Writing clinical research protocols[...
DeRenzo, Evan G.

 

  • Writing clinical research protocols[electronic resource] :ethical considerations /
  • 紀錄類型: 書目-語言資料,印刷品 : Monograph/item
    杜威分類號: 615.50724
    書名/作者: Writing clinical research protocols : ethical considerations // Evan G. DeRenzo and Joel Moss.
    作者: DeRenzo, Evan G.
    其他作者: Moss, Joel.
    出版者: Burlington, MA ; : Elsevier Academic,, c2006.
    面頁冊數: xix, 300 p. ;; 23 cm.
    標題: Clinical trials.
    標題: Clinical Protocols.
    標題: Ethics.
    標題: Writing.
    標題: Biomedical Research - ethics.
    標題: �Etudes cliniques.
    ISBN: 9780122107511
    ISBN: 0122107519
    書目註: Includes bibliographical references and index.
    內容註: 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.
    摘要、提要註: 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.
    電子資源: An electronic book accessible through the World Wide Web; click for information
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