title: CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes.
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.
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Harry P
authors.initials: HP
authors.lastname: Selker
authors.affiliation: University of North Carolina at Chapel Hill, Translational & Clinical Sciences Institute, Chapel Hill, North Carolina, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Buse
authors.affiliation: Duke Translational Medicine Institute, Duke University, Durham, North Carolina, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.affiliation: National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Carter
authors.affiliation: Institute for Clinical and Translational Science, University of California, Irvine, California, USA.
authors.forename: Dan M
authors.initials: DM
authors.lastname: Cooper
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Davis
authors.affiliation: Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Ford
authors.affiliation: Institute for Clinical and Translational Science, University of California, Irvine, California, USA.
authors.forename: Pietro
authors.initials: P
authors.lastname: Galassetti
authors.affiliation: Clinical and Translational Science Institute at Children's National, Washington, DC, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Guay-Woodford
authors.affiliation: Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Gordon S
authors.initials: GS
authors.lastname: Huggins
authors.affiliation: Clinical and Translational Science Institute at Children's National, Washington, DC, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Kasper
authors.affiliation: Clinical and Translational Science Institute, University of Rochester Medical Center, University of Rochester, Rochester, New York, USA.
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Kirby
authors.affiliation: Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Andreas K
authors.initials: AK
authors.lastname: Klein
authors.affiliation: Institute for Clinical and Translational Science at the University of Iowa, University of Iowa, Iowa City, Iowa, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Kline
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Robert T
authors.initials: RT
authors.lastname: O' Neill
authors.affiliation: University of North Carolina at Chapel Hill, Translational & Clinical Sciences Institute, Chapel Hill, North Carolina, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Rape
authors.affiliation: Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Reichgott
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Rojevsky
authors.affiliation: Institute for Clinical and Translational Science at the University of Iowa, University of Iowa, Iowa City, Iowa, USA.
authors.forename: Gary E
authors.initials: GE
authors.lastname: Rosenthal
authors.affiliation: Clinical and Translational Science Institute, University of Rochester Medical Center, University of Rochester, Rochester, New York, USA.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Rubinstein
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Shepherd
authors.affiliation: Duke Translational Medicine Institute, Duke University, Durham, North Carolina, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Stacy
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Norma
authors.initials: N
authors.lastname: Terrin
authors.affiliation: Clinical and Translational Research Institute, University of California, San Diego, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Wallace
authors.affiliation: Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Welch
mesh_terms: D026683:Advisory Committees; D001363:Awards and Prizes; D035843:Biomedical Research; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D017146:Models, Organizational; D015397:Program Evaluation; D057170:Translational Research, Biomedical / Q000639:trends*; D014481:United States
keywords: clinical trials; outcomes research; translational research