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Record Nr. |
UNINA9910784640803321 |
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Autore |
DeRenzo Evan G |
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Titolo |
Writing clinical research protocols [[electronic resource] ] : ethical considerations / / Evan G. DeRenzo and Joel Moss |
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Pubbl/distr/stampa |
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Burlington, MA ; ; London, : Elsevier Academic, c2006 |
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ISBN |
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1-280-63341-7 |
9786610633418 |
0-08-045420-8 |
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Edizione |
[Second edition.] |
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Descrizione fisica |
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1 online resource (321 p.) |
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Altri autori (Persone) |
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Disciplina |
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Soggetti |
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Clinical trials |
Medical protocols |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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. |
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Sommario/riassunto |
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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 |
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