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PAPERBACK list:$31.75 Web:$28.57 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Preventing Medication Errors: Quality Chasm Series Other Related Titles Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report (2006) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 95   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. F Illustrative Data Fields for the Results Summary (based on ICH E3 template*) Page 95 Front Matter (R1-R20) 1 Summary (1-4) 2 The Need for Clinical Trial Registries (5-8) 3 Current Registry Activities (9-18) 4 Content of a Clinical Trial Registry (19-34) 5 Implementation Issues (35-42) 6 Conclusion and Next Steps (43-46) References (47-48) Appendix A Participants and Invited Experts - Between December 1, 2004 and June 27, 2005 (49-50) Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005 (51-62) Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials... (63-80) Appendix D Published Journal Editorials (81-90) Appendix E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (91-94) Appendix F Illustrative Data Fields for the Results Summary (95-96) Appendix G Biographical Sketches of Committee Members (97-104)

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary F Illustrative Data Fields for the Results Summary (based on ICH E3 template*)

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary *   Based on the ICH E3 template in the Food and Drug Administration (FDA) report, Guideline for Industry Structure and Content of Clinical Study Reports, July 1996.

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