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|Additional Physical Format:||Print version:
Principles and practice of clinical research.
Amsterdam : Elsevier/AP, 2012
|Material Type:||Document, Internet resource|
|Document Type:||Internet Resource, Computer File|
|All Authors / Contributors:||
John I Gallin; Frederick P Ognibene
|ISBN:||9780123821676 0123821673 9780123821683 0123821681 9781283735186 1283735180|
|Description:||1 online resource (xv, 780 pages) : illustrations|
|Contents:||A historical perspective on clinical research --
Ethical principles in clinical research --
Researching a bioethical question --
Integrity in research : Individual and institutional responsibility --
Institutional review boards --
The role of independent institutional review boards --
The regulation of drugs and biological products by the Food and Drug Administration --
Data management in clinical trials --
Data and safety monitoring --
Unanticipated risk in clinical research --
Legal issues --
Rules to prevent conflict of interest for clinical investigators conducting human subjects research --
National Institutes of Health Policy on the inclusion of women and minorities as subjects in clinical research --
Accreditation of human research protection programs --
The role and importance of clinical trial registries and results databases --
The clinical researcher and the media --
Clinical research : A patient perspective --
Design of observational studies --
Design of clinical studies and trials --
Issues in randomization --
Hypothesis testing --
Power and sample size calculations --
An introduction to survival analysis --
Intermediate topics in biostatistics --
Measures of function and health-related quality of life --
Large clinical trials and registries--Clinical Research Institutes --
Meta-analysis of clinical trials --
Using large datasets for population-based health research --
Development and conduct of studies --
Overview of technology development --
Patents and patent licenses --
Writing a protocol --
Evaluating a protocol budget --
Clinical research data : Characteristics, representation, storage, and retrieval --
Management of patient samples and specimens --
Getting the funding you need to support your research : Navigating the National Institutes of Health peer review process --
Clinical research from the Industry perspective --
Philanthropic sector support for medical research and training : History and trends --
Managing clinical risk and measuring participants' perceptions of the clinical research process --
Integration of specialized research services into clinical laboratory operations --
Imaging in clinical trials --
Role of blood bank and transfusion medicine in clinical research --
Clinical pharmacology and its role in pharmaceutical development --
Career paths in clinical research --
Clinical research nursing : A new domain of practice --
Clinical research applications of health disparities science in community settings --
Issues and challenges for clinical research in international settings--
The power of an undiagnosed diseases program in a clinical research enterprise --
Human genome project, genomics, and clinical research --
Harnessing information using genomic platforms.
|Responsibility:||edited by John I. Gallin, Frederick P. Ognibene.|
PRAISE FOR THE FIRST EDITION: "...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional
- Clinical medicine -- Research.
- Clinical medicine -- Research -- Methodology.
- Biomedical Research -- methods.
- research methods.
- biomedical research.
- HEALTH & FITNESS -- Diseases -- General.
- MEDICAL -- Clinical Medicine.
- MEDICAL -- Diseases.
- MEDICAL -- Evidence-Based Medicine.
- MEDICAL -- Internal Medicine.