Cancer Clinical Trials: Proactive Strategies

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Stanley P. L. Leong
Springer Science & Business Media, Nov 25, 2007 - Medical - 320 pages
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Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application.

 

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Contents

Historical Perspective and Evolving Concerns for Human Research
1
Cancer Trials and the Institutional Review Board IRB
11
NCIs Cancer Therapy Evaluation Program A Commitment to Treatment Trials
31
Practical Guide for Cancer Clinical Investigators
51
The Role of Cooperative Groups in Cancer Clinical Trials
111
The Advocate Role in Clinical Study Development and Partnership with Patient Advocates in Your Local Institution
130
The National Breast Cancer Coalition Setting the Standard for Advocate Collaboration in Clinical Trials
143
The Role of the Principal Investigator in Cancer Clinical Trials
157
The Privacy Rule HIPAA As It Relates To Clinical Research
199
The Commission on Cancer American College of Surgeons Response to HIPAA
208
Ethical and Legal Issues in the Conduct of Cancer Clinical Trials
219
The Role of the Office of Research Integrity in Cancer Clinical Trials
230
Strategies for the Administration of a Clinical Trail Infrastructure Lessons from a Comprehensive Cancer Center
241
The Clinical Research Process Building a System in Harmony with Its Users
275
Cancer Research and Clinical Trial in Action An Important Exercise Before You Embark on Your Study
291
Index
310

The Audit Process and How to Ensure a Successful Audit
178

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