How to Extend Metadata

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CDASH Model v1.2 provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.

CDASH Model v1.2 provides root-naming conventions for CDASHIG variables, intended to facilitate mapping to SDTMIG variables. The variables defined in the CDASH Model follow the same "--XXXX" naming convention as in the SDTM. The 2 dashes are replaced by the domain code when applied to create the CDASHIG variable. For example, --DOSFRQ is the CDASH Model variable name to for Dosing Frequency per Interval in the Interventions class. When a domain abbreviation is applied (e.g., "CM"), CMDOSFRQ is the CDASHIG variable for the frequency of the concomitant medication use. The CDASH Model includes metadata for variables used in each of the SDTM General Observation classes, Timing variables, Identifier variables, variables for special-purpose domains, and domain-specific variables. See Section 3.5.1 for specific information on this content.  

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.