Jung So-Young, Kang Jung Won, Kim Tae-Hun
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
Integr Med Res. 2021 Jun;10(2):100666. doi: 10.1016/j.imr.2020.100666. Epub 2020 Sep 23.
Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM).
Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described.
In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM.
When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research.
临床试验监查是质量保证（QA）的一项重要活动，以确保人权得到保护以及数据收集过程的可靠性和透明度。本文旨在增进对补充和替代医学（CAM）临床试验监查过程及主要发现的理解。
基于人用药品注册技术要求国际协调会（ICH-GCP），我们总结了监查过程的主要概念。还叙述性地描述了在CAM研究监查方面的个人经验。
在这篇简短的文章中，提出了QA和质量控制（QC）的基本概念、研究过程中的各种监查活动以及关于CAM临床试验的主要发现，以努力增进对CAM临床研究监查的理解。
在进行与CAM相关干预措施的临床试验时，需要将GCP中推荐的监查视为CAM研究过程中的一项强制性要素。
