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• Domain datasets based on the SDTM general observations classes will be named using the 2-character code for the domain or using the applicable 4-character code when a dataset is split (e.g., LB, LBHM).
• Supplemental Qualifier

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  Supplemental Qualifier datasets will be named using convention "SUPP" concatenated withthe 2-character domain code

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  or for the parent domain (e.g., SUPPDM, SUPPFA) or the 4-character code for the parent dataset when a dataset is split (e.g., SUPPDM, SUPPFA, SUPPFACM).
• All other datasets will be named using the code for the domain or dataset (e.g., DM, RELREC). 

• Variables will be named per guidance in the SDTM. The SDTM guidance uses fragment names in the CDISC Non-Standard Variables Registry.
• Variable names in TIG domain specifications align

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  with naming conventions in the SDTM.  
• Variable names will be 8 characters or less and uppercase. 

Variable length

When variable length is referenced in the TIG, this refers to the length in bytes of ASCII character strings.

• The maximum length of character variables is 200 characters, and the full 200 characters should not be used unless necessary.

Splitting datasets

A domain dataset may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. The following conventions must be adhered to when splitting domains into separate datasets:

• A domain based on a General Observation Class may be split according to values in variable --CAT. When a domain is split on --CAT, --CAT must not be null.
• The Findings About Events or Interventions (FA) domain may be split according to values in variable the domain in which the interventions or events in --OBJ .

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  are represented (or would be represented).

To ensure split datasets can be appended back into 1 domain dataset:

• The value of DOMAIN must be consistent across the separate datasets as it would have been if they had not been split (e.g., LB, FA).
• All variables that require a domain prefix (e.g., --TESTCD, --LOC) must use the value of DOMAIN as the prefix value (e.g., LB, FA).
• --SEQ must be unique within USUBJID for all records across all the split datasets. If there are 1000 records for a USUBJID across the separate datasets, all 1000 records need unique values for --SEQ.
• When relationship datasets (e.g., SUPPxx, FAxx, CO, RELREC) relate back to split parent domains, the value of IDVAR will be from a variable with unique values for each observation. When possible, the variable represented in IDVAR will have values from collected data (e.g., SPID, RECID), but variables with derived values may also be used (e.g., --SEQ).