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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. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. DEDCODE was the Level 3 IMDRF term. 

Example ML Variable Metadata [MLDECOD]

Variable

Label

Type

Codelist

DEDECODStandardized Meal NametextIMDRFANNEXA 

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

https://www.imdrf.org/consultations/imdrf-terminologies-categorized-adverse-event-reporting-aer-terms-terminology-structure-and-codes

SPDEVID
Pre-populated
HTDDEV
DESPID
Hidden/pre-populated
Sponsor-defined
Record a description of the device event that occurred.
DETERM
_________________
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).
DESTDAT DESTDTC
_________________
Record how often the incident occurred.How frequently did the event occur?
DEPATT
Record what action was taken with the device as a result of the incident.What action was taken with the study device?
DEACNDEV
<DEACNDEV codelist>
Record the ID of the primary AE associated with the device event, if any.
DEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC
_________________
OrderCDASHIG VariableQuestion TextPromptData TypeCRF Completion InstructionsSDTMIG TargetSDTM Variable MappingControlled Terminology Codelist NamePermissible ValuesPre-populated ValueQuery DisplayList StyleHidden
1SPDEVIDWhat device experienced the event?Device Experienced EventtextIndicate the device that was involved in the incident.SPDEVID


HTDDEV
radio
2DESPIDWhat is the device event identifier?Device Event Identifiertext
DESPID


Sponsor-defined

Y
6DETERM

Describe the device event.

Device EventtextRecord a description of the device event that occurred.DETERM






7DESTDATWhat was the start date when the event first occurred or was identified?Start DatetextRecord the date that the device event first occurred or was noted using this format (DD-MON-YYYY).DESTDTC






10DEPATTHow frequently did the event occur?Event FrequencytextRecord how often the incident occurred.DEPATT

Single Event; Intermittent; Continuous

radio
11DEACNDEVWhat action was taken with the study device?Action Taken With DevicetextRecord what action was taken with the device as a result of the incident.DEACNDEV
(DEACNDEV)No change; Device replaced; 


radio
12DEAENO(n)What was the identifier for the primary adverse event(s) associated with or related to this device event?Related Adverse Event IDtextRecord the ID of the primary AE associated with the device event, if any.N/AASSOCIATE WITH RELATED RECORD VIA RELREC





The associated SDTM datasets for the data collected above are provided below. The  DI domain is used to identify the device. Only one device was of interest in the study.    



di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIHTDDEV1DEVTYPEDevice TypeHeatstick System Holder and Charger
2TOB07DIHTDDEV2MANUFManufacturerReliable Devices
3TOB07DIHTDDEV3MODELModel Number

700XYZ

$warningHtml

de.xpt

xx.xpt

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

DESEQ

DETERM

DEDECOD

DEMODIFY

DEVACT

DESTDTC


DEIMDRDC

DEIMDRFL2

DEIMDRFL1

1

TB005

DE

2029

HTDDEV

1

Broken Heater

Mechanical Problem

Mechanical Problem

Device Replaced

2009-12-28


A05

Mechanical Problem

Mechanical Problem

2

TB005

DE

1059

HTDDEV

1

Won’t charge

Charging Problem

Charging Problem

Battery Replaced

2009-01-05


A0706

Charging Problem

Electrical /Electronic Property Problem

3

TB005

DE

3067

HTDDEV

1

Battery Malfunction

Battery Problem

Battery Problem

Battery Replaced

2009-01-05


A0705

Battery Problem

Electrical /Electronic Property Problem

$warningHtml

DE NSV Metadata




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