Research regulatory compliance / / editors, Mark A. Suckow, Bill J. Yates

• Pubblicazione: London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015; ©2015
• Descrizione fisica: 1 online resource (345 p.)
• Disciplina: 338.97306
• Soggetto topico: Research - Government policy - United States; Research - Moral and ethical aspects; Medicine - Research - Moral and ethical aspects
• Soggetto geografico: United States
• Persona (resp. second.): SuckowMark A.; YatesBill
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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 ; 1. SUMMARY
• Sommario/riassunto: 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
• Titolo autorizzato: Research regulatory compliance
• ISBN: 0-12-420065-6
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910797243603321
• Lo trovi qui: Univ. Federico II