Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections /

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A must-have guide for any professional in the drug manufacturing industry. The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Mihajlovic-Madzarevic, Vera
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2010.
Temas:
Drugs > Testing > Auditing.
Medical audit.
Quality control.
Clinical Trials as Topic > standards
Guideline Adherence > standards
Management Audit
Quality Control
Medical Audit
Soins médicaux > Évaluation.
Gestion > Contrôle.
Qualité > Contrôle.
quality control.
MEDICAL > Chemotherapy.
Quality control
Medical audit
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Good clinical practice and therapeutic product development
  • Therapeutic products clinical development in the United States
  • The inspection preparation
  • Analysis of warning letters
  • Fraud and misconduct in clinical research
  • Appendix A: some answers to the most problematic questions in compliance
  • Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance
  • Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects
  • Appendix D: Nuremberg Code
  • Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research.

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