Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring.

de Viron, Sylviane; Trotta, Laura; Schumacher, Helmut; Lomp, Hans-Juergen; Höppner, Sebastiaan; Young, Steve; Buyse, Marc

de Viron, Sylviane; Trotta, Laura; Schumacher, Helmut; Lomp, Hans-Juergen; Höppner, Sebastiaan; Young, Steve; Buyse, Marc.

Afiliação

de Viron S; CluePoints S.A., Avenue Albert Einstein, 2a, 1348, Louvain-la-Neuve, Belgium. sylviane.deviron@CluePoints.com.
Trotta L; CluePoints S.A., Avenue Albert Einstein, 2a, 1348, Louvain-la-Neuve, Belgium.
Schumacher H; Statistical Consultant, Ingelheim Am Rhein, Germany.
Lomp HJ; Boehringer Ingelheim, Biberach an der Riss, Germany.
Höppner S; CluePoints S.A., Avenue Albert Einstein, 2a, 1348, Louvain-la-Neuve, Belgium.
Young S; CluePoints Inc., King of Prussia, USA.
Buyse M; CluePoints S.A., Avenue Albert Einstein, 2a, 1348, Louvain-la-Neuve, Belgium.

Ther Innov Regul Sci ; 56(1): 130-136, 2022 01.

Article em En | MEDLINE | ID: mdl-34590286

Assuntos

Fraude; Modelos Estatísticos

Palavras-chave

Central monitoring; Fraud; Misconduct; Risk-based monitoring; Statistical monitoring

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Modelos Estatísticos / Fraude Tipo de estudo: Clinical_trials / Diagnostic_studies / Risk_factors_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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