Research on standardized management measures for the implementation process of Investigator-Initiated Trials: taking Beijing Tiantan Hospital, Capital Medical University as an example
10.3760/cma.j.cn113565-20250123-00023
- VernacularTitle:研究者发起的临床研究实施过程规范化管理措施研究
- Author:
Chunli PEI
1
;
Lingling XU
;
Xuejiao LI
;
Xin ZHAO
;
Jing LI
;
Jingjing WU
;
Hao WANG
;
Beibei XU
Author Information
1. 首都医科大学附属北京天坛医院国家神经疾病医学中心办公室，北京 100070
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trial;
Project process management;
Standardized management
- From:
Chinese Journal of Medical Science Research Management
2025;38(3):252-259
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To standardize the management of Investigator-Initiated Trials(IITs) and improve the quality of research projects, this study takes a tertiary hospital in Beijing as an example to analyze the key risk points in the implementation process of IITs and proposes countermeasures based on the issues identified during the management process.Methods:The study analyzed the IITs conducted at in the hospital from 2022 to 2023, focusing on 4 aspects: project classification evaluation and management (risk management), project implementation quality (process management), collaboration and support conditions(contract review and execution), and participant protection (medical ethics). It examined the key points and difficulties in project process management to standardize the quality management of IITs.Results:The implementation process management of IITs in medical institutions was an essential component for standardized clinical research management and an effective means to ensure the scientific nature of clinical research and the quality of data.Conclusions:Medical institutions should establish an effective and feasible IIT quality management system to comprehensively enhance the quality of IIT project, aiming to produce high-quality clinical research outcomes.
