Page History
This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger. The sponsor did not collect device events for the heatstick used in the System Holder and Charger. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. DEDCODE was the Level 3 IMDRF term.
Example ML Variable Metadata [MLDECOD]DE Variable Metadata
Variable | Label | Type | Codelist | ||
|---|---|---|---|---|---|
| DEIMDRCD | IMDRF Code | DEDECOD | Standardized Meal Name | text | IMDRFANNEXA |
| DEIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA | ||
| DEIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
...
| Dataset wrap | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
...
Overview
Content Tools