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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, thi...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Suckow, Mark A. (Editor ), Yates, Bill J. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London : Academic Press is an imprint of Elsevier, [2015]
Temas:
Research > Government policy > United States.
Research > Moral and ethical aspects.
Medicine > Research > Moral and ethical aspects.
Laboratories > Management.
Research > standards
Research > legislation & jurisprudence
Recherche > Politique gouvernementale > États-Unis.
Recherche > Aspect moral.
Médecine > Recherche > Aspect moral.
SCIENCE > Research & Methodology.
Laboratories > Management
Medicine > Research > Moral and ethical aspects
Research > Government policy
Research > Moral and ethical aspects
United States
Internet Resources.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; RESEARCH REGULATORY COMPLIANCE; Copyright; Contents; Contributors; Preface; 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 MANDATES6. 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; 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 PERSPECTIVES3. 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 CHALLENGES7. 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; 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 DOCUMENTS6. 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

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