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Principles and Practice of Clinical Research.

Author: John I Gallin
Publisher: Amsterdam ; Boston : Elsevier Science & Technology, 2007.
Edition/Format:   eBook : Document : English : 2nd edView all editions and formats
Database:WorldCat
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Genre/Form: Electronic books
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: John I Gallin
OCLC Number: 441807935
Description: 1 online resource (xvi, 430 p.) : ill.
Contents: Cover --
Copyright page --
Table of contents --
Preface --
Acknowledgements --
Contributors --
Chapter 1: A Historical Perspective on Clinical Research --
1. THE EARLIEST CLINICAL RESEARCH --
2. THE GREEK AND ROMAN INFLUENCE --
3. MIDDLE AGES AND RENAISSANCE --
4. SEVENTEENTH CENTURY --
5. EIGHTEENTH CENTURY --
6. NINETEENTH CENTURY --
7. TWENTIETH CENTURY AND BEYOND --
Acknowledgment --
References and Notes --
PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES --
Chapter 2: Ethical Principles in Clinical Research --
1. DISTINGUISHING CLINICAL RESEARCH FROM CLINICAL PRACTICE --
2. WHAT DOES ETHICS HAVE TO DO WITH CLINICAL RESEARCH? --
3. HISTORY OF ETHICAL ATTENTION TO CLINICAL RESEARCH --
4. CODES OF RESEARCH ETHICS AND REGULATIONS --
5. ETHICAL FRAMEWORK FOR CLINICAL RESEARCH --
6. ETHICAL CONSIDERATIONS IN RANDOMIZED CLINICAL TRIALS --
7. CONCLUSION --
References --
Chapter 3: Researching a Bioethical Question --
1. TYPES OF BIOETHICAL ISSUES --
2. TYPES OF BIOETHICAL RESEARCH METHODOLOGIES --
3. EXAMPLES OF IMPORTANT BIOETHICAL RESEARCH --
4. SPECIAL CONSIDERATIONS IN BIOETHICAL RESEARCH --
References and Notes --
Chapter 4: Integrity in Research: Individual and Institutional Responsibility --
1. GUIDELINES FOR THE CONDUCT OF RESEARCH --
2. SCIENTIFIC INTEGRITY AND MISCONDUCT --
3. MENTOR-TRAINEE RELATIONSHIPS --
4. DATA ACQUISITION, MANAGEMENT, SHARING, AND OWNERSHIP --
5. RESEARCH INVOLVING HUMAN AND ANIMAL SUBJECTS --
6. COLLABORATIVE SCIENCE --
7. CONFLICT OF INTEREST AND COMMITMENT --
8. PEER REVIEW --
9. PUBLICATION PRACTICES AND RESPONSIBLE AUTHORSHIP --
Acknowledgment --
References --
Chapter 5: Institutional Review Boards --
1. HISTORICAL, ETHICAL, AND REGULATORY FOUNDATIONS OF CURRENT REQUIREMENTS FOR RESEARCH INVOLVING HUMAN SUBJECTS --
2. INSTITUTIONAL REVIEW BOARDS --
3. CLINICAL RESEARCHERS AND IRBs --
4. THE CURRENT IRB SYSTEM UNDER EVALUATION --
5. CONCLUSION --
References and Notes --
Chapter 6: Data and Safety Monitoring Boards --
1. DESCRIPTION OF THE DATA AND SAFETY MONITORING BOARD --
2. DATA AND SAFETY MONITORING BOARD FUNCTIONS --
3. DATA AND SAFETY MONITORING BOARD DECISION MAKING --
4. EXAMPLES --
5. CONCLUSIONS --
References --
Chapter 7: Data Management in Clinical Trials --
1. THE RESEARCH TEAM --
2. PLANNING THE TRIAL --
3. WHERE ARE DATA? --
4. WHO CAN COLLECT DATA? --
5. SITE INITIATION VISIT --
6. INFORMED CONSENT --
7. ELIGIBILITY --
8. REGISTRATION --
9. WHAT DATA DO YOU COLLECT? --
10. TREATMENT PLAN --
11. CONCURRENT THERAPY --
12. ADVERSE EVENT MONITORING --
13. ROUTINE MONITORING VISITS --
14. AUDIT TRAIL --
15. ELECTRONIC DATABASE --
16. SUMMARY --
References --
Chapter 8: Unanticipated Risk in Clinical Research --
1. THE REASONS --
2. THE DRUG --
3. THE TARGET --
4. THE TRIALS --
5. CASSANDRA REVEALED --
6. EXTENDED STUDIES --
7. FIAU TOXICITY --
8. REASSESSING THE PRECLINICAL STUDIES --
9. RESEARCH OVERSIGHT --T$10.

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