Exploration and thinking on promoting investigator-initiated clinical research project management
10.3760/cma.j.cn113565-20240220-00049
- VernacularTitle:推动研究者发起的临床研究立项管理的探索与思考
- Author:
Weifeng LU
1
;
Lu XU
;
Ping ZHOU
;
Hongqian HUANG
;
Ping LIN
;
Song CHEN
;
Xinbao HAO
Author Information
1. 海南医学院第一附属医院临床研究中心，海口 570102
- Keywords:
Inginvestigator-initiated trial;
Project management;
Program optimization
- From:
Chinese Journal of Medical Science Research Management
2024;37(5):429-433
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore and think about the project management model of investigator-initiated trial (IIT), and the project management of industry sponsored trial (IST), we should standardize the management process of clinical research projects initiated by researchers, improve the management system of clinical research in medical institutions, improve the quality management level of clinical research, and protect the rights and interests of research participants.Methods:By taking the clinical research management of a medical and health institution in Hainan province as an example, one of the first pilot areas for the standardized management of clinical research by the National Health Commission, the difficulties in the management of clinical research initiated by researchers were sorted out, to analyze and standardize the management of clinical research project initiated by researchers.Results:Discussion Project management was the primary link and basic guarantee of standardized management of clinical research, and scientific and feasible project management was a powerful hand to carry out deep and high-quality IIT.Conclusions:It can be manifested in a Hainan provincial public medical institution that a feasible project management was the basement in carrying out the profound and high quality IIT. It is advicable to make full use of policy advantages and clinical resources to produce high-quality research results as well as build a high-level research hospital.
