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CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes.
Selker, Harry P; Buse, John B; Califf, Robert M; Carter, Robert; Cooper, Dan M; Davis, Jonathan; Ford, Daniel E; Galassetti, Pietro; Guay-Woodford, Lisa; Huggins, Gordon S; Kasper, Amanda; Kieburtz, Karl; Kirby, Aaron; Klein, Andreas K; Kline, Joel; O' Neill, Robert T; Rape, Marie; Reichgott, Douglas J; Rojevsky, Svetlana; Rosenthal, Gary E; Rubinstein, Eric P; Shepherd, Amy; Stacy, Mark; Terrin, Norma; Wallace, Mark; Welch, Lisa.
Afiliación
  • Selker HP; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Buse JB; University of North Carolina at Chapel Hill, Translational & Clinical Sciences Institute, Chapel Hill, North Carolina, USA.
  • Califf RM; Duke Translational Medicine Institute, Duke University, Durham, North Carolina, USA.
  • Carter R; National Institutes of Health, Bethesda, Maryland, USA.
  • Cooper DM; Institute for Clinical and Translational Science, University of California, Irvine, California, USA.
  • Davis J; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Ford DE; Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland, USA.
  • Galassetti P; Institute for Clinical and Translational Science, University of California, Irvine, California, USA.
  • Guay-Woodford L; Clinical and Translational Science Institute at Children's National, Washington, DC, USA.
  • Huggins GS; Tufts Medical Center, Boston, Massachusetts, USA.
  • Kasper A; Clinical and Translational Science Institute at Children's National, Washington, DC, USA.
  • Kieburtz K; Clinical and Translational Science Institute, University of Rochester Medical Center, University of Rochester, Rochester, New York, USA.
  • Kirby A; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Klein AK; Tufts Medical Center, Boston, Massachusetts, USA.
  • Kline J; Institute for Clinical and Translational Science at the University of Iowa, University of Iowa, Iowa City, Iowa, USA.
  • O' Neill RT; U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Rape M; University of North Carolina at Chapel Hill, Translational & Clinical Sciences Institute, Chapel Hill, North Carolina, USA.
  • Reichgott DJ; Tufts Medical Center, Boston, Massachusetts, USA.
  • Rojevsky S; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Rosenthal GE; Institute for Clinical and Translational Science at the University of Iowa, University of Iowa, Iowa City, Iowa, USA.
  • Rubinstein EP; Clinical and Translational Science Institute, University of Rochester Medical Center, University of Rochester, Rochester, New York, USA.
  • Shepherd A; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Stacy M; Duke Translational Medicine Institute, Duke University, Durham, North Carolina, USA.
  • Terrin N; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
  • Wallace M; Clinical and Translational Research Institute, University of California, San Diego, USA.
  • Welch L; Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
Clin Transl Sci ; 8(6): 623-31, 2015 Dec.
Article en En | MEDLINE | ID: mdl-26184433
Human research projects must have a scientifically valid study design, analytic plan, and be operationally feasible in order to be successfully completed and thus to have translational impact. To ensure this, institutions that conduct clinical research should have a scientific review process prior to submission to the Institutional Review Committee (IRB). This paper reports the Clinical and Translational Science Award (CTSA) Consortium Scientific Review Committee (SRC) Consensus Working Group's proposed framework for a SRC process. Recommendations are provided for institutional support and roles of CTSAs, multisite research, criteria for selection of protocols that should be reviewed, roles of committee members, application process, and committee process. Additionally, to support the SCR process effectively, and to ensure efficiency, the Working Group recommends information technology infrastructures and evaluation metrics to determine outcomes are provided.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Comités de Ética en Investigación / Investigación Biomédica Traslacional Tipo de estudio: Evaluation_studies / Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Transl Sci Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Comités de Ética en Investigación / Investigación Biomédica Traslacional Tipo de estudio: Evaluation_studies / Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Transl Sci Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos