1 Good Clinical Practice (GCP) Guidelines 1 I. Sponsor Responsibilities A. Quality Assurance and Quality Control B. Contract Research Organi zation (CRO) C. Medical Expertise D. Clinical Study Design E. Clinical Study Management, Data Handling, Recordkeeping, and Independent Data Monitori ng Board...
给大家整理了,中英文互译的药物临床试验质量管理规范【Good Clinical Practice (GCP)】 第一条 为保证药物临床试验过程规范,数据和结果的科学、真实、可靠,保护受试者的权益和安全,根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《中华人民共和国药品管理法实施条例》,制定本规范。本规范适用于为申请...
1、1藥品優良臨床試驗規範good clinical practice (gcp)林志六 醫師/律師博觀法律事務所2國內法規n藥品優良臨床試驗規範n85.11.20n91.9.20n藥品優良臨床試驗準則n94.1.63法規性質n藥品優良臨床試驗規範n行政指導n醫藥界之自律指引n國際醫藥法規協合會之ich e6n美國、歐盟、日本、世界衛生組織等地區之gcpn藥品優良...
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Good Clinical Practice Chapter 2, Section 3 GCP also provides unified, high-quality data to facilitate the mutual acceptance of clinical data by regulatory authorities of jurisdiction. As a result, comparable versions of food clinical practice guidelines, established by the World Health Organization, ...
850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* INTRODUCTION Glossary 1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL 1.1 Justification for the trial 1.2 Ethical principles 1.3 Supporting data for the investigational product 1.4 Investigator ...
内容提示: Good Clinical Practice Guidelines INTRODUCTION The history of Good Clinical Practice (GCP) statute traces back to one of the oldest enduring traditions in the history of medicine: The Hippocratic Oath. As the guiding ethical code it is primarily known for its edict to do no harm to ...
药物临床试验质量管理规范(GCP,Good Clinical Practice) 国家食品药品监督管理局令(第三号) 2003年9月1日起施行第一章 总则 第一条 为保证药物临床试验过程规范,结果科学可靠,保护受试者的权益并保障其安全,根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》,参照国际公认原则,制定本规范。
guideline for good clinical practice Guideline for Good Clinical Practice (GCP): Ensuring Ethical and Quality Clinical Trials Introduction: The Guideline for Good Clinical Practice (GCP) is an international ethical and scientific quality standard thatsets guidelines for designing, conducting, recording,...
Good Clinical Practice (GCP) guidelines share specific features, involve all stakeholders of clinical trials, and clarify their respective responsibilities. Accordingly, in this chapter, all aspects of GCP will be discussed in detail. Before conducting the trial, there are some requirements such as ...