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Writing clinical research p...
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
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monografia Rebiun25952571 https://catalogo.rebiun.org/rebiun/record/Rebiun25952571 m o d cr cn||||||||| 070806s2006 mau ob 001 0 eng d 76697795 85766756 441762043 505064176 647545036 701878860 814467746 823136810 843151739 961552298 962560748 1162253939 9780122107511 0122107519 0080454208 electronic bk.) 9780080454207 electronic bk.) 1280633417 9781280633416 9786610633418 661063341X 9780122107511 UCH ocn162571734 UAO ocn162571734 UCEU ocn162571734 90127:90127 Elsevier Science & Technology http://www.sciencedirect.com OPELS eng pn OPELS OKU OCLCQ N$T YDXCP OCLCO EBLCP MHW MERUC UKWOH IDEBK UBY E7B OCLCQ OCLCF OCLCQ NLGGC CHVBK NRU OCLCQ AGLDB STF CCO MOR PHUST OCLCO IQW JBG OCLCO PIFAG ZCU OCLCQ CASUM OCLCO U3W OCLCA MNS OCLCO KIJ WRM VNS OCLCO D6H OCLCO ACO WCO OCLCO OCLCQ VTS OCLCO NRAMU XOS ICG OCLCO OCLCQ VT2 REC OCLCO AU@ OCLCO OCLCQ OCLCO WYU OCLCO S9I TKN OCLCO LEAUB OCLCO DKC OCLCO OCLCQ OCLCO M8D OCLCO OL$ OCLCQ OCLCO OCLCQ K6U OCLCA VLY HEA 032000 bisacsh MED 034000 bisacsh HEA 009000 bisacsh OCC 011000 bisacsh MJ bicssc DeRenzo, Evan G. Writing clinical research protocols ethical considerations Evan G. DeRenzo and Joel Moss Burlington, MA London Elsevier Academic ©2006 Burlington, MA London Burlington, MA London Elsevier Academic 1 online resource (xix, 300 pages) 1 online resource (xix, 300 pages) Text txt rdacontent computer c rdamedia online resource cr rdacarrier data file rda Includes bibliographical references and index Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience What You Need To Know About Research Ethics Before Deciding on What You Want To Study -- Designing a Clinical Research Study -- Writing Consent and Assent Documents -- Getting the Protocol Approved -- Conducting the Study; Special Populations -- Ethical Considerations in Genetics Research -- Ethical Considerations in Use of Tissue for Laboratory Investigations -- Ethical Considerations in Use of Stored Tissue -- Confidentiality Issues -- Research in Emergency Medicine -- Reporting of Adverse Events -- FDA -- Radiation Safety Issues -- Participation of Subjects in Multi-Site Trials -- Participation of Subjects in Multiple Studies -- Conduct of Pharmaceutical Industry Research -- Case Histories, Learning from Experience -- Appendix This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations English Clinical trials Biology- research Clinical Trials Human Experimentation Clinical Protocols Writing Ethics Biomedical Research- ethics Clinical Protocols- standards Études cliniques HEALTH & FITNESS- Alternative Therapies MEDICAL- Healing HEALTH & FITNESS- Healing BODY, MIND & SPIRIT- Healing- General Clinical trials Electronic books Electronic information resources [MESH] Electronic information resources Moss, Joel Print version DeRenzo, Evan G. Writing clinical research protocols. Burlington, MA ; London : Elsevier Academic, ©2006 9780122107511 0122107519 (OCoLC)56453025