Recently, PhUSE and CDISC announced the completion of Phase I of the FDA/PhUSE Semantic Technology Working Group Project. The PhUSE Semantic Technology Working Group aims to investigate how formal semantic standards can support the clinical and non-clinical trial data life cycle from protocol to submission. This deliverable includes a draft set of existing CDISC standards represented in RDF.

In this stage of the project, the focus is on describing meta-models and models that describe and allow flexible use of the standards. This important first step was created out of an industry-regulator collaboration initiated through PhUSE and supported by many CDISC volunteers who originally developed these foundational standards.

The ADaM representation of this project was co-led by Phil Ashworth, semantic solution architect at TopQuadrant, with Josephine Gough and contributions from Nate Freimark, Dave Jordan, Kirsten Langendorf and Mitra Rocca. ADaM is the last standard in the food chain when it comes to presenting the results of a clinical trial for revision by the authorities. Designed to standardize the way that analysis results are stored and thus presented to authorities, ADaM provides standards for statistical analyses to reduce and eliminate any processing required by the reviewer. 

According to Phil, the current diverse set of standards leave the understanding of data and data relationships more open to interpretation. This initiative will create a more efficient, accurate way of representing and submitting data to the FDA and allowing data to be analyzed based on a common model where the meaning is well understood. For more details on Phil’s involvement in this project, read this wiki on ADaM in RDF standards.

In the next stage of this project, PhUSE and CDISC will take a closer look at demonstrating the capture of information based on these initial models and then submitting to the FDA. Additional information about this project can be found on the PhUSE wiki.

Through our collaboration with PhUSE and CDISC, we hope to enable quicker decision-making for life science professionals. At TopQuadrant, we understand they need to simply and readily bring data together and view, explore and analyze it.