This is an example of a study where the sponsor collected issues and events associated with the operation of the electronic cigarette device 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.
| SPTOBID Pre-populated | VAPE-Z01 | ||
| Record a description of the event that occurred. | PITERM | _________________ | |
| Record the date that the event first occurred or was noted using this format (DD-MON-YYYY). | PISTDAT PISTDTC | _________________ | |
| Record how often the event occurred. | How frequently did the event occur? PIEPATT PIPATT | ||
| Record what action was taken with the device as a result of the event. | What action was taken with the device? PIACNDEV | <DEACNDEV codelist> | |
| Record the ID of the primary AE associated with event, if any. | PIAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC | _________________ |
The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain which provides a mechanism for uniquely identifying a tobacco product was used. Only one product was of interest in the study.
These product issues and events 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.
The sponsor used standardized or dictionary-derived text for the description of an issue or events. CDISC does not provide information on what standardized or dictionary-derived text should be used (if any) .
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) 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.
( NOTE: Meta Example to be confirmed with someone - RM. )
Example SUPPPI Variable Metadata
| Variable | Label | Type | Codelist |
|---|---|---|---|
| PIIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| PIIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| PIIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
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 PI dataset is shown below;
Below is the dataset, SUPPPI, used to represent the non-standad varibables used for coding the issue or event. The parent domain (RDOMAIN) is PI, and IDVAR is PISEQ. 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.
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 for brevity.
The RELREC dataset was used to record the relationship between the Product Issues and Events (PI) dataset and any reported AE represented in the AE dataset.
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