Creation of an institutional semi-independent data monitoring committee.
Background: A major goal of the National Institutes of Health's Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services...
| Publicado en: | Clinical Trials Vol. 16; no. 5; pp. 523 - 531 |
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| Autores principales: | , , |
| Formato: | forms glossary tables/charts Journal Article |
| Publicado: |
Sage Publications, Ltd.
Oct2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| Sumario: | Background: A major goal of the National Institutes of Health's Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services to facilitate the conduct of clinical research, including support with fulfilling regulatory requirements. Methods: The University of Kentucky sought to establish an institutional semi-independent monitoring committee to provide oversight for clinical research studies per National Institutes of Health requirements and recommendations. Our semi-independent monitoring committee was initiated in 2010. Results: Since the inception of our semi-independent monitoring committee we have restructured its operations and protocols to improve efficiency. This article discusses our experiences with semi-independent monitoring committee creation and growth. Conclusion: This article summarizes our experience in creating and maturing an institutional data monitoring committee. |
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