...
Definitions were agreed for root variables, rather than domain-specific variables. For general observation class domains, all the variables that appear in the general observation class tables (Timing, Identifiers, Findings, Findings About, Events, and Interventions) are considered root variables, whether they start with two hyphens or not. The identifiers for AP domains are also considered root variables. In other SDTM tables, variables that start with the domain code are considered instantiations of a root variable with a name that starts with two hyphens in place of the the domain code, although there are a few exceptions, described below. Some of those root variables are included in the general observation class tables. For example, DISEQ is considered an instantiation of the general observation class variable --SEQ. Other root variables never explicitly appear in the SDTM with a two-hyphen name. For instance, TSPARM, TXPARM, ACPARM, DIPARM, and OIPARM are all considered instantiations of the root variable --PARM, although the text of the SDTM does not include the charater string "--PARM". Variables in the non-general observation class domains include many that do not start with a two-character domain code. Some of these are root variables in the general observation class domains (e.g., STUDYID, VISIT), while others are considered root variables, whether they appear in a single domain (e.g., LEVEL and PARENT in RELSPEC) or in multiple domains (e.g., IDVAR, IDVARVAL).
...
- The variables IETESTCD, IETEST, IECAT, and IESCAT in the TI domain do not start with the domain code "TI", so would appear to be root variables. However, they are considered to be instantiations of the root variables --TESTCD, --TEST, --CAT, and --SCAT respectively.
- The variable SPEC in RELSPEC does not start with a two-letter domain code (RELSPEC doesn't have a two-letter domain code), but is nevertheless considerd considered to be an instantiation of the root variable --SPEC.
- The variable TAETORD in TA starts with the two-letter domain code, but is nevertheless considered to be an instantiation of the timing variable TAETORD in the general observation classes,e
Batch 2
Batch 2 includes variables from all the SDTM v2.0 tables, even though SDTM v2.0 has not yet been released. Variables which were defined in Batch 1 and which do not appear outside the scope of Batch 1 (general observation class variables and Demographics) are not in Batch 2.
...