Discussions on the quality control system of investigator initiated trials in the new circumstances
10.3760/cma.j.cn111325-20220420-00344
- VernacularTitle:研究者发起的临床研究项目质量控制体系探讨
- Author:
Fanfan SHI
1
;
Xiaoqin ZHOU
;
Ying CHEN
;
Wenjie YANG
;
Peng HUANG
;
Deying KANG
;
Fang LIU
;
Lei CHEN
Author Information
1. 四川大学华西医院，成都 610041
- Keywords:
Total quality management;
Scientific research management;
Investigator initiated trials;
Quality control
- From:
Chinese Journal of Hospital Administration
2022;38(7):519-524
- CountryChina
- Language:Chinese
-
Abstract:
China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions, spotlighting the establishment and improvement of the quality control system of IIT projects than ever before. The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad, and by means of literature review analyzed the current quality management of IIT projects at home and abroad. They found such setbacks as lack of quality management standards and norms, imperfect quality control mechanism, poor awareness of quality risk, insufficient quality supervision and poor quality control ability of clinical researchers. Based on the above, the paper made the following recommendations for building an IIT project quality control system in China: developing quality management standards and norms, setting up a systematic quality control mechanism(i.e., exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team, and implementing the whole process quality control mechanism), strengthening policy guidance and system construction, and strengthening the standardized training of clinical researchers.
