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| 020 | _a9780123821676 (electronic bk.) | ||
| 020 | _a0123821673 (electronic bk.) | ||
| 020 | _a9780123821683 (electronic bk.) | ||
| 020 | _a0123821681 (electronic bk.) | ||
| 020 | _z9780123821676 (hbk.) | ||
| 020 | _z0123821673 (hbk.) | ||
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| 050 | 4 | _aR850 | |
| 082 | 0 | 4 |
_a616.0072 _223 |
| 049 | _aTEFA | ||
| 245 | 0 | 0 |
_aPrinciples and practice of clinical research _h[recurso electrónico] / _cedited by John I. Gallin, Frederick P. Ognibene. |
| 250 | _a3rd ed. | ||
| 260 |
_aLondon : _bElsevier/Academic Press, _c2012. |
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| 300 |
_a1 online resource (xv, 780 pages) : _billustrations |
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| 336 |
_atext _btxt _2rdacontent |
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| 337 |
_acomputer _bc _2rdamedia |
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| 338 |
_aonline resource _bcr _2rdacarrier |
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| 504 | _aIncludes bibliographical references and index. | ||
| 520 | _aThe third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical ResearchAddresses the vast opportunities for translation of basic science observations to the bedside through clinical researchDelves into data management and addresses how to collect data and use it for discoveryContains valuable, up-to-date information on how to obtain funding from the federal government. | ||
| 505 | 0 | _a.A Historical Perspective on Clinical Research -- ETHICAL, REGULATORY, AND LEGAL ISSUES -- Ethical Principles in Clinical Research -- Researching a Bioethical Question -- Integrity in Research: Individual and Institutional Responsibility -- Institutional Review Boards -- Data and Safety Monitoring Boards -- Data Management in Clinical Trials -- Unanticipated Risks in Clinical Research -- The Regulation of Drugs and Biological Products by the Food and Drug Administration -- Legal Issues -- Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research -- National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research -- Clinical Research: A Patient Perspective -- The Clinical Researcher and the Media -- BIOSTATISTICS AND EPIDEMIOLOGY -- An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation -- Design and Conduct of Observational Studies and Clinical Trials -- Small Clinical Trials -- Large Clinical Trials and Registries -- Clinical Research Institutes -- Using Secondary Data in Statistical Analysis -- An Introduction to Survival Analysis -- Measures of Function and Health-Related Quality of Life -- TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES -- Overview of Technology Development -- Technology Transfer -- Writing a Protocol -- Evaluating a Protocol Budget -- Data Management in Clinical Research: General Principles and a Guide to Sources -- Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process -- Clinical Research from the Industry Perspective -- Human Genome Project, Genomics, and Clinical Research. | |
| 588 | 0 | _aPrint version record. | |
| 650 | 0 |
_aClinical medicine _xResearch. |
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| 650 | 0 |
_aClinical medicine _xResearch _xMethodology. |
|
| 650 | 2 |
_aResearch _xmethods. |
|
| 650 | 2 |
_aBiomedical Research _xmethods. |
|
| 650 | 1 | 3 | _aresearch methods. |
| 650 | 1 | 3 | _abiomedical research. |
| 650 | 4 | _aClinical research. | |
| 650 | 4 |
_aResearch _xMethods. |
|
| 650 | 4 | _aMedicine. | |
| 650 | 7 |
_aHEALTH & FITNESS _xDiseases _xGeneral. _2bisacsh |
|
| 650 | 7 |
_aMEDICAL _xClinical Medicine. _2bisacsh |
|
| 650 | 7 |
_aMEDICAL _xDiseases. _2bisacsh |
|
| 650 | 7 |
_aMEDICAL _xEvidence-Based Medicine. _2bisacsh |
|
| 650 | 7 |
_aMEDICAL _xInternal Medicine. _2bisacsh |
|
| 650 | 7 |
_aClinical medicine _xResearch. _2fast _0(OCoLC)fst00864379 |
|
| 650 | 7 |
_aClinical medicine _xResearch _xMethodology. _2fast _0(OCoLC)fst00864381 |
|
| 655 | 4 | _aElectronic books. | |
| 700 | 1 | _aGallin, John I. | |
| 700 | 1 | _aOgnibene, Frederick P. | |
| 776 | 0 | 8 |
_iPrint version: _tPrinciples and practice of clinical research. _dOxford : Academic, 2012 _z9780123821676 _w(OCoLC)778325833 |
| 856 | 4 | 0 |
_zLibro electrónico _3ScienceDirect _uhttp://148.231.10.114:2048/login?url=http://www.sciencedirect.com/science/book/9780123821676 |
| 596 | _a19 | ||
| 942 | _cLIBRO_ELEC | ||
| 999 |
_c207497 _d207497 |
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