Developing a national registry of pharmacologic and biologic clinical trials : workshop report /

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Committee on Clinical Trial Registries
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, ©2006.
Temas:
Clinical trials > United States.
Clinical medicine > Research.
Clinical Trials
Research Design
Registries
Études cliniques > États-Unis.
Médecine clinique > Recherche.
HEALTH & FITNESS > Alternative Therapies.
MEDICAL > Healing.
HEALTH & FITNESS > Healing.
BODY, MIND & SPIRIT > Healing > General.
Clinical trials.
United States
United States.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • FrontMatter
  • Independent Report Reviewers
  • Foreword
  • Preface
  • Contents
  • List of Tables
  • 1 Summary
  • 2 The Need for Clinical Trial Registries
  • 3 Current Registry Activities
  • 4 Content of a Clinical Trial Registry
  • 5 Implementation Issues
  • 6 Conclusion and Next Steps
  • References
  • APPENDIXES
  • A Participants and Invited Experts Between December 1, 2004, and June 27, 2005
  • B Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005
  • C Section 113 of the Food and Drug Administration Modernization Act of 1997 and Guidance for Industry: Information Programs on Clinical Trials for Serious or Life- Threatening Diseases and Conditions. U.S. Department of Health and Human Services. D Published Journal Editorials
  • E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases
  • F Illustrative Data Fields for the Results Summary (based on ICH E3 template)
  • G Biographical Sketches of Committee Members

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