Quick guide to good clinical practic...
Cingi, Cemal.

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  • Quick guide to good clinical practice = how to meet international quality standard in clinical research /
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Quick guide to good clinical practice/ by Cemal Cingi, Nuray Bayar Muluk.
    其他題名: how to meet international quality standard in clinical research /
    作者: Cingi, Cemal.
    其他作者: Muluk, Nuray Bayar.
    出版者: Cham :Springer International Publishing : : 2017.,
    面頁冊數: xviii, 237 p. :ill., digital ;24 cm.
    內容註: 1 Clinical Trials: Historical Aspects and Importance and New Drug Developments -- 2 The Definition of GCP -- 3 The Principles of GCP -- 4 The Drug Development Process and Evolution of Regulations -- 5 Planning Clinical Research -- 6 Preparation of Ethics Committee (IRB) Proposal -- 7 Preparation of Informed Consent -- 8 Preparation of Findings Tables -- 9 Setting the Ideal Statistical Methods -- 10 The Duties of a Clinical Research Coordinator -- 11 The Duties of Clinical Researchers -- 12 The Phases of Clinical Studies -- 13 Safety in Clinical Trials -- 14 Setting the Size -- 15 Setting the Ideal Method -- 16 Ethics of Clinical Research -- 17 Recruitment and Enrolment -- 18 Why we need Clinical Consent and Other Documentation -- 19 Monitoring the Trial -- 20 Inspection -- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC) -- 22 Responsibilities of the Investigator -- 23 Responsibilities of the Sponsor -- 24.Clinical Trial Protocols.
    Contained By: Springer eBooks
    標題: Clinical trials. -
    電子資源: http://dx.doi.org/10.1007/978-3-319-44344-7
    ISBN: 9783319443447
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