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Dataset wrap
Nameto
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1TB005TOVAPE-Z01

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
ENDS (VAPES)

2TB005TOVAPE-Z012TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERClosed E-Cigarette
Closed E-Cigarette

3TB005TOVAPE-Z013MANUFManufacturerPRODUCT IDENTIFIERXX Vapes USA
XXX Vapes USA

Sponsor may use standardized or dictionary-derived text for the description of an product device event/problem. CDISC does not provided information on the what standardized or dictionary-derived text should be used. 

This sponsor decided to use theThe 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 PIDECODE was the Level 3 IMDRF term. The coding of the problems/events may be done using other methods/dictionaries. 

( NOTE: Meta Example to be confirmed with RM. 


Example PI  Variable Metadata

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