Developing a CDISC Intelligence Quotient


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View on CDISC

In an exclusive to PharmaVOICE, Kathryn Roy, VP of Marketing at Phase Forward Inc., discusses what CDISC-compliant really means and outlines the factors that should be considered when developing a CDISC strategy. Some CDISC members envision a time in the future when at least three of the CDISC standards will be combined into one. Until then, the question remains: what does CDISC-compliant mean to you?
“People tend to refer to CDISC as though it is monolithic: ‘We are CDISC compliant,’ ” says Kathryn Roy, VP of marketing at Phase Forward Inc. “This is like saying, ‘I’m good at gambling’ when all someone knows is blackjack.”
There are four distinct CDISC data models — LAB, for exchanging lab data; ODM, the Operational Data Model; SDTM, the Study Data Tabulation Model; and ADaM, the Analysis Dataset Model — that ultimately will support the end-to-end data flow of clinical trials, from the sources into an operational database, through analysis to regulatory submission. The sources of data that are relevant to CDISC vary among patient records (i.e., case report form data), clinical laboratory data, data from CROs, shared data between companies, and other sources.
“By breaking down the components of CDISC, people can better understand what it really means to comply with the standards today and the implications of future CDISC implementation plans,” Ms. Roy says…

What Is CDISC?
Relationship of CDISC Standards
Data Coverage by Standard
Data Format by Standard
Lab Data Exchange
SDTM Coverage

Expert on this Topic
Kathryn Roy,
VP of Marketing, Phase Forward Inc.