000			03587cam a2200373Mi 4500
001			94889
003			ES-MaUEC
005			20230102112636.0
006			m o d
007			cr |n|||||||||
008			161118t20162017sz ob 000 0 eng d
020			_a3319443445 _q(electronic bk.)
020			_a9783319443447 _q(electronic bk.)
020			_z3319443437
020			_z9783319443430
035			_a(OCoLC)963745339 _z(OCoLC)964294858 _z(OCoLC)964530382
040			_aYDX _cYDX _dN$T _dIDEBK _dGW5XE _dOCLCQ _dOCLCF _dN$T _dAZU _dMERUC _dUAB _dIOG _dESU _dZ5A _dJBG _dIAD _dICW _dICN _dOTZ _dOCLCQ _dU3W _dES-MaUEC _bspa
050		4	_aR853.C55 _b2017 EB
100	1		_aCingi, Cemal. _eautor
245	1	0	_aQuick guide to good clinical practice : _bhow to meet international quality standard in clinical research _cCemal Cingi, Nuray Bayar Muluk.
264		1	_aCham, Switzerland _bSpringer International Publishing
300			_a1 recurso en línea
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
504			_aIncluye referencias bibliográficas
505	0		_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.
520	3		_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.
650		7	_aEnsayos clínicos _2embne _0(OCoLC)fst00864429 _0 _9144524
700	1		_aMuluk, Nuray Bayar.
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=http://link.springer.com/10.1007/978-3-319-44344-7 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
988			_aSpringer_Medicine_2017
998			_b02/2018 _dz _e- _zSI
999			_c94889 _d94889 _x1