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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 product and any adverse events that a subject experienced as a result of the product issue or event.   

This is an example of a CRF used to collect this data. 

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No Change; Device Replaced;

Battery Replaced

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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain which These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.

These product issues malfunctions and events are represented in the Product Issues and Events Domain (PI).  EM. Events not specifically associated with the product device should not be represented in this PI domain.     

The sponsor applicant used a standardized or dictionary-derived text for the description of an issue or events. (Note: CDISC does not provide information on prescribe what standardized or dictionary-derived text should be used.). The sponsor applicant 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 terminologies for categorized adverse event reporting for 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 PIDECODE was the Level 3 IMDRF term. Non-standard variables NSVs were used to represent the various coding level variables defined in the dictionary. 

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

Example SUPPPI  Example SUPPEM Variable Metadata

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The PI SDTM EM dataset is shown below. 

Below is the dataset, SUPPPI, The SUPPEM dataset is used to represent the non-standad varibables NSVs used for coding the issue malfunction or event. The parent domain (RDOMAIN) is PIEM, and IDVAR is PISEQEMSEQ. 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 (PISEQEMSEQ) equals the value specified in IDVARVAL. 

In this study, subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below  below for brevity.  

The RELREC dataset was used to record the relationship between the Product Issues and Events (PI) EM dataset and any reported AE represented in the AE dataset.