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000778019 019__ $$a964294858$$a964530382
000778019 020__ $$a9783319443447$$q(electronic book)
000778019 020__ $$a3319443445$$q(electronic book)
000778019 020__ $$z9783319443430
000778019 020__ $$z3319443437
000778019 035__ $$aSP(OCoLC)ocn963745339
000778019 035__ $$aSP(OCoLC)963745339$$z(OCoLC)964294858$$z(OCoLC)964530382
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000778019 049__ $$aISEA
000778019 050_4 $$aR853.C55
000778019 08204 $$a610.72/4$$223
000778019 1001_ $$aCingi, Cemal.
000778019 24510 $$aQuick guide to good clinical practice :$$bhow to meet international quality standard in clinical research /$$cCemal Cingi, Nuray Bayar Muluk.
000778019 260__ $$aCham, Switzerland :$$bSpringer,$$c[2016], ©2017.
000778019 300__ $$a1 online resource
000778019 336__ $$atext$$btxt$$2rdacontent
000778019 337__ $$acomputer$$bc$$2rdamedia
000778019 338__ $$aonline resource$$bcr$$2rdacarrier
000778019 504__ $$aIncludes bibliographical references.
000778019 5050_ $$a1 Clinical Trials: Historical Aspects and Importance and New Drug Developments -- 2 The Definition of GCP -- 3 The Principles of GCP -- 4 The Drug Development Process and Evolution of Regulations -- 5 Planning Clinical Research -- 6 Preparation of Ethics Committee (IRB) Proposal -- 7 Preparation of Informed Consent -- 8 Preparation of Findings Tables -- 9 Setting the Ideal Statistical Methods -- 10 The Duties of a Clinical Research Coordinator -- 11 The Duties of Clinical Researchers -- 12 The Phases of Clinical Studies -- 13 Safety in Clinical Trials -- 14 Setting the Size -- 15 Setting the Ideal Method -- 16 Ethics of Clinical Research -- 17 Recruitment and Enrolment -- 18 Why we need Clinical Consent and Other Documentation -- 19 Monitoring the Trial -- 20 Inspection -- 21 Ethics -- Institutional Review Board/Independent Ethics Committee(IRB/IEC) -- 22 Responsibilities of the Investigator -- 23 Responsibilities of the Sponsor -- 24.Clinical Trial Protocols.
000778019 506__ $$aAccess limited to authorized users.
000778019 520__ $$aThis brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard - Good Clinical Practice - provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
000778019 588__ $$aDescription based on print  version record.
000778019 650_0 $$aClinical trials.
000778019 7001_ $$aMuluk, Nuray Bayar.
000778019 77608 $$iPrint version:$$z3319443437$$z9783319443430$$w(OCoLC)953598443
000778019 852__ $$bebk
000778019 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://link.springer.com/10.1007/978-3-319-44344-7$$zOnline Access$$91397441.1
000778019 909CO $$ooai:library.usi.edu:778019$$pGLOBAL_SET
000778019 980__ $$aEBOOK
000778019 980__ $$aBIB
000778019 982__ $$aEbook
000778019 983__ $$aOnline
000778019 994__ $$a92$$bISE