1.

Record Nr.

UNINA9910452082503321

Titolo

Developing 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 Academies

Pubbl/distr/stampa

Washington, D.C., : National Academies Press, c2006

ISBN

1-280-50667-9

9786610506675

0-309-65577-3

Descrizione fisica

1 online resource (124 p.)

Disciplina

615.5072

Soggetti

Clinical trials - United States

Clinical medicine - Research

Electronic books.

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. 47-48).

Nota di contenuto

""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 ""