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Using NCI Controlled Terminology for Standardizing Data

Posted by Kevin Burges on Feb 5, 2018 4:30:00 PM

Use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and ADaM standardize the structures to use when collecting and submitting data, but what about the data values themselves?

This post gives an overview of CDISC's standardized controlled terminology and how it should be used to collect and submit data in a way that speeds trials and enables cross study analysis.

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Topics: CDISC, Controlled Terminology, Regulatory, SDTM, SEND, Submissions, ADaM

Controlled Terminology and CDASH

Posted by Fiona Hartley on Oct 15, 2015 4:33:07 PM

Because the focus of CDASH (Clinical Data Acquisition Standards Harmonization) is on data collection, not data reporting, it works a little differently from the rest of the CDISC content standards. Since there is a disconnect between collection and reporting, the point of CDASH is to bridge that gap by showing how data should be collected, minimizing the disparity with reporting.

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Topics: CDASH, CDISC, Controlled Terminology, CRFs, SDTM