Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations.

Tantsyura, Vadim; Dunn, Imogene McCanless; Waters, Joel; Fendt, Kaye; Kim, Yong Joong; Viola, Deborah; Mitchel, Jules

Tantsyura, Vadim; Dunn, Imogene McCanless; Waters, Joel; Fendt, Kaye; Kim, Yong Joong; Viola, Deborah; Mitchel, Jules.

Afiliação

Tantsyura V; 1 Target Health Inc, New York, NY, USA.
Dunn IM; 2 vTv Therapeutics LLC, High Point, NC, USA.
Waters J; 3 PAREXEL International, Durham, NC, USA.
Fendt K; 4 Duke Clinical Research Institute, Durham, NC, USA.
Kim YJ; 1 Target Health Inc, New York, NY, USA.
Viola D; 5 Center for Regional Healthcare Innovation, Westchester Medical Center, Hawthorne, NY, USA.
Mitchel J; 1 Target Health Inc, New York, NY, USA.

Ther Innov Regul Sci ; 50(1): 115-122, 2016 Jan.

Article em En | MEDLINE | ID: mdl-30236023

Palavras-chave

RBM; SDV; clinical trials; data quality; risk-based monitoring; site monitoring; source document verification

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Guideline / Health_economic_evaluation / Risk_factors_studies Idioma: En Ano de publicação: 2016 Tipo de documento: Article

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