Understanding the influence of individual variables contributing to multivariate outliers in assessments of data quality

Author:

Zink Richard C.1ORCID,Castro-Schilo Laura2ORCID,Ding Jianfeng2

Affiliation:

1. TARGET PharmaSolutions; Department of Biostatistics; University of North Carolina at Chapel Hill; Chapel Hill NC USA

2. JMP Division; SAS Institute; Cary NC USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference24 articles.

1. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials;Buyse;Stat. Med.,1999

2. TransCelerate BioPharma Inc 2013 Position paper: Risk-based monitoring methodology http://transceleratebiopharmainc.com/

3. Rethinking the clinically-based thresholds of TransCelerate BioPharma for risk-based monitoring;Zink;Therap. Innov. Regul. Sci.,2018

4. Detecting fabrication of data in a multicenter collaborative animal study;Bailey;Control. Clin. Trials,1991

5. US Food & Drug Administration 2013 Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf

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