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Risk-Based Monitoring and the Need for Programmers and Statisticians

Statistical Consultancy Team


The ICH E6 on Good Clinical Practice was updated on 9 November 2016, the first addendum for 20 years. Sections 5.0 on Risk and 5.18.3 on Extent and Nature of Monitoring in particular created an increased need for Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). The details of how this may be covered and the increasing evolution of a risk in the industry have been noted. The required changes involved create a number of different team roles. These include opportunities for biostatisticians and statistical programmers - players who may not have been so directly involved in onsite monitoring, a more traditionally clinical domain.

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Topics: Risk Based Monitoring, International Conference on Harmonisation (ICH), ICHGCP E6, Centralized Monitoring, Fraud Detection, Source Data Verification (SDV), On-Site Monitoring, Visualization

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, Randomization, Serious Adverse Events (SAEs), Quality Control, CDISC, SAS Programming, Remote Monitoring, On-Site Monitoring, FDA, Visualization, Standardization, Remote Data Capture, Source Data Verification (SDV), Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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