03012nam 2200577Ia 450 991077764100332120230828220704.00-309-18054-61-280-50667-997866105066750-309-65577-3(CKB)1000000000465560(EBL)3378103(SSID)ssj0000137676(PQKBManifestationID)11158795(PQKBTitleCode)TC0000137676(PQKBWorkID)10088602(PQKB)10195975(MiAaPQ)EBC3378103(Au-PeEL)EBL3378103(CaPaEBR)ebr10132071(CaONFJC)MIL50667(OCoLC)923275635(EXLCZ)99100000000046556020060809d2006 uy 0engurcn|||||||||txtccrDeveloping a national registry of pharmacologic and biologic clinical trials[electronic resource] workshop report /Committee on Clinical Trial Registries, Board on Health Sciences Policy, Institute of Medicine of the National AcademiesWashington, D.C. National Academies Pressc20061 online resource (124 p.)Description based upon print version of record.0-309-10078-X Includes bibliographical references (p. 47-48).""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 ""Clinical trialsUnited StatesClinical medicineResearchClinical trialsClinical medicineResearch.615.5072Institute of Medicine (U.S.).Committee on Clinical Trial Registries.MiAaPQMiAaPQMiAaPQBOOK9910777641003321Developing a national registry of pharmacologic and biologic clinical trials3830700UNINA