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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 (See Section 2.10 Standards for Data Exchange).

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

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