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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 临床研究 » Clinical research and the law
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[资源] Clinical research and the law

Clinical research and the law
Clinical Research and the Law

Chapter 1: Research malpractice and negligence, 1
Chapter 2: Duty of care: understanding the legal differences
Chapter 3: Establishing standard of care and violation of
Chapter 4: Informed consent in clinical research, 37
Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs), 55
Chapter 6: Legal aspects of financial conflicts of interest in
Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results, 87
Chapter 8: Clinical trials and insider trading, 105
Chapter 9: Clinical trials and criminal law, 117
Chapter 10: Clinical trial contracts, 145
Appendix A: Glossary of common terms used in connection with clinical trials, 151
Appendix B: Research involving human subjects, 163
Appendix C: Best pharmaceuticals for Children Act, 173
Appendix D: Pediatric research Equity Act of 2003, 193
Appendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations, 203
Appendix F: Proposed standardized/harmonized clauses for clinical trial agreements, 209
Appendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, 225

[ Last edited by 1949stone on 2013-12-18 at 09:52 ]
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