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This is an example of a study where the sponsor collected issues and events associated with the operation of the electronic cigarette device. Events not specifically associated with the device should not be represented in this domain.  

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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Issues and Events Identifier (PITO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco.   

The sponsor collected information on any issues or events  associated with the ENDS device. These issues and problems are  represented in the Product Issues and Events Domain (PI).  Events not specifically associated with the device should not be represented in this PI domain.     

A sponsor Sponsor may use standardized or dictionary-derived text for the description of a device event/probleman issue or events. CDISC does not provide information on what standardized or dictionary-derived text should be used. 

This In this example, 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) provide 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. The coding of the problems/issues or events may be done using other methods/ dictionaries. 

( NOTE: Meta Example to be confirmed with RM.  )

Example SUPPPI  Variable Metadata

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This example illustrates how the coding information for a product issue might be represented. Below is the dataset, SUPPPI, used to represent the non-standad varibables  used for coding the issue or event.  The parent domain (RDOMAIN) is PXXPI, and IDVAR is PXXSEQPISEQ. QNAM holds the name of the supplemental qualifier variable being defined. This only shows the data for subject 2029. The data recorded in QVAL applies to the subject’s records, where IDVAR (PISEQ) equals the value specified in IDVARVAL. 

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