id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-280093-w71e0ex9	Jung, So-Young	Monitoring in clinical trials of complementary and alternative medicine	2020-09-23		.txt	text/plain	2250	129	45	BACKGROUND: 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. Monitoring in the context of a clinical trial entails many types of systematic activity to ensure that the study is conducted and data are acquired according to the planned protocol in compliance with Good Clinical Practice (GCP) and relevant legislation. The main roles of a monitor are defined by GCP, and are classified according to the principal purpose of monitoring as follows: first, they must ensure protection of human rights during the trial by checking that all study participants have provided written informed consent; second, they must ensure that the data collected are accurate and complete by checking the source documents; and third, they must confirm whether or not the study is conducted Essential documents for evaluation of trial conduct and the quality of the study data according to ICH-GCP 2 need to be updated and kept secure in the research institution and sponsor site in a timely manner.	./cache/cord-280093-w71e0ex9.txt	./txt/cord-280093-w71e0ex9.txt