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. Rosenthal; Eric P. Rubinstein; Amy Shepherd; Mark Stacy; Norma Terrin; Mark Wallace; Lisa Welch

doi:10.1111/cts.12306

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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 language	English (US)
Pages (from-to)	623-631
Number of pages	9
Journal	Clinical and translational science
Volume	8
Issue number	6
DOIs	https://doi.org/10.1111/cts.12306
State	Published - Dec 1 2015

Keywords

Clinical trials
Outcomes research
Translational research

ASJC Scopus subject areas

General Pharmacology, Toxicology and Pharmaceutics
General Biochemistry, Genetics and Molecular Biology
General Neuroscience

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10.1111/cts.12306

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Selker, H. P., Buse, J. B., Califf, R. M., Carter, R., Cooper, D. M., Davis, J., Ford, D. E., Galassetti, P., Guay-Woodford, L., Huggins, G. S., Kasper, A., Kieburtz, K., Kirby, A., Klein, A. K., Kline, J., O' Neill, R. T., Rape, M., Reichgott, D. J., Rojevsky, S., ... Welch, L. (2015). CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes. Clinical and translational science, 8(6), 623-631. https://doi.org/10.1111/cts.12306

Selker, HP, Buse, JB, Califf, RM, Carter, R, Cooper, DM, Davis, J, Ford, DE, Galassetti, P, Guay-Woodford, L, Huggins, GS, Kasper, A, Kieburtz, K, Kirby, A, Klein, AK, Kline, J, O' Neill, RT, Rape, M, Reichgott, DJ, Rojevsky, S, Rosenthal, GE, Rubinstein, EP, Shepherd, A, Stacy, M, Terrin, N, Wallace, M & Welch, L 2015, 'CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes', Clinical and translational science, vol. 8, no. 6, pp. 623-631. https://doi.org/10.1111/cts.12306

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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.",

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AU - O' Neill, Robert T.

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AU - Reichgott, Douglas J.

AU - Rojevsky, Svetlana

AU - Rosenthal, Gary E.

AU - Rubinstein, Eric P.

AU - Shepherd, Amy

AU - Stacy, Mark

AU - Terrin, Norma

AU - Wallace, Mark

AU - Welch, Lisa

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

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Keywords

ASJC Scopus subject areas

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