药品临床研究的良好实践准则

English | 2024 | ISBN: 9781003407010 | 207 pages | True PDF | 3.45 MB

Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.

Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted. Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice. Discusses applicable laws and regulations supporting GCP compliance, quality and operations. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.

良好的临床实践（GCP）是一套国际公认的伦理和科学质量要求，必须在设计、执行、记录和报告涉及人类参与者的试验时遵循。遵守GCP可保证患者及公众了解到，在研究中参加的人的权利、安全与福祉受到保护，并且研究数据是可靠的。 概述了GCP，这是所有临床研究都应遵循的国际伦理、科学和技术标准。 提供了最新的最佳实践方法、技术和操作方法，以确保临床试验的数据生成和报告符合方案要求。 讨论了支持GCP合规性、质量和运营的相关适用法律和规定。 描述了负责实施并维护质量保证与质量控制体系的人，以确保研究按照计划进行且数据得到记录和报告。

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