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| Clinical Research and the Law, 1e |
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※해외주문 도서 안내 :
- 해외 및 국내 입고 사항에 따라 2~8주 이상 소요될 수 있으며. 취소 및 반품이 불가능합니다.
- 해외주문도서는 해외 출판사 사정에 의해 품절/지연될수 있습니다. |
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※교환 및 반품안내 :
- 교환이나 반품시 상품 수령후 3일이내 교환이나 반품 의사를 알려주시고 일주일이내에 저희쪽으로 상품이 입고되어야합니다.
시일이 경과되면 반품이 불가합니다.
- 변심에 의한 교환이나 반품시, 배송비는 고객님께서 부담하시며, 오배송이나 상품 불량시에는 무료 교환이 가능합니다.
- 반품시에는 반품상품 검수후 카드 취소를 해드리거나 통장,적립금등으로 환불 조치 해 드립니다. |
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※배송안내 :
- 제주도및 도서산간지역은 택배비가 추가될수 있습니다. |
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The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues. Including:
•standards and duty of care
•informed consent
•conflicts of interest
•research contracts
•establishing clinical trials
•the disclosure and withholding of clinical trial results
Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards.
This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
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Preface
Chapter One: Research Malpractice & Negligence
Chapter Two: Duty of Care: Understanding the Legal
Differences Between Medical Treatment and Medical Research
Chapter Three: Establishing Standard of Care & Violation of Standard of Care
Chapter Four: Informed Consent in Clinical Research
Chapter Five: Liability Issues for Institutional Review
Boards (IRB’s) and Data Safety Monitoring Boards (DSMB’s)
Chapter Six: Legal Aspects of Financial Conflicts of Interest in Clinical Trials
Chapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study Results
Chapter Eight: Clinical Trials & Insider Trading
Chapter Nine: Clinical Trials and Criminal Law
Chapter Ten: Clinical Trial Contracts
Appendix A Glossary
Appendix B NIH Policy on Inclusion of Children as Participants in Research Involving Human Subjects
Appendix C Best Pharmaceuticals for Children Act p>Appendix D Pediatric Research Equity Act 2003
Appendix E Code of Federal Regulations Title 21
Appendix F NCI model contract
Appendix G Conflicts of Interest
Index |
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등록된 서평이 없습니다. |
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과별도서목록
