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to describe expectations for use of controlled terminology and formats across standards.

TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. Controlled terminology is required to be used as specified in this guide.

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Storing controlled terminology lists for synonym qualifiers

• For events such as adverse events and medical history, populate --DECOD with the dictionary's preferred term and populate --BODSYS with the preferred body system name. If a dictionary is multi-axial, the value in --BODSYS should represent the system organ class (SOC) used for the sponsor's analysis and summary tables, which may not necessarily be the primary SOC. Populate --SOC with the dictionary-derived primary SOC. In cases where the primary SOC was used for analysis, --BODSYS and --SOC are the same.
• If MedDRA is used to code events, the intermediate levels in the MedDRA hierarchy should also be represented in the dataset. A pair of variables has been defined for each of the levels of the hierarchy other than SOC and Preferred Term (PT): one to represent the text description and the other to represent the code value associated with it. For example, --LLT should be used to represent the Lowest Level Term text description and --LLTCD should be used to represent the Lowest Level Term code value.
• For concomitant medications, populate CMDECOD with the drug's generic name and populate CMCLAS with the drug class used for the sponsor's analysis and summary tables. If coding to multiple classes, follow Section 4.2.8.1, Multiple Values for an Intervention or Event Topic Variable, or omit CMCLAS.
• For concomitant medications, supplemental qualifiers may be used to represent additional coding dictionary information (e.g., a drug's ATC codes from the WHO Drug Dictionary; see Section 8.4, Relating Non-standard Variable Values to a Parent Domain).

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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