representing device data in cdisc standards · pdf filecdisc sdtm implementation guide for...
Post on 27-Feb-2018
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CDISC SDTM implementation guide for medical devices
Originally developed for devices under study
Also works well for other device use cases
Relating device/subject records in CDISC SDTM
A record for the imaging procedure itself
Many records for the scanner identifiersand scan parameters
One or more records for the finding(s) on imaging
A record forthe tracer
administration
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