医院，苏州 215006
- Publication Type:Journal Article
- Keywords:
Drug clinical trials;
Quality control;
Department of hematology
- From:
Chinese Journal of Medical Science Research Management
2024;37(6):514-518
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to explore a new model of quality control management for drug clinical trials in the hematology department to ensure the quality of clinical trials of new drugs for hematologic disorders.Methods:Given the complexity and severity of hematologic diseases and various issues currently existing in clinical study, the hematology department of First Affiliated Hospital of Soochow University established a quality control management model based on the characteristics of hematology and department management system.Results:The department set up a working group to build a quality control management system for the hematology specialty group through a series of measures, including establishing a quality control group, setting up quality control checkpoints, standardizing the quality control process, formulating quality control forms, etc.Conclusions:Establishing an effective quality control management model could help improve the implementation level of researchers and the quality of clinical trials.
