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|Material Type:||Document, Internet resource|
|Document Type:||Internet Resource, Computer File|
|All Authors / Contributors:||
John I Gallin; Frederick P Ognibene
|Notes:||Rev. ed. of: Principles and practice of clinical research / John I. Gallin. San Diego, CA : Academic Press, 2002.|
|Description:||1 online resource (xvi, 430 p.) : ill.|
|Contents:||A historical perspective on clinical research / John I. Gallin --
Ethical principles in clinical research / Christine Grady --
Researching a bioethical question / Ezekiel J. Emanuel --
Integrity in research : individual and institutional responsibility / Joan P. Schwartz --
Institutional review boards / Alison Wichman --
Data and safety monitoring boards / Lawrence M. Friedman --
Data management in clinical trials / Anne Tompkins --
Unanticipated risk in clinical research / Stephen E. Straus --
The regulation of drugs and biological products by the food and drug administration / Kathryn C. Zoon and Robert A. Yetter --
Legal issues / Patricia A. Kvochak --
Rules to prevent conflict of interest for clinical investigators conducting human subjects research / Robert B. Nussenblatt and Michael M. Gottesman --
National Institutes of Health policy on the inclusion of women and minorities as subjects in clinical research / Miriam Kelty, Angela Bates, and Vivian W. Pinn --
Clinical research : a patient perspective / Susan Lowell Butler --
The clinical researcher and the media / John Burklow. An introduction to biostatistics : randomization, hypothesis testing, and sample size estimation / Laura Lee Johnson, Craig B. Borkowf, and Paul S. Albert --
Design and conduct of observational studies and clinical trials / Jack M. Guralnik and Teri A. Manolio --
Small clinical trials / Mitchell B. Max --
Large clinical trials and registries : clinical research institutes / Robert M. Califf --
Using secondary data in statistical analysis / Bradley D. Freeman, Steven Banks, and Charles Natanson --
An introduction to survival analysis / Laura Lee Johnson and Joanna H. Shih --
Measures of function and health-related quality of life / Lynn H. Gerber. Overview of technology development / Bruce Goldstein --
Technology transfer / Jack Spiegel --
Writing a protocol / Robert B. Nussenblatt --
Evaluating a protocol budget / Margaret A. Matula --
Data management in clinical research : general principles and a guide to sources / Stephen J. Rosenfeld --
Getting the funding you need to support your research : navigating the national institutes of health peer review process / Olivia T. Bartlett and Elliot Postow --
Clinical research from the industry perspective / Denise T. Resnik --
Human genome project, genomics, and clinical research / Helen N. Lyon and Bruce R. Korf.
|Responsibility:||[edited by] John I. Gallin, Frederick P. Ognibene.|
- Clinical medicine -- Research.
- Human experimentation in medicine.
- Clinical trials.
- Clinical trials -- Law and legislation -- United States.
- National Institutes of Health (U.S.). -- Clinical Center -- Rules and practice.
- National Institutes of Health (U.S.). -- Clinical Center.
- Clinical trials -- Law and legislation.
- United States.