عنوان

Clinical research :

1605477486 (alk. paper)

9781605477480 (alk. paper)

b516515

Clinical research :

[Book]

from proposal to implementation /

[edited by] Michael J. McPhaul, Robert D. Toto ; research ethics commentaries by Simon J. Craddock Lee and John Z. Sadler

Philadelphia :

Wolters Kluwer Health/Lippincott Williams & Wilkins,

c2011

xiii, 255 p. :

ill. ;

23 cm

Includes bibliographical references and index

How to launch a successful career in clinical research: tips on making the most of available resources / Robert D. Toto -- Institutional review board approval / Suzanne M. Rivera -- Writing informed consent documents and obtaining informed consent / Anne Clark, Suzanne M. Rivera, Diane Sheppard, Darren K. McGuire, and Michael J. McPhaul -- Ethics of data sharing and handling of genetic information / Bradley Malin, David Karp, and Richard Scheuermann -- Writing a statistical analysis plan / Beverley Adams-Huet and Chul Ahn -- Protocol implementation procedures / Tammy L. Lightfoot -- Screening and evaluation / Robert D. Toto -- Recruitment and retention / Tammy L. Lightfoot -- How to set up your database / Janet P.Smith -- Budgeting process and management / Deanna S. Adams -- Understanding Food and Drug Administration (FDA) regulatory requirements for investigational new drug applications (IND) for sponsor-investigators / M.E. Blair Holbein -- Collecting data / Deanna S. Adams -- Data and safety monitoring / Andrea M. Nassen -- Presenting, writing, and publishing challenges / Charles T. Quinn and A. John Rush

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"Clinical and translational research is a crucial link to the improvement of clinical care and practice. Many of the elements that are involved--physicians, nurses, pharmacists, laboratory testing, medical records--are also involved in the delivery of care to patients. Yet in the conduct of clinical research, these elements are arrayed in different configurations and constrained by rules and regulations that are distinct from those that guide the practice of medicine. In parallel with these considerations, the conduct of clinical research demands a specific skill set. Specialized tools are required to formulate and design informative clinical trials and to interpret the findings from such experiments"--Provided by publisher

Clinical trials

Biomedical Research-- methods

Clinical Trials as Topic-- methods

Research Design

McPhaul, Michael J

Toto, Robert D

20110331051751.0

[Book]

Y