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001			99883
003			DE-He213
005			20230110040155.0
007			cr nn 008mamaa
008			180808s2018 gw | s |||| 0|eng d
020			_a9783319546933 _9
024	7		_a10.1007/978-3-319-54693-3 _2doi
040			_aES-MaUEC _bspa
050		4	_aR850 .E27 2018 EB
100	1		_aEast, Cara _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
245	1	0	_aDeveloping a Successful Clinical Research Program _cby Cara East.
264		1	_aCham, Switzerland _bSpringer International Publishing _c2018
300			_a1 recurso en línea (XIX, 270 páginas 10 ilustraciones, 2 ilustraciones a color)
336			_2rdacontent _aTexto _btxt
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_atext file _bPDF
505	0		_aWhy Do Clinical Research?- How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect -- Choosing Studies -- Starting Clinical Research -- Developing a Budget -- Negotiating a Contract -- Writing a Great Informed Consent (IC) -- Starting the Study -- Regulatory Startup -- Recruiting -- Getting Subjects through the Door -- The Screening Visit -- Follow-up Visits -- Maintaining Subject Retention and Avoiding Study Fatigue -- Adverse Events (AE's) and Protocol Deviations -- Contact Research Organizations (CRO's) and Monitors -- Annual Review and Financial Disclosures -- Finishing a Study -- Staff Training and Incentives -- Study Closeout -- Acing an Audit -- Expanding the Team -- Epilogue: Watching Medicine Evolve -- Appendices.
520	3		_aThis unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. .
650		7	_aMedicina clínica _2embne _9138380
710	2		_aSpringerLink (Online service) _0http://id.loc.gov/authorities/names/no2005046756 _0http://viaf.org/viaf/148105729 _9106996
776	0	8	_iEdición impresa: _z9783319546926
776	0	8	_iEdición impresa: _z9783319546940
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-319-54693-3 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
490	0		_aMedicine (Springer-11650)
988			_aSpringer_Medicine_2018
998			_b01/2019 _dz _ek _feng _ggw _h0
999			_c99883 _d99883 _x1