Understanding new CDISC data standards for clinical trials

The growing importance of CDISC as a standard for the exchange of clinical trial data cannot be stressed enough — FDA reviewers currently allocate too much of their time reorganizing large amounts of data submitted in various formats. In a September 2013 statement, the FDA announced that it would be moving toward developing industry guidance on the use of CDISC data standards, as it “envisions a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care.”

UC San Diego Extension is offering a new course this Winter quarter focusing on CDISC. We sat down with instructor Sunil K. Gupta, Principal SAS CDISC Consultant and industry expert for the CDISC review of medical devices, and got his thoughts on the utility of this system:

What is CDISC?
Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data.

Why is CDISC an important system to learn?
The requirements for standardizing dataset structure and variables names must be understood through a variable mapping process.

What kind of jobs can students with knowledge of CDISC look for?
Statistical SAS Programmer and Clinical Data Management Programmer are a couple examples of typical jobs in this industry.

What do you expect the future job outlook to be like?
I expect the demand for SAS programmers with CDSIC education will continue to grow as CDISC becomes required for all clinical studies both in pharmaceutical and medical device industries.

What would you like students to gain from this course?
Students can expect to improve their skills with tools for applying the CDISC standards when processing clinical data used for FDA submissions.

Taught by Gupta, the new course “CDISC: Standards in SDTMs and ADaMs” will teach students how CDISC can improve the FDA’s ability to evaluate data submissions and efficiently release new discoveries to the public. The first offering of this class is set to begin Monday, January 27.