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Terms from controlled terminology should be in the case that appears the source codelist or code system (e.g., CDISC codelist or external code system such as MedDRA). See Section 4.2.4, Text Case in Submitted Data.

Storing topic variables for general domain models

The topic variable for the Interventions and Events general observation-class models is often stored as verbatim text. For an Events domain, the topic variable is --TERM. For an Interventions domain, the topic variable is --TRT. For a Findings domain, the topic variable --TESTCD should use controlled terminology (e.g., "SYSBP" for systolic blood pressure). If CDISC Controlled Terminology exists, it should be used; otherwise, sponsors should define their own controlled list of terms. If the verbatim topic variable in an Interventions or Event domain is modified to facilitate coding, the modified text is stored in --MODIFY. In most cases—other than Physical Examination (PE)—the dictionary-coded text is derived into --DECOD. Because the PEORRES variable is modified instead of the topic variable for PE, the dictionary-derived text would be placed in PESTRESC. The variables used in each of the defined domains are:

CREATE TABLE?

Standards for tabulation require representation of dates and/or times, intervals of time, and durations of time in ISO 8601 format as defined by the International Organization for Standardization (ISO) (http://www.iso.org).  Included in specifications...

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