UID:
almafu_9958075875802883
Umfang:
1 online resource (511 p.)
ISBN:
1-281-03292-1
,
9786611032920
,
0-08-053953-X
Inhalt:
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigator
Anmerkung:
Description based upon print version of record.
,
Front Cover; Principles and Practice of Clinical Research; Copyright Page; Contents; Contributors; Preface; Acknowledgments; Chapter 1. A Historical Perspective on Clinical Research; The Earliest Clinical Research; The Greek and Roman Influence; Middle Ages and Renaissance; Seventeenth Century; Eighteenth Century; Nineteenth Century; Twentieth Century and Beyond; PART I: ETHICAL, REGULATORY, AND LEGAL ISSUES; Chapter 2. Ethical Principles in Clinical Research; Distinguishing Clinical Research from Clinical Practice; What Does Ethics Have to Do with Clinical Research?
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History of Ethical Attention to Clinical ResearchEthical Principles and Guidelines for the Protection of Human Subjects of Research: the Belmont Principles; Special Issues in the Conduct of Randomized Clinical Trials; Summary; Chapter 3. Researching a Bioethical Question; Types of Bioethical Issues; Types of Bioethical Research Methodologies; Examples of Important Bioethical Research; Special Considerations in Bioethical Research; Chapter 4. Integrity in Research: Individual and Institutional Responsibility; Recent History of the Scientific Misconduct Issue; Responses of Government
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Responses of the Scientific CommunityGuidelines for the Conduct of Research; Definition of Scientific Misconduct; Authorship; Conflicts of Interest; Conclusions; Chapter 5. Institutional Review Boards; Historical, Ethical, and Regulatory Foundations for Current Requirements for Research Involving Human Subjects; Institutional Review Boards; Clinical Researchers and IRBs; The Current IRB System Under Evaluation; Conclusion; Chapter 6. Data and Safety Monitoring Boards; Description of Data and Safety Monitoring Board; Data and Safety Monitoring Board Functions
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Data and Safety Monitoring Board Decision MakingExamples; Conclusions; Chapter 7. Data and Data Management Clinical Trials; Definitions; Roles and Responsibilities; Administrative Aspects; Research Records; Data Standardization Coding Systems; Quality Assurance; Audits; Audit Preparation; Data Analysis; Security; Archiving; Summary; Conclusion; Chapter 8. Unanticipated Risk in Clinical Research; The Reasons; The Drug; The Target; The Trials; Cassandra Revealed; Extended Studies; FIAU Toxicity; Reassessing the Preclinical Studies; Research Oversight; The Investigations Begin
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Scientific MisconductThe FDA; The NIH; The Institute of Medicine; The Media; The Congress; The Law; Epilogue; Chapter 9. The Regulation of Drugs and Biological Products by the Food and Drug Administration; Background; Mission, Organization, and Terminology; Drug and Biologic Life Cycle; Summary; Appendix; Chapter 10. Legal Issues; Legal Issues Related to Informed Consent for Clinical and Research Care; Advance Directives/Substitute Consent; Children in Research; Medical/Research Records; Legal Liability; Conflict of Interest; Authorship/Rights in Data
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Appendix: NIH Advance Directive for Health Care and Medical Research Participation
,
English
Weitere Ausg.:
ISBN 0-12-274065-3
Sprache:
Englisch
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