Strategy on improving quality of study of triazavirin for 2019 novel coronary pneumonia (COVID-19) with features of "core data targeted"
10.12092/j.issn.1009-2501.2020.10.013
- VernacularTitle: 特力阿扎维林治疗COVID-19临床研究的"核心数据靶向性"质控策略
- Author:
Jingshu GAO
1
Author Information
1. First Affiliated Hospital, Heilongjiang University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Core data;
COVID-19;
Quality control;
Targeting
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(10):1171-1177
- CountryChina
- Language:Chinese
-
Abstract:
With the spread of the new coronavirus pneumonia in China, medical researchers at home and abroad have carried out clinical studies in order to find the best way to combat the epidemic. The quality control measures are the key to ensure the scientificity of results. An overview of a multi-center randomized controlled double-blind clinical study was presented which was on the efficacy and safety of terazavirin in the treatment of COVID-19. It has pointed out that the difficulty of quality control in this study lies in obtaining the first-line data for the research assistant due to the isolation, and the delay of quality control only through the verification of EDC data. And these problems could be solved by using "core data targeting" quality control form. The features of this form include the concise content directly aiming at the main chart data in the research report for quality control, focusing on the implementation of the core elements of the programme and function of reminding and helping research assistants understand the capabilities of the project.
