Page History

The associated SDTM datasets for the data collected above are provided below. The An abbreviated  Tobacco Product Identifier Identifiers and Descriptors (TO) domain which example is provided for reference below. TO provides a mechanism for uniquely identifying a tobacco product was used.  Only , and is the source of the SPTOBID variable.  For more information on this domain, see  section 3.1.1, Tobacco Product Identifiers and Descriptors. Only one tobacco product was of interest in the study. 

...

The sponsor used a standardized or dictionary-derived text for the description of an issue or events. CDISC does not provide information on prescribe what standardized or dictionary-derived text should be used). 

The sponsor decided to use the International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes. Annex A ( 2022) provides the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. EMDECOD was the Level 3 IMDRF term. Non-standard variables were used to represent the various coding level variables defined in the dictionary. ( NOTE: Meta Example to be confirmed with someone - RM. )

Example SUPPEM  Variable Metadata

...