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 |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=138612531&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 138612531 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Oct2019 vid: 16 iid: 5 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 138612531 138612531 138612531 10.1177/1740774519859876 138612531 ppf: 523 ppct: 8 formats: tig: atl: Creation of an institutional semi-independent data monitoring committee. aug: au: Tannock, Lisa R Barton-Baxter, Marietta Stoops, William W affil: Department of Internal Medicine, University of Kentucky, Lexington, KY, USA sug: subj: Clinical Trials Organizations Data Management Professional Organizations Awards and Honors Rules and Regulations Leadership Membership Organizational Development Organizational Efficiency Organizational Objectives ab: 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. pubtype: Academic Journal doctype: forms glossary tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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