000			03713nam a22004935i 4500
001			60184
005			20200226102542.0
007			cr nn 008mamaa
008			161115s2017 gw | s |||| 0|eng d
020			_a9783319443447 _9978-3-319-44344-7
024	7		_a10.1007/978-3-319-44344-7 _2doi
035			_a(DE-He213)978-3-319-44344-7
050		4	_aRS1-441
072		7	_aMMG _2bicssc
072		7	_aMED071000 _2bisacsh
082	0	4	_a353.998 _223
100	1		_aCingi, Cemal. _eauthor.
245	1	0	_aQuick Guide to Good Clinical Practice _h[electronic resource] : _bHow to Meet International Quality Standard in Clinical Research / _cby Cemal Cingi, Nuray Bayar Muluk.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2017.
300			_aXVIII, 237 p. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
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			_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		0	_aMedicine.
650		0	_aSurgery.
650		0	_aPharmacy.
650		0	_aMedical education.
650		0	_aStatistics.
650	1	4	_aMedicine & Public Health.
650	2	4	_aDrug Safety and Pharmacovigilance.
650	2	4	_aStatistics for Life Sciences, Medicine, Health Sciences.
650	2	4	_aGeneral Surgery.
650	2	4	_aMedical education.
700	1		_aBayar Muluk, Nuray. _eauthor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783319443430
856	4	0	_uhttp://dx.doi.org/10.1007/978-3-319-44344-7
912			_aZDB-2-SME
999			_c6808 _d6808