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OCCDS Identifier Variables
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Variable Name
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Variable Label
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Type
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Codelist
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Controlled Terms
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Core
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SubClass ADVERSE EVENT Core
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CDISC Notes
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STUDYID
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Study Identifier
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Char
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Req
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Req
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XX.STUDYID
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USUBJID
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Unique Subject Identifier
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Char
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Req
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Req
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XX.USUBJID
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SUBJID
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Subject Identifier for the Study
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Char
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Perm
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Perm
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ADSL.SUBJID
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SITEID
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Study Site Identifier
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Char
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Perm
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Perm
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ADSL.SITEID
In addition to the above identifiers, row identifiers are included to support datapoint traceability. The combination of dataset or domain name and the relevant sequence number, when used in conjunction with USUBJID, provide datapoint traceability. There are 2 row identifier options: --SEQ or the combination of SRCDOM + SRCSEQ.
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Less commonly, rows in an OCCDS dataset are from multiple SDTM domains or from 1 or more ADaM datasets. Either the --SEQ variable from each domain can be added, or the variables SRCDOM and SRCSEQ can be used to identify the input rows.
For the ADVERSE EVENT SubClass, when data from FA is used in the ADVERSE EVENT SubClass, a unique identifier variable, such as FASEQ or FASPID, is also required for traceability
Row Identifier Variables
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