The Resource Writing clinical research protocols : ethical considerations, Evan G. DeRenzo and Joel Moss

Writing clinical research protocols : ethical considerations, Evan G. DeRenzo and Joel Moss

Label
Writing clinical research protocols : ethical considerations
Title
Writing clinical research protocols
Title remainder
ethical considerations
Statement of responsibility
Evan G. DeRenzo and Joel Moss
Creator
Contributor
Subject
Language
eng
Summary
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
Cataloging source
OPELS
Dewey number
615.50724
Index
index present
LC call number
R853.P75
LC item number
D47 2006eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
Writing clinical research protocols : ethical considerations, Evan G. DeRenzo and Joel Moss
Publication
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • 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
Control code
ocn162571734
Dimensions
unknown
Extent
1 online resource (xix, 300 pages)
Form of item
online
Isbn
9780080454207
Media category
computer
Media MARC source
rdamedia
Media type code
c
http://library.link/vocab/ext/overdrive/overdriveId
90127:90127
http://library.link/vocab/recordID
.b36077392
Specific material designation
remote
System control number
  • (OCoLC)162571734
  • pebcs0080454208

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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