论文部分内容阅读
承担研制新药临床研究的医院和有关保健机构及主要中心,必须保证对药物建立和执行安全使用的条例和程序。本文件提供有关原则和规定并对目前已在实施者予以评价。基本原则使用研制新药的程序应围绕下述基本原则来建立: 1.分担研制新药研究的医疗机构必须保证此类研究的本身、它的成员、研究的科学完整性,特别是对受试病例,必须具有足够的保护措施。为达此目的,有关机构应对研制新药的研
Committed to the development of new drug clinical research hospitals and related health institutions and major centers, we must ensure the safe use of drugs to establish and implement the rules and procedures. This document provides relevant principles and provisions and is currently being evaluated by the implementers. Fundamentals The procedure for using new drug development should be established around the following basic principles: 1. The sharing of the scientific body responsible for the development of a new drug must ensure the scientific integrity of the study itself, its members, and its research, in particular, Must have adequate protection. To this end, the relevant agencies should deal with research and development of new drugs