Page History

...

There will be only 1 SUPP-- dataset for a parent dataset. Relationships between records in the SUPP-- dataset and observations in the parent dataset are specified using the key variables STUDYID, RDOMAIN (the domain code of the observation in the relationship), USUBJID or POOLID (for nonclinical studies only), along with IDVAR (the name of the variable from the parent dataset that identifies the related observation(s))

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-625

and IDVARVAL (the value of the identifying variable). IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM. When populated, IDVARVAL will contain the value of the variable described in IDVAR. Single records can be related by using a unique-record-identifier variable, such as --SPID or --SEQ, in IDVAR. Groups of records can be related by using grouping variables such as --GRPID in IDVAR. Using --GRPID can be a more efficient method of representing relationships when relating an NSV or attribution to a group of observations in the parent dataset. Variable QORIG represents where values represented in IDVARVAL originated (e.g., a value was collected via CRF). QORIG be populated with origin types for SDTM datasets described in the CDISC Define-XML standard.

...

For Interventions and Events general-observation class domains, all subjective data are assumed to be attributed to the investigator. For observations that have primary and secondary evaluations of specific qualifier variables,

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-801

applicants should put data from the primary evaluation into the parent dataset and data from the secondary evaluation into the Supplemental Qualifier datasets (SUPP--). Within each SUPP-- record, the value for QNAM should be formed by appending a "1" to the corresponding standard domain variable name. In cases where the standard domain variable name is already 8 characters in length, applicants should replace the last character with a "1" (incremented for each additional attribution).

...