Open AccessCTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes
Author(s) -
Selker Harry P.,
Buse John B.,
Califf Robert M.,
Carter Robert,
Cooper Dan M.,
Davis Jonathan,
Ford Daniel E.,
Galassetti Pietro,
GuayWoodford 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
Publication year - 2015
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12306
Subject(s) - process (computing) , translational research , working group , plan (archaeology) , institutional review board , medicine , medical education , process management , computer science , knowledge management , political science , business , pathology , biology , law , paleontology , surgery , operating system
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.