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.
Inhaltsverzeichnis
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.
Über den Autor
Cemal Cingi, MD, is a Professor in the Otorhinolaryngology Department at Eskisehir Osmangazi University, Medical Faculty, Eskisehir, Turkey. He graduated from the School of Medicine, Istanbul University in 1984 and then entered the Otorhinolaryngology Residency Programme at Anadolu University, Eskisehir, becoming a Specialist in ORL & HNS in 1990. He was appointed as an Associate Professor in 1995 and as a Professor in 2001. In 2013 he became an accredited Specialist in Mouth, Face, and Chin Surgery. Dr. Cingi is Chair of the ENT Section of the European Academy of Allergy and Clinical Immunology (EAACI) and President of the Asian Facial Plastic Surgery Society (AFPSS). He is editor of Journal of Medical Updates and an editorial board member for several other journals. Dr. Cingi is the author or editor of seven previous books.
Dr. Nuray Bayar Muluk is currently professor of Ear, Nose and Throat at Kirikkale University, Medical Faculty in Turkey. Author of12 book chapters and more than 120 published papers, She is working on many different fields of ENT such as Head and Neck Cancer, Tinnitus, Laryngology, Rhinology, Aesthetic Surgery.
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