Exploration of Investigator-Initiated Clinical Trials human genetic resource administration in a large hospital
10.3760/cma.j.cn113565-20220214-00021
- VernacularTitle:某大型医院研究者发起的临床研究人类遗传资源管理探索
- Author:
Lihan XING
1
;
Xu ZUO
;
Yue LI
;
Yan CUI
Author Information
1. 首都医科大学附属北京友谊医院科技处，北京 100050
- Keywords:
Human genetic resources;
Investigator Initiated Clinical Trial;
Large hospitals
- From:
Chinese Journal of Medical Science Research Management
2022;35(3):175-179
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The management system of Investigator Initiated Clinical Trials (IIT) using human genetic resources in large hospitals is still not optimal. The purpose of this study is to sort out the existing problems of human genetic resources management in IIT of large hospitals, analyze the management practices, and provide reference for the standardized management of human genetic resources in IIT.Methods:The existing problems of human genetic resources management in IIT of large hospitals were sorted out by literature analysis, and the management practices since the establishment of human genetic resources management office were analyzed, and suggestions were put forward.Results:The problems of human genetic resources management in IIT of large hospitals mainly focused on the lack of awareness and attention of investigators and managers, the lack of process supervision, and the imbalance between input and output of genetic resources. A large hospital has implemented personnel and system construction, strengthened node management and control, and developed a training system. The approval rate of administrative approval and archival projects of human genetic resources of the Ministry of Science and Technology in 2021 increased by 52.69% compared with the previous year.Conclusions:Large hospitals should proceed from the actual situation, establish the human genetic resource management system jointly through multi-department linkage, improve management process, strengthen quality control, increase training efforts, improve the professional capacity and quality of researchers and managers, promote the high-quality, high-level and well development of IIT.
