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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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].

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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)’.

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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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https://doi.org/10.1007/978-3-319-44344-7Clinical study; Clinical research; Clinical Trial Protocols; Clinical trial ethics; International Confer