Analysis of common quality problems for centralized monitoring of clinical research initiated by pediatric investigators
10.3760/cma.j.cn113565-20230426-00121
- VernacularTitle:研究者发起的儿科临床研究项目中心化监查常见质量问题分析
- Author:
Jinxia WANG
1
;
Hongyang ZHANG
;
Ziyang CAO
;
Zijun YAN
;
Chunxia WANG
;
Lin ZOU
Author Information
1. 上海市儿童医院/上海交通大学医学院附属儿童医院 临床研究中心 上海交通大学医学院儿童感染免疫与重症医学研究院 200062
- Keywords:
Investigator-Initiated Trail;
Pediatrics;
Quality Assurance;
Centralized monitoring
- From:
Chinese Journal of Medical Science Research Management
2023;36(5):384-388
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To standardize the management of pediatric Investigator-Initiated Trails (IIT) and improve the execution quality, this study takes a tertiary hospital for children in Shanghai as an example to analyze and summarize the main quality problems in the implementation of pediatric IIT projects and provide appropriate suggestions.Methods:From 2020 to 2022, based on the quality indicators of the IIT project of Shanghai Jiao Tong University School of Medicine, and combined with the characteristics of pediatrics, a centralized monitoring method was used to conduct spot checks and evaluations on the IIT project of a tertiary hospital for children in Shanghai.Results:From 2020 to 2022, a total of 77 IIT projects were inspected, including 27 in the initiation stage, 36 in the execution stage, and 14 in the conclusion stage. In terms of ethical compliance, there are issues with researchers′ weak ethical awareness and non-standard signing of informed consent in the pediatric IIT project. The main problems in terms of execution quality and science include non-standard CRF table design, insufficient awareness of safety management, lack of emphasis on research registration and specialized data management, randomization and blind methods. There are issues with low enrollment rate and low funding execution rate in terms of execution progress.Conclusions:There are certain quality problems during the execution of pediatric IIT projects. Strengthen the establishment of an effective process management and supervision system to improve the quality management of pediatric IIT research processes is needed.
