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Many terms are synonyms of other terms. When there are multiple terms that express the same base concept, SEND controlled terminology provides the preferred term to include in a submission, and thus the term to which the synonymous term(s) should be mapped. The NCI Thesaurus (https://ncit.nci.nih.gov) provides the synonyms. For instance, the unit of degrees Celsius could be expressed as "°C", "degC", "C", "Degrees Celsius", and so on. The SEND preferred term for degrees Celsius is "C." Temperature can also be expressed in terms of degrees Fahrenheit, but this is a different concept from degrees Celsius. The key to mapping is determining which terms are synonymous, not which terms can be converted into one another via a conversion factor (for conversion, see Section 4.5.1.4, Example of Original and Standardized Results and Test Not Done).

Finding the submission value for a source value can be done in 2 ways. First, searching the controlled terminology list can determine whether the source value is in the list. If it is not, the easiest way to search for synonyms is the NCI Thesaurus. The NCI Thesaurus's search functionality searches terms and synonyms and provides the SEND submission value (preferred term).

This example illustrates mapping source units into their controlled terminology preferred term for --ORRESU. Note that in each case, there is only a label change (no conversion calculation).

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).

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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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