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

Autor: Mark Stacy, Andreas K. Klein, Aaron Kirby, Marie Rape, Dan M. Cooper, Svetlana Rojevsky, Amy Shepherd, Daniel E. Ford, Robert M. Califf, Joel N. Kline, Norma Terrin, Douglas J. Reichgott, Harry P. Selker, Jonathan M. Davis, Gary E. Rosenthal, Mark S. Wallace, Eric P. Rubinstein, Robert H. Carter, Robert T. O’ Neill, Lisa Guay-Woodford, John B. Buse, Gordon S. Huggins, Amanda Kasper, Pietro Galassetti, Lisa C. Welch, Karl Kieburtz
Jazyk: angličtina
Rok vydání: 2015
Předmět:
medicine.medical_specialty
Biomedical Research
Consensus
Process (engineering)
Oncology and Carcinogenesis
Advisory Committees
Awards and Prizes
CTSA Profile
Translational research
Cardiorespiratory Medicine and Haematology
0603 philosophy
ethics and religion
Institutional support
General Biochemistry
Genetics and Molecular Biology
Organizational
Translational Research
Biomedical
outcomes research
03 medical and health sciences
0302 clinical medicine
Models
medicine
Humans
030212 general & internal medicine
General Pharmacology
Toxicology and Pharmaceutics
Translational Medical Research
General Clinical Medicine
Ethics Committees
clinical trials
Other Medical and Health Sciences
Informed Consent
business.industry
Research
General Neuroscience
NEWS AND VIEWS
Information technology
06 humanities and the arts
General Medicine
United States
Clinical trial
Engineering management
translational research
Models
Organizational
Clinical and Translational Science Award
060301 applied ethics
Human research
Outcomes research
business
Ethics Committees
Research
Program Evaluation
Zdroj: Selker, HP; Buse, JB; Califf, RM; Carter, R; Cooper, DM; Davis, J; et al.(2015). CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes. Clinical and Translational Science, 8(6), 623-631. doi: 10.1111/cts.12306. UC Irvine: Retrieved from: http://www.escholarship.org/uc/item/6pz86134
Clinical and Translational Science
Selker, HP; Buse, JB; Califf, RM; Carter, R; Cooper, DM; Davis, J; et al.(2015). CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes. Clinical and Translational Science. doi: 10.1111/cts.12306. UC Irvine: Retrieved from: http://www.escholarship.org/uc/item/7vt4486v
Clinical and Translational Science, vol 8, iss 6
Clinical and translational science, vol 8, iss 6
DOI: 10.17615/dsq3-hx24
Popis: © 2015 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. 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.
Databáze: OpenAIRE
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