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This is an example of a study where the sponsor collected 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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What was the event associated with this device?
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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 is a study reference dataset that These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.
TO provides a mechanism for uniquely identifying a tobacco product and is the source of the SPTOBID variable. Only one For more information on this domain, see Section 3.1.1, Tobacco Product Identifiers and Descriptors. Only 1 tobacco product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-121
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These product malfunctions and events are represented in EM. Events not specifically associated with the product device should not be represented in this domain.
The applicant used a Sponsor may use standardized or dictionary-derived text for the description of a device event/problem. an issue or events. (Note: CDISC does not provide information on prescribe what standardized or dictionary-derived text should be used.) This sponsor The 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) provide 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. The coding of the problems/events may be done using other methods/dictionaries.
( NOTE: Meta Example to be confirmed with RM.
NSVs were used to represent the various coding level variables defined in the dictionary.
Example SUPPEM Example SUPPPI Variable Metadata
| Variable | Label | Type | Codelist |
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| PIIMDRCDEMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| PIIMDRFL2EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| PIIMDRFL1EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
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Codelist | External Dictionary Name | Dictionary Version | Reference |
|---|---|---|---|
| IMDRFANNEXA | IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes: Annex A | Release Number: 2022 |
The SDTM EM dataset is shown below.
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This example illustrates how the coding information for a product issue might be representedThe SUPPEM dataset is used to represent the NSVs used for coding the 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.
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Subject 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 for brevity.
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The RELREC dataset was used to record the relationship between the Product Events in PI and EM dataset and any reported AE represented in the AE dataset.
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