Standard No.:	T/CGCPU 026-2023
English Name:	Design specifications for clinical trial protocol of cardiovascular interventional medical devices
Chinese Name:	心血管介入类医疗器械临床试验方案设计规范
Professional Classification:	T/    Social Organization Standard
Source Content Issued by:	GCP Union
Issued on:	2023-12-31
Implemented on:	2024-1-16
Status:	valid
Target Language:	English
File Format:	PDF

心血管介入类医疗器械临床试验方案设计标准涵盖临床试验全过程，包括试验的设计、实施、监查、稽查、检查以及数据的采集、记录、保存、分析，试验总结和报告等。为提升心血管介入类医疗器械临床试验的质量，保护受试者安全和权益，制定本文件。