Page History

...

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

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. PIDECODE was the Level 3 IMDRF term. Non-standard variables were used to represent the various coding level variables defined in the dictionary. 

...