Every Study is Special! - Governing Data Standards

The definition of data standards aligned with CDISC is just the start of a journey. Once standards have been defined, they need to be implemented on each study according to the protocol in data collection, tabulation and analysis. Roche governs the Global Data Standards for all of these areas with a cross-functional committee managed by the Data Standards Office (DSO). The committee is made up of five core teams each supporting a different area of the standards. Each study team, where necessary, submits requests for approval for deviations from the current standards to be implemented at a study level. In addition to deviations for individual studies requests are also received for the development of new standards. All requests are evaluated by the DSO and then brought before the Governance Committee for a decision and actioned as appropriate.