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• Variables subject to controlled terminology will be populated with the exact value for the controlled term, including term casing.
• Otherwise, text data will be represented in upper case (e.g., NEGATIVE).

• For variables where the response is "Yes" or "No", both "Y" and "N" will be   
• Variables where the response is "Yes" or "No" ("Y" or "N") should normally be populated for both "Y" and "N" responses. This eliminates confusion regarding whether a blank response indicates "N" or is a missing value. However, some variables are collected or derived in a manner that allows only 1 response, such as when a single checkbox indicates "Yes". In situations such as these, where it is unambiguous to populate only the response of interest, it is permissible to populate only 1 value ("Y" or "N") and leave the alternate value blank. An example of when it would be acceptable to use only a value of "Y" would be for Last Observation Before Exposure Flag (--LOBXFL) variables, where "N" is not necessary to indicate that a value is not the last observation before exposure.

--SEQ

• Values

• in -

• -

• The sequence number (--SEQ) variable uniquely identifies SEQ will uniquely identify a record for a given USUBJID within a domain. The variable --SEQ is required in all domains except DM. For example, if a subject has 25 observations in the Vital Signs (VS) domain, then 25 unique VSSEQ values should be established for this subject. Conventions for establishing and maintaining --SEQ values are applicant-defined. Values may or may not be sequential depending on data processes and sources.

--REFID

Values for --REFID are sponsor-defined and can be any alphanumeric strings the sponsor chooses, consistent with their internal practices.