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Research Regulatory Compliance 1st Edition by Mark Suckow, Bill Yates 0124200583 9780124200586

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Research Regulatory Compliance 1st Edition Mark A. Suckow Digital Instant Download

Author(s): Mark A. Suckow, Bill Yates
ISBN(s): 9780124200586, 0124200583
Edition: 1
File Details: PDF, 2.90 MB
Year: 2015
Language: english
SKU: EB-5138390 Category: Tags: ,

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Product details:

ISBN 10: 0124200583 

ISBN 13: 9780124200586

Author: Mark A. Suckow, Bill Yates

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory.Provides a “one-stop” , go-to resource for the many regulatory and compliance issues that affect laboratory study and research modelsExtremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjectsWritten and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Table of contents:

Chapter 1. Human Subjects Research Protections

  1. Introduction

  2. Historical Perspectives

  3. Key Regulatory Agencies and Mandate

  4. Common Challenges

  5. Current Influences Shaping the Future of Human Research Subject Protection

Chapter 2. Investigational New Drug and Device Exemption Process

  1. Introduction

  2. Historical Perspectives [1]

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

Chapter 3. The Institutional Animal Care and Use Committee

  1. Introduction

  2. Regulatory History

  3. Relevant Regulatory and Oversight Laws, Regulations, and Guidance Documents

  4. Key Regulatory Mandates for the Institutional Animal Care and Use Committee

  5. Key Personnel and Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

  8. Final Comments

Chapter 4. Biological Hazards and Select Agents

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Key Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

Chapter 5. Radiological Hazards and Lasers

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Key Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

  8. Conclusion

Chapter 6. Controlled Substances: Maintaining Institutional Compliance

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Key Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

Chapter 7. Export Controls and US Research Universities

  1. Summary

  2. Key Definitions

  3. Introduction

  4. Historical Perspectives

  5. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  6. Regulatory Mandates

  7. Key Personnel and University Committees

  8. Common Compliance Challenges

  9. Addressing Noncompliance

Chapter 8. Data Management and Research Integrity

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Key Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

Chapter 9. Intellectual Property

  1. Summary

  2. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  3. Common Compliance Challenges

  4. Addressing Noncompliance

Chapter 10. Financial Conflicts of Interest in Research

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents

  4. Key Regulatory Mandates of the 2011 Public Health Service Regulation

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance

  8. End-of-Chapter Notes

Chapter 11. Good Laboratory Practices (GLPs)

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory/Oversight Agencies

  4. Key Regulatory Mandates

  5. Key Personnel

  6. Common Compliance Challenges

  7. Addressing Noncompliance

Chapter 12. Human Embryonic Stem Cell Research Oversight: A Confluence of Voluntary Self-Regulation and Shifting Policy Initiatives

  1. Introduction

  2. Historical Perspectives

  3. Relevant Regulatory Agencies and Oversight Laws, Regulations, and Guidance Documents in Effect Today

  4. Key Regulatory Mandates

  5. Key Personnel and University Committees Designated to Implement Regulatory Mandates

  6. Common Compliance Challenges

  7. Addressing Noncompliance and Anticipating Emerging Compliance Issues

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Tags: Mark Suckow, Bill Yates, Research, Regulatory, Compliance