Mapping instructions in the CDASHIG metadata tables provide more complete guidance than that in the CDASH Model. When domain-level metadata are not available, consult the CDASH Model for SDTM mapping instructions.
Implementers must refer to the CDASH to create alternative text that may be used that meets CDASH conformance rules.
All domains should have at least one timing variable - CDASH section 3.6
Implementers must determine what additional data fields to add to address study-specific and therapeutic area requirements, and applicable regulatory and business practices. See Section 3.4, How to Create New Data Collection Fields When No CDASHIG Field Has Been Defined, for more information on how to create data collection fields that have not already been described in this implementation guide.
Overview
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