Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials.

Sheetz, Nicole; Wilson, Brett; Benedict, Joanne; Huffman, Esther; Lawton, Andy; Travers, Mark; Nadolny, Patrick; Young, Stephen; Given, Kyle; Florin, Lawrence

Sheetz, Nicole; Wilson, Brett; Benedict, Joanne; Huffman, Esther; Lawton, Andy; Travers, Mark; Nadolny, Patrick; Young, Stephen; Given, Kyle; Florin, Lawrence.

Afiliação

Sheetz N; 1 Clinical Development Innovation, Eli Lilly and Company, Indianapolis, IN, USA.
Wilson B; 2 Global Development Operations, Bristol-Myers Squibb, Princeton, NJ, USA.
Benedict J; 3 Global Product Development, Roche, Genentech, San Francisco, CA, USA.
Huffman E; 4 Global Development Operations, Bristol-Myers Squibb, Princeton, NJ, USA.
Lawton A; 5 Biometrics and Data Management, Boehringer Ingelheim, Bracknell, UK.
Travers M; 6 Clinical Sciences and Operations, Sanofi, Bridgewater, NJ, USA.
Nadolny P; 7 Bioinformatics Operations and Systems, Allergan Inc, Irvine, CA, USA.
Young S; 8 Strategic Consulting Services, Medidata Solutions, Conshohocken, PA, USA.
Given K; 9 Strategic Consulting Services, Medidata Solutions, Edison, NJ, USA.
Florin L; 10 Consulting Partnerships, Medidata Solutions, Conshohocken, PA, USA.

Ther Innov Regul Sci ; 48(6): 671-680, 2014 Nov.

Article em En | MEDLINE | ID: mdl-30227471

Palavras-chave

data integrity; quality control; risk-based monitoring; source data review; source data verification

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Idioma: En Ano de publicação: 2014 Tipo de documento: Article

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