CDASH. Device Exposure

Content

This is an example aCRF used to collect information on the use of a pre-specified list of devices at the time of the DKA event. The sponsor decided to categorize the devices according to their use (i.e.: devices used for management of glucose or ketones, devices used for management of insulin). The sponsor collected the information associated with each DKA event using the concept of contingency visits. Contingency visit numbers were included in the header records, but are not shown below. This CRF also includes the CDASH variable DXAENO. This variable was used by the sponsor to assign/derive the appropriate timing variables associated with the use of the SDTM TM and SM domains.

Title: DKA Event - Diabetic device used at time of the event

	DXENTPT Hidden/pre-populated	Date of visit
	Category for Device Exposure GENPMP_DXCAT DXCAT Hidden/pre-populated	INSULIN PUMP HISTORY
	Sub-category for Device Exposure GENPMP_DXSCAT DXSCAT Hidden/pre-populated	GENERAL
	Name of Device Exposure or Output GENPMP_DXTRT DXTRT Hidden/pre-populated	Any Insulin Pump Device
Indicate whether the subject has ever used an insulin pump.	Has the subject ever used an insulin pump? GENPMP_DXOCCUR DXOCCUR	Yes No
Record the date the subject first started using an insulin pump using this format (DD-MON-YYYY).	If Yes, what was the date the subject first started using an insulin pump? GENPMP_DXSTDAT DXSTDTC	_________________
Indicate whether the subject is currently using an insulin pump device.	If Yes, is the subject currently using an insulin pump? GENPMP_DXONGO If GENPMP_DXONGO = "Y", then DXENRTPT = "ONGOING" where DXCAT = "INSULIN PUMP HISTORY" and DXSCAT = "CURRENT" If GENPMP_DXONGO = "N", then DXENRTPT = "BEFORE" where DXCAT = "INSULIN PUMP HISTORY" and DXSCAT = "GENERAL"	Yes No
	Category for Device Exposure CURPMP_DXCAT DXCAT Hidden/pre-populated	INSULIN PUMP HISTORY
	Sub-category for Device Exposure CURPMP_DXSCAT DXSCAT Hidden/pre-populated	CURRENT
Indicate the type of insulin pump currently in use.	If Yes, what insulin pump is the subject currently using? CURPMP_DXTRT DIVAL DXTRT DIVAL where DIPARMCD = "SPDEVDSC" AND CURPMP_DXTRT is not "Other"	Generic Infusions PumpMatic Infusions Inc Pump Pro Other
Record the manufacturer of the insulin pump currently in use	If Other, what is the manufacturer of the insulin pump? PMPMNF_DIVAL DIVAL where DIPARMCD = "MANUF"	_________________
If insulin pump type is Other, record the trade name of the insulin pump currently in use.	If other, what is the trade name of the insulin pump? PMPMDL_DIVAL DIVAL where DIPARMCD = "TRADENAM"	_________________
	Name of Device Exposure or Output OTHPMP_DXTRT DXTRT DIVAL where DIPARMCD = "SPDEVDSC" Hidden/pre-populated	Concatenation of PMPMNF_DIVAL and PMPMDL_DIVAL
Record the date the subject started using the current insulin pump using this format (DD-MON-YYYY).	What was the start date of the current usage of the insulin pump? CURPMP_DXSTDAT DXSTDTC	_________________
	Category for Device Exposure GENCGM_DXCAT DXCAT Hidden/pre-populated	CONTINUOUS GLUCOSE MONITOR HISTORY
	Sub-category for Device Exposure GENCGM_DXSCAT DXSCAT Hidden/pre-populated	GENERAL
	Name of Device Exposure or Output GENCGM_DXTRT DXTRT Hidden/pre-populated	Any Continuous Glucose Monitoring Device
Indicate whether the subject has ever used a CGM device.	Has the subject ever used a continuous glucose monitoring (CGM) device? GENCGM_DXOCCUR DXOCCUR	Yes No
Record the date the subject first started using a CGM device using this format (DD-MON-YYYY).	If Yes, what was the start date for usage of the CGM device? GENCGM_DXSTDAT DXSTDTC	_________________
Indicate whether the subject is currently using a CGM device.	If Yes, is the subject currently using a CGM device? GENCGM_DXONGO If GENCGM_DXONGO = "Y", then DXENRTPT = "ONGOING" where DXCAT = "CONTINUOUS GLUCOSE MONITOR HISTORY" and DXSCAT = "CURRENT" If GENCGM_DXONGO = "N", then DXENRTPT = "BEFORE" where DXCAT = "CONTINUOUS GLUCOSE MONITOR HISTORY" and DXSCAT = "GENERAL"	Yes No
	Category for Device Exposure CURCGM_DXCAT DXCAT FACAT Hidden/pre-populated	CONTINUOUS GLUCOSE MONITOR HISTORY
	Sub-category for Device Exposure CURCGM_DXSCAT DXSCAT Hidden/pre-populated	CURRENT
Indicate the type of CGM device currently in use.	If Yes, what CGM device is the subject currently using? CURCGM_DXTRT DXTRT FAOBJ SPDEVID = DI.SPDEVID where DIPARMCD = "SPDEVDSC" and DIVAL = CURCGM_DXTRT	Generic Monitors CGM Standard ANOther CGMPlus
Record the date the subject started using the current CGM device using this format (DD-MON-YYYY).	What was the start date for use of the current CGM device? CURCGM_DXSTDAT DXSTDTC	_________________
Enter the total number of days the CGM was used in the last month.	For how many days has the subject used the CGM device in the last month? FAORRES FAORRES where FATESTCD = "CUMEXP" and FAOBJ = CURCGM_DXTRT	_______
	Unit FAORRESU FAORRESU where FATESTCD = "CUMEXP" and FAOBJ = CURCGM_DXTRT Hidden/pre-populated	DAYS

View CRF Metadata

Order	TAUG Reference	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTMIG Variable Mapping	Controlled Terminology Codelist Name	CRF Implementation Notes	Permissible Values	Pre-populated Value	List Style	Hidden
1	TAUG-T1D-P&D	DXENTPT	N/A	N/A	N/A	text	DXENTPT			This variable is the time point anchor for DXENRTPT		Date of visit		Y
2	TAUG-T1D-P&D	GENPMP_DXCAT		Category for Device Exposure		text	DXCAT					INSULIN PUMP HISTORY		Y
3	TAUG-T1D-P&D	GENPMP_DXSCAT		Sub-category for Device Exposure		text	DXSCAT					GENERAL		Y
4	TAUG-T1D-P&D	GENPMP_DXTRT	N/A	Name of Device Exposure or Output	N/A	text	DXTRT					Any Insulin Pump Device		Y
5	TAUG-T1D-P&D	GENPMP_DXOCCUR	Has the subject ever used an insulin pump?	Insulin Pump Used	Indicate whether the subject has ever used an insulin pump.	text	DXOCCUR		(NY)		Yes;No		radio
6	TAUG-T1D-P&D	GENPMP_DXSTDAT	If Yes, what was the date the subject first started using an insulin pump?	First Start Date of Device Exposure	Record the date the subject first started using an insulin pump using this format (DD-MON-YYYY).	text	DXSTDTC
7	TAUG-T1D-P&D	GENPMP_DXONGO	If Yes, is the subject currently using an insulin pump?	Ongoing at Study Start	Indicate whether the subject is currently using an insulin pump device.	text	DXENRTPT	If GENPMP_DXONGO = "Y", then DXENRTPT = "ONGOING" where DXCAT = "INSULIN PUMP HISTORY" and DXSCAT = "CURRENT";If GENPMP_DXONGO = "N", then DXENRTPT = "BEFORE" where DXCAT = "INSULIN PUMP HISTORY" and DXSCAT = "GENERAL"	(NY)		Yes;No		radio
8	TAUG-T1D-P&D	CURPMP_DXCAT		Category for Device Exposure		text	DXCAT					INSULIN PUMP HISTORY		Y
9	TAUG-T1D-P&D	CURPMP_DXSCAT		Sub-category for Device Exposure		text	DXSCAT					CURRENT		Y
10	TAUG-T1D-P&D	CURPMP_DXTRT	If Yes, what insulin pump is the subject currently using?	Name of Device Exposure or Output	Indicate the type of insulin pump currently in use.	text	DXTRT; DIVAL	DIVAL; DXTRT DIVAL where DIPARMCD = "SPDEVDSC" AND CURPMP_DXTRT is not "Other"		The listed devices had device identifier pre-assigned by the sponsor at the study level.	Generic Infusions PumpMatic;Infusions Inc Pump Pro; Other		radio
11	TAUG-T1D-P&D	PMPMNF_DIVAL	If Other, what is the manufacturer of the insulin pump?	Other, Pump Specify Manufacturer	Record the manufacturer of the insulin pump currently in use	text	DIVAL	DIVAL where DIPARMCD = "MANUF"		When 'Other" is indicated, the sponsor must use the collected data to assign an SPDEVID. Manufacturer and model (either model number or trade name) are often required to identify a device to a sufficient level of granularity
12	TAUG-T1D-P&D	PMPMDL_DIVAL	If other, what is the trade name of the insulin pump?	Other, Pump Specify Trade Name	If insulin pump type is Other, record the trade name of the insulin pump currently in use.	text	DIVAL	DIVAL where DIPARMCD = "TRADENAM"		When 'Other" is indicated, the sponsor must use the collected data to assign an SPDEVID. Manufacturer and model (either model number or trade name) are often required to identify a device to a sufficient level of granularity
13	TAUG-T1D-P&D	OTHPMP_DXTRT		Name of Device Exposure or Output		text	DXTRT; DIVAL:	DXTRT; DIVAL where DIPARMCD = "SPDEVDSC"				Concatenation of PMPMNF_DIVAL and PMPMDL_DIVAL		Y
14	TAUG-T1D-P&D	CURPMP_DXSTDAT	What was the start date of the current usage of the insulin pump?	Start Date of Device Exposure	Record the date the subject started using the current insulin pump using this format (DD-MON-YYYY).	text	DXSTDTC
15	TAUG-T1D-P&D	GENCGM_DXCAT		Category for Device Exposure		text	DXCAT					CONTINUOUS GLUCOSE MONITOR HISTORY		Y
16	TAUG-T1D-P&D	GENCGM_DXSCAT		Sub-category for Device Exposure		text	DXSCAT					GENERAL		Y
17	TAUG-T1D-P&D	GENCGM_DXTRT	N/A	Name of Device Exposure or Output	N/A	text	DXTRT					Any Continuous Glucose Monitoring Device		Y
18	TAUG-T1D-P&D	GENCGM_DXOCCUR	Has the subject ever used a continuous glucose monitoring (CGM) device?	Device Exposure Occurrence	Indicate whether the subject has ever used a CGM device.	text	DXOCCUR		(NY)		Yes;No		radio
19	TAUG-T1D-P&D	GENCGM_DXSTDAT	If Yes, what was the start date for usage of the CGM device?	Start Date of Device Exposure	Record the date the subject first started using a CGM device using this format (DD-MON-YYYY).	text	DXSTDTC			.
20	TAUG-T1D-P&D	GENCGM_DXONGO	If Yes, is the subject currently using a CGM device?	Ongoing at Study Start	Indicate whether the subject is currently using a CGM device.	text	DXENRTPT	If GENCGM_DXONGO = "Y", then DXENRTPT = "ONGOING" where DXCAT = "CONTINUOUS GLUCOSE MONITOR HISTORY" and DXSCAT = "CURRENT";If GENCGM_DXONGO = "N", then DXENRTPT = "BEFORE" where DXCAT = "CONTINUOUS GLUCOSE MONITOR HISTORY" and DXSCAT = "GENERAL"	(NY)		Yes;No		radio
21	TAUG-T1D-P&D	CURCGM_DXCAT		Category for Device Exposure		text	DXCAT; FACAT					CONTINUOUS GLUCOSE MONITOR HISTORY		Y
22	TAUG-T1D-P&D	CURCGM_DXSCAT		Sub-category for Device Exposure		text	DXSCAT					CURRENT		Y
23	TAUG-T1D-P&D	CURCGM_DXTRT	If Yes, what CGM device is the subject currently using?	Name of Device Exposure or Output	Indicate the type of CGM device currently in use.	text	DXTRT; FAOBJ; SPDEVID	DXTRT; FAOBJ; SPDEVID = DI.SPDEVID where DIPARMCD = "SPDEVDSC" and DIVAL = CURCGM_DXTRT		The listed devices had device identifier pre-assigned by the sponsor at the study level. The collected device description was used to retrieve the pre-assigned device identifier.	Generic Monitors CGM Standard; ANOther CGMPlus		radio
24	TAUG-T1D-P&D	CURCGM_DXSTDAT	What was the start date for use of the current CGM device?	Start Date of Device Exposure	Record the date the subject started using the current CGM device using this format (DD-MON-YYYY).	text	DXSTDTC
25	TAUG-T1D-P&D	FAORRES	For how many days has the subject used the CGM device in the last month?	Result	Enter the total number of days the CGM was used in the last month.	integer	FAORRES	FAORRES where FATESTCD = "CUMEXP" and FAOBJ = CURCGM_DXTRT
26	TAUG-T1D-P&D	FAORRESU	What was the unit?	Unit	N/A	text	FAORRESU	FAORRESU where FATESTCD = "CUMEXP" and FAOBJ = CURCGM_DXTRT				DAYS		Y