CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes

Harry P. Selker, John B. Buse, Robert M. Califf, Robert Carter, Dan M. Cooper, Jonathan Davis, Daniel E. Ford, Pietro Galassetti, Lisa Guay-Woodford, Gordon S. Huggins, Amanda Kasper, Karl Kieburtz, Aaron Kirby, Andreas K. Klein, Joel Kline, Robert T. O' Neill, Marie Rape, Douglas J. Reichgott, Svetlana Rojevsky, Gary E. RosenthalEric P. Rubinstein, Amy Shepherd, Mark Stacy, Norma Terrin, Mark Wallace, Lisa Welch

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)623-631
Number of pages9
JournalClinical and translational science
Volume8
Issue number6
DOIs
StatePublished - Dec 1 2015

Keywords

  • Clinical trials
  • Outcomes research
  • Translational research

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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