[Quality assurance in clinical studies: a necessity].

M Boll, J Binder, A Siegel, R Grundmann
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引用次数: 0

Abstract

Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) are the constituents of a new concept for quality assurance in pharmaceutical research. They are to establish standards for preclinical and experimental research in animals (GLP), for the manufacturing of drugs (GMP), and for trials on medical products in human beings (GCP), respectively. Each of the 3 entities is characterized by the same principles of control; these involve written instruction describing the general operations to be performed, the so called Standard Operating Procedures (SOP), and Quality Assurance Units being responsible for surveying the operations in accordance with the SOP, and ensuring that the generated data will satisfy the requirements for quality. As far as clinical trials are concerned, the SOP is represented by the study protocol and a Monitor provides for the surveying of the trial. GCP is further characterized by ethical principles, which aim primarily at protecting personal integrity and welfare of the trial subjects. The Declaration of Helsinki is the accepted basis for clinical trial ethics. Following the Declaration of Helsinki during the planning, conducting, surveying and evaluating of clinical trials provides for a degree of seriousness being the real hallmark of Good Clinical Practice.

[临床研究的质量保证:必要性]。
良好实验室规范(GLP)、良好生产规范(GMP)和良好临床规范(GCP)是药物研究质量保证新概念的组成部分。它们将分别为动物临床前和实验研究(GLP)、药物生产(GMP)和医疗产品人体试验(GCP)制定标准。这三个实体都具有相同的控制原则;这些包括描述一般操作的书面说明,所谓的标准操作程序(SOP),以及质量保证单位负责根据SOP调查操作,并确保生成的数据满足质量要求。就临床试验而言,SOP由研究方案代表,监测人员负责对试验进行调查。GCP进一步以伦理原则为特征,其主要目的是保护试验对象的个人诚信和福利。《赫尔辛基宣言》是临床试验伦理的公认基础。根据《赫尔辛基宣言》,在临床试验的规划、实施、调查和评价过程中规定了一定程度的严肃性,这是良好临床实践的真正标志。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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