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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. 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. 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 standardized or dictionary-derived text for the description of an issue or events. (Note: CDISC does not prescribe what standardized or dictionary-derived text should be used.) The applicant decided to use the International Medical Device Regulators Forum (IMDRF) document 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 was the Level 3 IMDRF term. NSVs were used to represent the various coding level variables defined in the dictionary.
Example SUPPEM Variable Metadata
Variable | Label | Type | Codelist |
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EMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
Codelist | External Dictionary Name | Dictionary Version | Reference |
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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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The SUPPEM dataset is used to represent the NSVs used for coding the malfunction or event. The parent domain (RDOMAIN) is EM, and IDVAR is EMSEQ. 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 (EMSEQ) equals the value specified in IDVARVAL.
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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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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.
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Team needs to decide : The level of modelling devices. We can model the single device with no components and collect AE related to the single device ( electronic cigarette ) . or we can model the components of the device ( a mouthpiece or drip tip, a cartridge (tank), a heating element or atomizer, which is sometimes accompanied by a clearomizer, and a battery.))
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Order | CDASHIG Variable | Question Text | Prompt | Data Type | CRF Completion Instructions | SDTMIG Target | SDTM Variable Mapping | Controlled Terminology Codelist Name | Permissible Values | Pre-populated Value | Query Display | List Style | Hidden | 1 | SPDEVID | What device experienced the event? | Device Experienced Event | text | Indicate the device that was involved in the incident. | SPDEVID | HTDDEV | radio | 2 | DESPID | What is the device event identifier? | Device Event Identifier | text | DESPID | Sponsor-defined | Y | 6 | DETERM | Describe the device event. | Device Event | text | Record a description of the device event that occurred. | DETERM | 7 | DESTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY). | DESTDTC | 10 | DEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the incident occurred. | DEPATT | Single Event; Intermittent; Continuous | radio | 11 | DEACNDEV | What action was taken with the study device? | Action Taken With Device | text | Record what action was taken with the device as a result of the incident. | DEACNDEV | (DEACNDEV) | No change; Device replaced; | radio | 12 | DEAENO(n) | What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | text | Record the ID of the primary AE associated with the device event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC | ||
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1 | TOB07 | DI | HTDDEV | 1 | DEVTYPE | Device Type | Heatstick System Holder and Charger | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2 | TOB07 | DI | HTDDEV | 2 | MANUF | Manufacturer | Reliable Devices | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3 | TOB07 | DI | HTDDEV | 3 | MODEL | Model Number | 700XYZ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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The RELREC dataset was used to record the relationship between the EM dataset and any reported AE represented in the AE dataset.
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