|
SDTMIG 3.3 |
RELREC |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
RELREC |
2 |
RDOMAIN |
Related Domain Abbreviation |
Char |
(DOMAIN) |
Identifier |
Abbreviation for the domain of the parent record(s). |
Req |
|
SDTMIG 3.3 |
RELREC |
3 |
USUBJID |
Unique Subject Identifier |
Char |
|
Identifier |
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
Exp |
|
SDTMIG 3.3 |
RELREC |
4 |
IDVAR |
Identifying Variable |
Char |
|
Identifier |
Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID. |
Req |
|
SDTMIG 3.3 |
RELREC |
5 |
IDVARVAL |
Identifying Variable Value |
Char |
|
Identifier |
Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here. |
Exp |
|
SDTMIG 3.3 |
RELREC |
6 |
RELTYPE |
Relationship Type |
Char |
(RELTYPE) |
Record Qualifier |
Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. Used only when identifying a relationship between datasets (as described in Section 8.3, Relating Datasets). |
Exp |
|
SDTMIG 3.3 |
RELREC |
7 |
RELID |
Relationship Identifier |
Char |
|
Record Qualifier |
Unique value within USUBJID that identifies the relationship. All records for the same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records. |
Req |