QC Workflow Optimisation

The clinical study analysis and reporting QC process has not changed in decades. It is widely agreed that there is significant overhead in using double programming, and that this may need to be revisited to accelerate and optimally use programming resources. This process has not been revisited or analysed within a modern context. The purpose of this Working Group project would be to perform this analysis and report findings.

The QC process has significant impact on the adoption of Git in statistical programming, specifically in the complexity in using Git in a way that does not disrupt the QC process. This will also impact on what is perceived as acceptable level of QC for submissions by the industry, including regulators.