Self-Monitoring Blood Glucose aCRF

Illustrates Domains

Illustrates Variables

LBTPT
LBTPTNUM

Content

Indicate whether or not SMBG was performed.	Was SMBG performed? LBPERF LBSTAT	Y = Yes N = No
Provide the name of the device used.	What was the device used? SPDEVID	_________________
	LBTEST LBTESTCD Hidden/pre-populated	GLUCOSE <From LBTEST codelist>
	Specimen Type LBSPEC Pre-populated	PLASMA <From SPECTYP codelist>
Record the date of measurement.	SMBG Date LBDAT LBDTC	_ _ / _ _ _ / _ _ _ _
	LBTPT LBTPTNUM Pre-populated	Pre-Morning Meal
Indicate if the Pre-Morning Meal measurement was performed.	Was Pre-Morning Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Pre-Morning Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Post-Morning Meal
Indicate if the Post-Morning Meal measurement was performed.	Was the Post-Morning Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Post-Morning Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Pre-Midday Meal
Indicate if the Pre-Midday Meal measurement was performed.	Was the Pre-Midday Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Pre-Midday Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Post-Midday Meal
Indicate if the Post-Midday Meal measurement was performed.	Was the Post-Midday Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Post-Midday Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Pre-Evening Meal
Indicate if the Pre-Evening Meal measurement was performed.	Was the Pre-Evening Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Pre-Evening Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTUM Pre-populated	Post-Evening Meal
Indicate if the Post-Evening Meal measurement was performed.	Was the Post-Evening Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Post-Evening Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Bedtime
Indicate if the Bedtime measurement was performed.	Was the Bedtime measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Bedtime Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
	LBTPT LBTPTNUM Pre-populated	Overnight
Indicate if the Overnight measurement was performed.	Was Overnight measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Overnight Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>
Date of measurement. Should be a programmatic representation of Day, Month, Year and not entered by a user.	SMBG Next Day Date LBDAT LBDTC	_ _ / _ _ _ / _ _ _ _
	LBTPT LBTPTNUM Pre-populated	Next Day Pre-Morning Meal
Indicate if the Next Day Pre-Morning Meal measurement was performed.	Was the Next Day Pre-Morning Meal measurement performed? LBPERF LBSTAT	Y = Yes N = No
Record the time in hh:mm format. 24 hour clock time.	Next Day Pre-Morning Meal Time LBTIM LBDTC	_ _ : _ _ : _ _
Record glucose measurement.	What was the result of the test? LBORRES	. __.__
Select the original unit in which glucose measurement was collected.	What was the unit of the lab result? LBORRESU	mg/dL mmol/L <From UNIT codelist>

View CRF Metadata

Columns whose headers are shaded blue are specific to the indication and/or form, and are not from the CDASH model or the CDASH domain metatable.

Field ID	Activation Trigger	Question Text	Prompt	Type	CDASH Variable	CDASH Core	Case Report Form completion instructions	Implementation Instructions	Maps to the SDTMIG Variable	SDTMIG Core	Mapping Instructions	Controlled Terminology Codelist Name	Pre-defined values	Pre-specified value	Hide?	TA Specific Usage Rules
LBPERF_ALL		Was SMBG performed?	SMBG Performed	boolean	LBPERF	HR	Indicate whether or not SMBG was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null. A combination of SDTMIG variables ( e.g., LBCAT and LBSCAT, LBTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided. See SDTMIG Section 4.1.5.1.2.
SPDEVID	LBPERF_ALL = "Y"	What was the device used?	Device	text	SPDEVID	O	Provide the name of the device used.	Identifier for the device used to obtain the result. This field applies to all timepoints on this CRF.	SPDEVID	Perm	Maps directly to SDTM.
LBTEST	LBPERF_ALL = "Y"	N/A	N/A	text	LBTEST	HR	N/A	Required to identify which test the result is for. This field applies to all timepoints on this CRF.	LBTEST;LBTESTCD	Req;Req	Maps directly to SDTM. The SDTMIG variable LBTESTCD may be determined from the value collected in LBTEST. The SDTMIG variables LBTESTCD and LBTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.	LBTEST		GLUCOSE	Y
LBSPEC	LBPERF_ALL = "Y"	What is the specimen material type?	Specimen Type	text	LBSPEC	O	N/A	The type of specimen used for a measure (e.g., TISSUE, BLOOD, BONE MARROW). This field applies to all timepoints on this CRF.	LBSPEC	Perm	Maps directly to SDTM.	SPECTYP		PLASMA		Agreed on populating it with PLASMA as results are reported as concentrations in plasma - disregarding if the measurement is taken from blood or plasma.
LBDAT_1_8	LBPERF_ALL = "Y"	What was the date of the lab specimen collection?	SMBG Date	date	LBDAT	HR	Record the date of measurement.	A complete date is expected. The SDTMIG variable LBDTC contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time. This field applies to timpoints 1-8 on this CRF	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
LBTPT_1	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "1". See SDTMIG for additional information on representing time points.			Pre-Morning Meal		Label of test per protocol.
1_LBPERF	LBPERF_ALL = "Y"	Was Pre-Morning Meal measurement performed?	Pre-Morning Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Pre-Morning Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
1_LBTIM	1_LBPERF = "Y"	What was the time of the lab specimen collection?	Pre-Morning Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
1_LBORRES	1_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
1_LBORRESU	1_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_2	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "2". See SDTMIG for additional information on representing time points.			Post-Morning Meal		Label of test per protocol. Post meal measurements are dependent on the study protocol.
2_LBPERF	LBPERF_ALL = "Y"	Was the Post-Morning Meal measurement performed?	Post-Morning Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Post-Morning Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
2_LBTIM	2_LBPERF = "Y"	What was the time of the lab specimen collection?	Post-Morning Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
2_LBORRES	2_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
2_LBORRESU	2_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_3	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "3". See SDTMIG for additional information on representing time points.			Pre-Midday Meal		Label of test per protocol.
3_LBPERF	LBPERF_ALL = "Y"	Was the Pre-Midday Meal measurement performed?	Pre-Midday Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Pre-Midday Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
3_LBTIM	3_LBPERF = "Y"	What was the time of the lab specimen collection?	Pre-Midday Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
3_LBORRES	3_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
3_LBORRESU	3_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_4	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "4". See SDTMIG for additional information on representing time points.			Post-Midday Meal		Label of test per protocol. Post meal measurements are dependent on the study protocol.
4_LBPERF	LBPERF_ALL = "Y"	Was the Post-Midday Meal measurement performed?	Post-Midday Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Post-Midday Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
4_LBTIM	4_LBPERF = "Y"	What was the time of the lab specimen collection?	Post-Midday Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
4-LBORRES	4_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
4_LBORRESU	4_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_5	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "5". See SDTMIG for additional information on representing time points.			Pre-Evening Meal		Label of test per protocol.
5_LBPERF	LBPERF_ALL = "Y"	Was the Pre-Evening Meal measurement performed?	Pre-Evening Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Pre-Evening Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
5_LBTIM	5_LBPERF = "Y"	What was the time of the lab specimen collection?	Pre-Evening Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
5_LBORRES	5_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
5_LBORRESU	5_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_6	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "6". See SDTMIG for additional information on representing time points.			Post-Evening Meal		Label of test per protocol. Post meal measurements are dependent on the study protocol.
6_LBPERF	LBPERF_ALL = "Y"	Was the Post-Evening Meal measurement performed?	Post-Evening Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Post-Evening Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
6_LBTIM	6_LBPERF = "Y"	What was the time of the lab specimen collection?	Post-Evening Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
6_LBORRES	6_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
6_LBORRESU	6_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_7	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "7". See SDTMIG for additional information on representing time points.			Bedtime		Label of test per protocol.
7_LBPERF	LBPERF_ALL = "Y"	Was the Bedtime measurement performed?	Bedtime Measurement Performed	boolean	LBPERF	R/C	Indicate if the Bedtime measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
7_LBTIM	7_LBPERF = "Y"	What was the time of the lab specimen collection?	Bedtime Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
7_LBORRES	7_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
7_LBORRESU	7_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBTPT_8	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "8". See SDTMIG for additional information on representing time points.			Overnight		Label of test per protocol. This is a protocol specific timepoint and should follow what the protocol states for this measurement.
8_LBPERF	LBPERF_ALL = "Y"	Was Overnight measurement performed?	Overnight Measurement Performed	boolean	LBPERF	R/C	Indicate if the Overnight measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
8_LBTIM	8_LBPERF = "Y"	What was the time of the lab specimen collection?	Overnight Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
8_LBORRES	8_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
8_LBORRESU	8_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L
LBDAT_9	LBPERF_ALL = "Y"	Next Date of Measurement	SMBG Next Day Date	date	LBDAT	HR	Date of measurement. Should be a programmatic representation of Day, Month, Year and not entered by a user.	A complete date is expected. The SDTMIG variable LBDTC contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
LBTPT_9	LBPERF_ALL = "Y"	N/A	N/A	text	LBTPT	O	N/A	Planned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.	LBTPT;LBTPTNUM	Perm	LBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "9". See SDTMIG for additional information on representing time points.			Next Day Pre-Morning Meal
9_LBPERF	LBPERF_ALL = "Y"	Was the Next Day Pre-Morning Meal measurement performed?	Next Day Pre-Morning Meal Measurement Performed	boolean	LBPERF	R/C	Indicate if the Next Day Pre-Morning Meal measurement was performed.	This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.	LBSTAT	Perm	This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.
9_LBTIM	9_LBPERF = "Y"	What was the time of the lab specimen collection?	Next Day Pre-Morning Meal Time	time	LBTIM	R/C	Record the time in hh:mm format. 24 hour clock time.	May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.	LBDTC	Exp	This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.
9_LBORRES	9_LBPERF = "Y"	What was the result of the test?	Result	float	LBORRES	HR	Record glucose measurement.		LBORRES	Exp	Maps directly to SDTM.
9_LBORRESU	9_LBPERF = "Y"	What was the unit of the lab result?	Unit	text	LBORRESU	R/C	Select the original unit in which glucose measurement was collected.		LBORRESU	Exp	Maps directly to SDTM.	UNIT	mg/dL;mmol/L