Discussion of data problems and improvement measures in clinical trials: Based on CRC work assessment in a grade A tertiary hospital
10.3760/cma.j.cn113565-20220511-00078
- VernacularTitle:临床试验中的数据问题及改进措施探讨
- Author:
Fei LIU
1
;
Qingqing WANG
;
Haijuan ZHAO
;
Huiqing YAO
;
Miao MIAO
;
Yue LIU
;
Yanhui WANG
;
Xin WANG
Author Information
1. 北京医院临床试验研究中心 国家老年医学中心 中国医学科学院老年医学研究院 药物临床风险与个体化应用评价北京市重点实验室，北京 100730
- Keywords:
Clinical trials data;
Data integrity;
ALOCA+ Principle;
Clinical Research Coordinator
- From:
Chinese Journal of Medical Science Research Management
2022;35(6):416-420
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.
