Jason Housley , Head - Data Standards, GSK

The CDISC UK Group held a teleconference in October to discuss CDISC Harmonisation. The following is a synopsis of the call.

CDISC Harmonisation - Building the ATM of Clinical Research

In terms of standards development we have made great progress over the last two decades, but we still have much to do. Across the industry, sponsor ‘Standards’ functions are required to design their own bespoke ‘interpretations’ of the CDISC frameworks to ensure consistent, intra-company implementations. While these company implementations are compliant to the CDISC frameworks, they are generally quite different across companies; a long way from the semantically interoperable vision to which we aspire. This heterogeneity is expensive to maintain and inherently inefficient. A working group with representatives across the industry met with CDISC’s Leadership Team to discuss this issue amongst other topics. The meeting was highly engaging, energetic and very positive. Since then a project proposal has been drafted and submitted to TransCelerates Ideation Portal. If endorsed, the goal of the project will be to move to generating beginning-to-end content for use by the industry e.g., common data assets like demography, adverse events, concomitant meds will have a standard CRF, SDTM, ADaM and potentially TFL renders. The renders will have very limited flexibility and will be expected to be used by the industry ‘off the shelf’. Assuming the project proves successful, we will move to consider how these metadata can be centrally governed and made available to all, electronically.