You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 35 Next »

NEED TO CONFIRM DOMAIN NAMES AND STRUCTURE and EXPECTED variables . This uses Ptoduct Identifier domain and the Product EVENTS we can not use PE letters

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.  

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
_________________
OrderCDASHIG VariableQuestion TextPromptData TypeCRF Completion InstructionsSDTMIG TargetSDTM Variable MappingControlled Terminology Codelist NamePermissible ValuesPre-populated ValueQuery DisplayList StyleHidden
1SPTOBIDWhat was the tobacco product identifier? Tobacco Product Identifier textIndicate the  device that  was associated with the event. SPTOBID


VAPE-Z01
radio
6PITERM

What was the event associated with this device?

EventtextRecord a description of the event that occurred.PITERM






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






10PIEPATTHow frequently did the event occur?Event FrequencytextRecord how often the event occurred.PIPATT

Single Event; Intermittent; Continuous

radio
11PIACNDEVWhat action was taken with the device?Action Taken With DevicetextRecord what action was taken with the device as a result of the event.PIACNDEV
(DEACNDEV)

No Change; Device Replaced;

Battery Replaced



radio
12PIAENO(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 event, if any.N/AASSOCIATE WITH RELATED RECORD VIA RELREC





The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (PI) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco.   

pi.xpt

pi.xpt

RowSTUDYIDDOMAINSPTOBIDPISEQPITESTCDPITESTPICATPIORRESPIORRESUPISTRESCPISTRESNPISTRESU
1TB005PIVAPE-Z01

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
ENDS (VAPES)

2TB005PIVAPE-Z012TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERCLOSED E-CIGARETTE
CLOSED E-CIGARETTE

3TB005PIVAPE-Z013MANUFManufacturerPRODUCT IDENTIFIERXXX VAPES USA
XXX VAPES USA

$warningHtml

Sponsor may use standardized or dictionary-derived text for the description of a device event/problem. CDISC does not provide information on what standardized or dictionary-derived text should be used. 

This 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) 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. 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. 


Example SUPPPI  Variable Metadata

Variable Label Type Codelist
PIIMDRCDIMDRF CodetextIMDRFANNEXA 
PIIMDRFL2IMDRF Level 2textIMDRFANNEXA
PIIMDRFL1IMDRF Level 1textIMDRFANNEXA


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

$titleHtml

pi.xpt

Row

STUDYID

DOMAIN

USUBJID

SPTOBID

PXXSEQ

PXXLNKID

PXXTERM

PXXDECOD

PXXMODIFY

PXXACNDEV

PXXISTDTC

1

TB005

PXXX

2029

VAPE-Z01

1


Broken Heater

Mechanical Problem

Mechanical Problem

Device Replaced

2009-12-28

2

TB005

PXXXI

1059

VAPE-Z01

1


Won’t charge

Charging Problem

Charging Problem

Battery Replaced

2009-01-05

3

TB005

PXXXX

3067

VAPE-Z01

1

1

Battery Malfunction

Battery Problem

Battery Problem

Battery Replaced

2009-01-05

Dataset Debug Message

There seem to be multiple domains (PXXX, PXXXI, PXXXX) present in the dataset.

This example illustrates how the coding information for a product issue might be represented. The parent domain (RDOMAIN) is PXX, and IDVAR is PXXSEQ. 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.

$titleHtml

supppi.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
11996001PXX2029PISEQ1PXXIMDRCDIMDR CodeAO5ASSIGNED
21996001PXX2029PISEQ1PXXIMDRL2IMDR Level 2Mechanical ProblemASSIGNED
31996001PXX2029PISEQ1PXXIMDRL1IMDR Level 1Mechanical ProblemASSIGNED
$warningHtml

Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity.  

ae.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDAESEQAELNKIDAETERMEPOCHAESTDTCAEENDTCAESTDYAEENDY
1TB005AE306711SKIN REDNESSPRODUCT EXPOSURE  2009-01-052009-01-071418

Dataset Debug Message

There are two leading, trailing, or non-breaking spaces in the dataset.

The RELREC dataset was used to record the relationship between the Product Events in PI and reported AE represented in AE dataset. 

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TB005PXX
PILNKID
ONEAEPI1
2TB005AE
AELNKID
ONEAEPI



  • No labels