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020 _a9783319546933
024 7 _a10.1007/978-3-319-54693-3
_2doi
040 _aES-MaUEC
_bspa
_dES-VaUE
050 4 _aR850
_b.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
_c2018
300 _a1 recurso en línea (XIX, 270 páginas 10 ilustraciones, 2 ilustraciones a color)
336 _2rdacontent
_aTexto (visual)
_btxt
337 _2rdamedia
_aelectrónico
_bc
338 _2rdacarrier
_arecurso electrónico
_bcr
347 _atext file
_bPDF
490 0 _aMedicine (Springer-11650)
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. .
988 _aEBSPRINGER_2018
650 7 _9138380
_aMedicina clínica
_2embne
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 Valencia)
942 _2lcc
_cLE
998 _db
_feng
_ggw
_h0