Journal article
CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes
Clinical and translational science, Vol.8(6), pp.623-631
12/2015
DOI: 10.1111/cts.12306
PMCID: PMC4703465
PMID: 26184433
Abstract
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.
Details
- Title: Subtitle
- CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes
- Creators
- Harry P Selker - Tufts Medical CenterJohn B Buse - University of North Carolina at Chapel HillRobert M Califf - Duke UniversityRobert Carter - National Institutes of HealthDan M Cooper - University of California, IrvineJonathan Davis - Tufts Medical CenterDaniel E Ford - Johns Hopkins UniversityPietro Galassetti - University of California, IrvineLisa Guay-Woodford - Clinical and Translational Science Institute at Children's National Washington DC USAGordon S Huggins - Tufts Medical CenterAmanda Kasper - Clinical and Translational Science Institute at Children's National Washington DC USAKarl Kieburtz - University of Rochester Medical CenterAaron Kirby - Tufts Medical CenterAndreas K Klein - Tufts Medical CenterJoel Kline - University of IowaRobert T O' Neill - United States Food and Drug AdministrationMarie Rape - University of North Carolina at Chapel HillDouglas J Reichgott - Tufts Medical CenterSvetlana Rojevsky - Tufts Medical CenterGary E Rosenthal - University of IowaEric P Rubinstein - University of Rochester Medical CenterAmy Shepherd - Tufts Medical CenterMark Stacy - Duke UniversityNorma Terrin - Tufts Medical CenterMark Wallace - University of California San DiegoLisa Welch - Tufts Medical Center
- Resource Type
- Journal article
- Publication Details
- Clinical and translational science, Vol.8(6), pp.623-631
- DOI
- 10.1111/cts.12306
- PMID
- 26184433
- PMCID
- PMC4703465
- NLM abbreviation
- Clin Transl Sci
- ISSN
- 1752-8054
- eISSN
- 1752-8062
- Grant note
- 1UL1TR001111 / NCATS NIH HHS UL1TR001117 / NCATS NIH HHS UL1TR001079 / NCATS NIH HHS UL1TR000075 / NCATS NIH HHS UL1 TR001414 / NCATS NIH HHS UL1TR000042 / NCATS NIH HHS UL1TR000100 / NCATS NIH HHS UL1TR000153 / NCATS NIH HHS UL1 TR001079 / NCATS NIH HHS UL1 TR001064 / NCATS NIH HHS U54TR001013 / NCATS NIH HHS
- Language
- English
- Date published
- 12/2015
- Academic Unit
- Pulmonary, Critical Care, and Occupational Medicine; Occupational and Environmental Health; Internal Medicine
- Record Identifier
- 9984359861902771
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