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010   $a3-319-44344-5
024 7 $a10.1007/978-3-319-44344-7
035   $a(CKB)3710000000952846
035   $a(DE-He213)978-3-319-44344-7
035   $a(MiAaPQ)EBC4744027
035   $a(PPN)197140793
035   $a(EXLCZ)993710000000952846
100   $a20161115d2017      u|             0
101 0 $aeng
135   $aurnn#008mamaa
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aQuick Guide to Good Clinical Practice $b[electronic resource] $eHow to Meet International Quality Standard in Clinical Research /$fby Cemal Cingi, Nuray Bayar Muluk
205   $a1st ed. 2017.
210  1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2017.
215   $a1 online resource (XVIII, 237 p.)
311   $a3-319-44343-7 
320   $aIncludes bibliographical references.
327   $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.
330   $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.
606   $aPharmacy
606   $aStatistics 
606   $aSurgery
606   $aMedical education
606   $aDrug Safety and Pharmacovigilance$3https://scigraph.springernature.com/ontologies/product-market-codes/H69010
606   $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030
606   $aGeneral Surgery$3https://scigraph.springernature.com/ontologies/product-market-codes/H59044
606   $aMedical Education$3https://scigraph.springernature.com/ontologies/product-market-codes/O26000
615  0$aPharmacy.
615  0$aStatistics .
615  0$aSurgery.
615  0$aMedical education.
615 14$aDrug Safety and Pharmacovigilance.
615 24$aStatistics for Life Sciences, Medicine, Health Sciences.
615 24$aGeneral Surgery.
615 24$aMedical Education.
676   $a353.998
700   $aCingi$b Cemal$4aut$4http://id.loc.gov/vocabulary/relators/aut$0788865
702   $aBayar Muluk$b Nuray$4aut$4http://id.loc.gov/vocabulary/relators/aut
906   $aBOOK
912   $a9910151663203321
996   $aQuick Guide to Good Clinical Practice$92516855
997   $aUNINA