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Statistical Methods in Risk Based Monitoring

Statistical Consultancy Team

This blog explores the statistical methods used in Risk Based Monitoring (RBM) and how the result of such statistical methods enables improved data integrity across a clinical trial.

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Topics: Statistical Consultancy, Laboratory Datasets, ICHGCP E6, Risk Based Monitoring, Statistics, Centralized Monitoring

First Steps in Laboratory Dataset in SAS

Clinical Programming Team

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating, with multiple tests and visits per patient. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition to the standardized process of domain validation.

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Topics: Laboratory Datasets, Safety Dataset, Statistical Programming, SAS Programming, SAS, Clinical Programming, CDISC Standards, CDISC SDTM, SAS Macros, SAS Datasets, SDTM, Case Report Form (CRF), SDTM Domains, CDISC Guidelines, CDISC

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