Current situation and management practice of qualified person system for stem cell clinical research in medical institutions
10.3760/cma.j.cn113565-20211231-00206
- VernacularTitle:医疗机构干细胞临床研究质量受权人制度的现状及管理实践
- Author:
Jigang ZHANG
1
;
Mingjian ZHANG
;
Pei CAO
;
Huichen HE
;
Yan ZHANG
;
Yanhong ZHU
;
Xingdong ZHENG
;
Xueying DING
Author Information
1. 上海交通大学医学院附属第一人民医院 200080
- Keywords:
Stem cell;
Qualified person;
Clinical research;
Management;
Specification
- From:
Chinese Journal of Medical Science Research Management
2022;35(6):401-405
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze and study the difficulties and countermeasures in the implementation of the Qualified Person(QP) system for stem cell clinical research, and share the experience of QP management practice in our hospital in order to promote and improve the construction of the QP management system in medical institutions.Methods:Comprehensive investigations were conducted to summarize and analyze the shortage of talents, unclear qualifications, unclear responsibilities, and lack of assessment standards in the QP system of medical institutions.Results:In view of the difficulties in the implementation of the current QP system, it is suggested to consider a combination of improving the system of laws and regulations, strengthening the top-level design of stem cell research institutions, clarifying the qualification threshold, refining QP responsibilities, continuing training and assessment system, establishing QP support system, etc.Conclusions:Medical institutions are responsible for stem cell clinical research, and the improvement of the QP system can promote the development of the cell industry in China.
