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Titlebook: Quick Guide to Good Clinical Practice; How to Meet Internat Cemal Cingi,Nuray Bayar Muluk Book 2017 Springer International Publishing Switz

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发表于 2025-3-21 16:22:48 | 显示全部楼层 |阅读模式
书目名称Quick Guide to Good Clinical Practice
副标题How to Meet Internat
编辑Cemal Cingi,Nuray Bayar Muluk
视频video
概述Offers a comprehensive overview of the latest GPC regulations.A valuable guide, written by clinicians for clinicians.Includes an examination and comparison of American and European regulations
图书封面Titlebook: Quick Guide to Good Clinical Practice; How to Meet Internat Cemal Cingi,Nuray Bayar Muluk Book 2017 Springer International Publishing Switz
描述.This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). .The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols..Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies..
出版日期Book 2017
关键词Clinical study; Clinical research; Clinical Trial Protocols; Clinical trial ethics; International Confer
版次1
doihttps://doi.org/10.1007/978-3-319-44344-7
isbn_softcover978-3-319-44343-0
isbn_ebook978-3-319-44344-7
copyrightSpringer International Publishing Switzerland 2017
The information of publication is updating

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发表于 2025-3-21 21:14:13 | 显示全部楼层
Clinical Trials: Historical Aspects and Importance and New Drug Developments,A clinical study is conducted for researches in human volunteers (also called participants) to achieve medical knowledge. Clinical studies can be done as clinical trials (interventional studies) or observational studies [1].
发表于 2025-3-22 02:14:13 | 显示全部楼层
The Principles of GCP,‘Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirement(s)’.
发表于 2025-3-22 05:50:16 | 显示全部楼层
Preparation of Ethics Committee (IRB) Proposal,The ethics committee is responsible for reviewing a number of trial-related documents and giving their approval (or in some cases favourable opinion) before a study starts. Usually, the local IEC (or IRB in some countries) must be consulted [1].
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Monitoring the Trial,‘The purposes of trial monitoring are to verify that’:
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发表于 2025-3-23 07:52:04 | 显示全部楼层
https://doi.org/10.1007/978-3-319-44344-7Clinical study; Clinical research; Clinical Trial Protocols; Clinical trial ethics; International Confer
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