Quick guide to good clinical practice : how to meet international quality standard in clinical research /

Quick guide to good clinical practice : how to meet international quality standard in clinical research /

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Bibliographic Details
Author / Creator:	Cingi, Cemal.
Imprint:	Cham, Switzerland : Springer, [2016], ©2017.
Description:	1 online resource
Language:	English
Subject:	Clinical trials. Biomedical Research. Clinical Trials Data Accuracy. Ethics, Research. Internationality. Total Quality Management -- standards. HEALTH & FITNESS -- Holism. HEALTH & FITNESS -- Reference. MEDICAL -- Alternative Medicine. MEDICAL -- Atlases. MEDICAL -- Essays. MEDICAL -- Family & General Practice. MEDICAL -- Holistic Medicine. MEDICAL -- Osteopathy. Clinical trials. Electronic books.
Format:	E-Resource Book
URL for this record:	http://pi.lib.uchicago.edu/1001/cat/bib/11268981

Hidden Bibliographic Details
Other authors / contributors:	Muluk, Nuray Bayar.
ISBN:	9783319443447 3319443445 9783319443430 3319443437
Notes:	Includes bibliographical references. Print version record.
Summary:	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.
Other form:	Print version: 3319443437 9783319443430

Table of Contents:

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.