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

Detalles Bibliográficos
Autor Corporativo: Institute of Medicine (U.S.). Committee on Clinical Trial Registries (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press c2006.
Edición:1st ed
Materias:
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820317806719
Tabla de Contenidos:
  • ""Front Matter""; ""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 ""