Hypoglycemia aCRF

Illustrates Domains

CE
FA
LB
EX
CM
ML


Content

CETERM Hidden/pre-populated
Hypoglycemic Event
CECAT Hidden/pre-populated
HYPO EVENTS
Indicate whether or not any hypoglycemic events occurred. Any Hypoglycemic Events Experienced?
CEYN Not submitted
CESPID
_________________
Record start date using DD-MMM-YYYY format.
CESTDAT CESTDTC
_ _ / _ _ _ / _ _ _ _
Record time using a 24 hour clock.
CESTTIM CESTDTC
_ _ / _ _ _ / _ _ _ _
Record the time period during which the hypoglycemic event occurred. When Did the Hypoglycemic Event Occur?
WHENOCC QVAL
Indicate whether or not the investigator has determined this to be an adverse event. In the Opinion of the Investigator Was This an Adverse Event?
WASAEYN FAORRES
Indicate whether or not glucose measurement obtained. If yes, enter result and unit below. Was a Glucose Measurement Obtained at the Time of the Event?
LBPERF LBSTAT
Enter result value.
LBORRES
. __.__
Enter the unit related to the result value.
LBORRESU
_________________
ECCAT or EXCAT Hidden/pre-populated
HIGHLIGHTED DOSE
Enter the name or reference to the last study medication taken.
ECTRT or EXTRT
_________________
Record the date of the last study medication taken using DD-MMM-YYYY format.
ECSTDAT or EXSTDAT ECSTDTC or EXSTDTC
_ _ / _ _ _ / _ _ _ _
Record the time of the last study medication taken using a 24 hour clock.
ECSTTIM or EXSTTIM ECSTDTC or EXSTDTC
_ _ / _ _ _ / _ _ _ _
Record the dose of the last study medication taken.
ECDSTXT or EXDSTXT ECDOSE or EXDOSE
. __.__
Record the units associated with the dose.
ECDOSU or EXDOSU
_________________
HYPOMED_CMCAT CMCAT Hidden/pre-populated
ANTI-HYPERGLYCEMIC MED
CMSCAT Hidden/pre-populated
HIGHLIGHTED DOSE
Enter the name or reference to the last concomitant diabetic medication taken
CMTRT
_________________
Record date using DD-MMM-YYYY format.
CMSTDAT CMSTDTC
_ _ / _ _ _ / _ _ _ _
Record time using a 24 hour clock.
CMSTTIM CMSTDTC
_ _ / _ _ _ / _ _ _ _
CMDSTXT CMDOSE
. __.__
CMDOSU
_________________
Record using DD-MMM-YYYY format.
MLSTDAT MLSTDTC
_ _ / _ _ _ / _ _ _ _
Record time using a 24 hour clock.
MLSTTIM MLSTDTC
_ _ / _ _ _ / _ _ _ _
SYMPTOMS_CECAT CECAT Hidden/pre-populated
HYPO SYMPTOMS
Were Signs/Symptoms Present? (If yes complete following)
CEYN Not submitted
Sweating
SWEATING_CEOCCUR CEOCCUR
Tremors/Trembling
TREMORS_CEOCCUR CEOCCUR
Dizziness
DIZZINESS_CEOCCUR CEOCCUR
Cognitive Impairment
COGNITIVE_CEOCCUR CEOCCUR
Loss of Consciousness
LOC_CEOCCUR CEOCCUR
Convulsions/Seizure
SEIZURE_CEOCCUR CEOCCUR
Coma
COMA_CEOCCUR CEOCCUR
Other (Specify)
OTHER_CEOCCUR CEOCCUR
If Other (Specify) is yes, specify the other sign/symptom
OTHER_CETERM CETERM
_________________
FACAT Hidden/pre-populated
PRECIPITATING FACTORS
FAOBJ Hidden/pre-populated
HYPOGLYCEMIC EVENT
Were Any Precipitating Factors Reported?
HPFYN Not submitted
Alcohol Consumption
ALCPF_FAORRES FAORRES
Concurrent Illness
ILLPF_FAORRES FAORRES
Deviation from Dosing Instructions
DSDVPF_FAORRES FAORRES
Missed, Delayed or Smaller Meal
MEALPF_FAORRES FAORRES
Physical Activity
PAPF_FAORRES FAORRES
Other (Specify)
OTHPF_FAORRES FAORRES
If Other (Specify) is yes, specify the other precipitating factor.
OTHPF_FATEST FATEST
_________________
HTG_CMCAT CMCAT Hidden/pre-populated
HYPO TREATMENT
Was Any Treatment Given for the Hypoglycemic Event? (If yes complete following)
HTGYN Not submitted
Drink
DRINK_CMOCCUR CMOCCUR
Food
FOOD_CMOCCUR CMOCCUR
Glucose Tablets
TABLET_CMOCCUR CMOCCUR
Glucagon Injection
INJECT_CMOCCUR CMOCCUR
Intravenous Glucose
IV_CMOCCUR CMOCCUR
Investigator assessment. If Treatment Given Indicate Assistance Needed?
FAORRES
View CRF Metadata
Question TextPromptTypeCDASH Variable NameSDTM Variable NameCase Report Form completion instructionsMapping InstructionsImplementation InstructionsPermissible ValuesPre-populated ValueHidden
N/AN/AtextCETERMCETERM
Maps directly to SDTM.Not typically entered by an investigative site.  May appear as a label or header on the case report form.  
Hypoglycemic Eventhidden
N/AN/AtextCECATCECAT
Maps directly to SDTM.Not typically entered by an investigative site.  May appear as a label or header on the case report form.  
HYPO EVENTShidden
Any Hypoglycemic Events Experienced?Any Hypoglycemic Events Experienced?booleanCEYNN/AIndicate whether or not any hypoglycemic events occurred.This variable does not map to SDTM.Primary intent/purpose of field is to help with data cleaning and monitoring.


Sponsor Defined ID
textCESPID CESPID 

Can be pre-populated Row or Sequence Number to Identify Event (SPID).


Date of Event
dateCESTDATCESTDTCRecord start date using DD-MMM-YYYY format.For SDTM-based dataset,  SDTMIG variable CESTDTC is derived by concatenating CDASH Start Date (CESTDAT) and Time (CESTTIM if time is collected) and converting to ISO 8601 format.
For more detail see the CDASH v1.1 Best Practice section.
This field does not map directly into SDTM.
CDASH recommends the unambiguous format DD-MMM-YYYY where “DD” is a 2-digit numeric value for day, “MMM” is a 3-character letter abbreviation for month, and “YYYY” is a 4-digit numeric value for year.


Time of Event
dateCESTTIMCESTDTCRecord time using a 24 hour clock.For SDTM-based dataset,  SDTMIG variable CESTDTC is derived by concatenating CDASH Start Date (CESTDAT) and Time (CESTTIM if time is collected) and converting to ISO 8601 format.
For more detail see the CDASH v1.1 Best Practice section.
This field does not map directly into SDTM.




When Did the Hypoglycemic Event Occur?
textWHENOCCQVALRecord the time period during which the hypoglycemic event occurred.QVAL when QNAM= WHENOCC and
QLABEL= "When Did the Hypoglycemic Event Occur?".
Recommend response choices:  "Between Bedtime and Waking" and "Between Waking and Bedtime".Between Bedtime and Waking; Between Waking and Bedtime

In the Opinion of the Investigator Was This an Adverse Event?Y/NbooleanWASAEYNFAORRESIndicate whether or not the investigator has determined this to be an adverse event.The response will map to FAORRES where FATESTCD= "WASAEYN", FATEST= "Was this an adverse event?" and FAOBJ="HYPOGLYCEMIC EVENT".



Was a Glucose Measurement Obtained at the Time of the Event?Y/NbooleanLBPERFLBSTAT

Indicate whether or not glucose measurement obtained.

If yes, enter result and unit below.

"Yes" response is not submitted. "No" is mapped to LBSTAT as the value "NOT DONE".

In LB domain, LBTESTCD will be "GLUC",  LBTEST will be "GLUCOSE" and a value must be assigned to LBCAT to distinguish this from other results.
Primary intent/purpose of field is to help with data cleaning and monitoring. 

The sponsor may map a response of "No" as directed to document testing that was not performed.  A response of "Yes" will not be mapped to the SDTM data.

Because this field does not map to an SDTM domain, the sponsor may assign a naming prefix according to internal conventions.




Glucose ResultfloatLBORRESLBORRESEnter result value.
 "xxx.xx" for result



Glucose UnitstextLBORRESULBORRESUEnter the unit related to the result value.
Expected values for Glucose Result Units are "mg/dL" or "mmol/L".


N/AN/AtextECCAT or EXCATECCAT or EXCAT



HIGHLIGHTED DOSEhidden
Last Study Medication TakenName/ReferencetextECTRT or EXTRTECTRT or EXTRTEnter the name or reference to the last study medication taken.Map ECTRT to EXTRT as discussed in the SDTMIG.Collection of the data related to Last Medication Taken is Optional.
Medication label can be pre-populated in question text, and section can be repeated if multiple labels . 
EXCAT= HIGHLIGHTED DOSE  required to differentiate EX records added exclusively for hypoglycemic reference.  Though this value will not typically be included as a field for entry, it may be preprinted on the CRF.
If collected, the sponsor should use variables from the EC or EX domain as appropriate for the CDISC implementation by sponsor.




DatedateECSTDAT or EXSTDATECSTDTC or EXSTDTCRecord the date of the last study medication taken using DD-MMM-YYYY format.
Optional to include if Last Medication Taken is collected.



TimedateECSTTIM or EXSTTIMECSTDTC or EXSTDTCRecord the time of the last study medication taken using a 24 hour clock.
Optional to include if Last Medication Taken is collected.



DosefloatECDSTXT or EXDSTXTECDOSE or EXDOSERecord the dose of the last study medication taken.
Include if Last Medication Taken is also collected.



UnitstextECDOSU or EXDOSUECDOSU or EXDOSURecord the units associated with the dose.
Include if Last Medication Taken Dose is collected.  May be printed.


N/AN/AtextHYPOMED_CMCATCMCAT



ANTI-HYPERGLYCEMIC MEDhidden
N/AN/AtextCMSCATCMSCAT



HIGHLIGHTED DOSEhidden
Last Concomitant Diabetic Medication TakenName/ReferencetextCMTRTCMTRTEnter the name or reference to the last concomitant diabetic medication taken
Collection of the data related to Last Concomitant Diabetic Medication Taken is Optional.
Medication(s) of interest can be pre-populated in question text.  Optional implementation would utilized a sponsor ID from CM entry to identify medication name/dose/units and only capture date/time of last dose.
CMCAT= ANTI-HYPERGLYCEMIC MED and CMSCAT = HIGHLIGHTED DOSE required to differentiate CM records added exclusively for hypoglycemic reference.  Though this value will not typically be included as a field for entry, it may be preprinted on the CRF.




DatedateCMSTDATCMSTDTCRecord date using DD-MMM-YYYY format.
Include if Last Concomitant Diabetic Medication Taken is also collected.



TimedateCMSTTIMCMSTDTCRecord time using a 24 hour clock.
Include if Last Concomitant Diabetic Medication Taken is also collected.



DosefloatCMDSTXTCMDOSE

Include if Last Concomitant Diabetic Medication Taken is also collected.



UnitstextCMDOSUCMDOSU

Include if Last Concomitant Diabetic Medication Taken Dose is also collected.


Date of Last MealDatedateMLSTDATMLSTDTCRecord using DD-MMM-YYYY format.




Time of Last MealTimedateMLSTTIMMLSTDTCRecord time using a 24 hour clock.




N/AN/AtextSYMPTOMS_CECATCECAT



HYPO SYMPTOMShidden
Were Signs/Symptoms Present?  (If yes complete following)Y/NbooleanCEYNN/A

Findings about the Hypoglycemic Event.

Does not map to SDTM.


If this question is used, then for the following signs/symptoms, it is possible to use checkboxes or only yes responses. 
If this question is not used, then both yes and no responses must be collected for each item listed.
Sponsor to decide if only  "Yes" responses retained in SDTM. 




SweatingbooleanSWEATING_CEOCCURCEOCCUR
If response is Y, the prompt "Sweating" will populate SDTM variable CETERM.  CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.  
Use of a coding dictionary is at the sponsor's discretion.




Tremors/TremblingbooleanTREMORS_CEOCCURCEOCCUR
If response is Y, the prompt "Tremors/Trembling" will populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




DizzinessbooleanDIZZINESS_CEOCCURCEOCCUR
If response is Y, the prompt "Dizziness" will be used to populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




Cognitive ImpairmentbooleanCOGNITIVE_CEOCCURCEOCCUR
If response is Y, the prompt "Cognitive Impairment" will be used to populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




Loss of ConsciousnessbooleanLOC_CEOCCURCEOCCUR
If response is Y, the prompt "Loss of Consciousness" will be used to populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




Convulsions/SeizurebooleanSEIZURE_CEOCCURCEOCCUR
If response is Y, the prompt "Convulsions/Seizure" will be used to populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




ComabooleanCOMA_CEOCCURCEOCCUR
If response is Y, the prompt "Coma" will be used to populate SDTM variable CETERM.   CEPRESP will be populated as "Y".  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




Other (Specify)booleanOTHER_CEOCCURCEOCCUR;
If response is Y, the value entered for the Specify field will be used to populate CETERM. CEPRESP will be null.  CECAT will be populated as "HYPO SYMPTOMS".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted.
Use of a coding dictionary is at the sponsor's discretion.




Specify OthertextOTHER_CETERMCETERMIf Other (Specify) is yes, specify the other sign/symptom




N/AN/AtextFACATFACAT



PRECIPITATING FACTORShidden
N/AN/AtextFAOBJFAOBJ

FAOBJ = HYPOGLYCEMIC EVENT; number consecutively.
HYPOGLYCEMIC EVENThidden
Were Any Precipitating Factors Reported?Y/NbooleanHPFYNN/A

Findings about the Hypoglycemic Event.

Does not map to SDTM.

If this question is used, then for the following precipitating factors, it is possible to use checkboxes or only yes responses. 
If this question is not used, then both yes and no responses must be collected for each item listed.
Sponsor to decide if only  "Yes" responses retained in SDTM. 




Alcohol ConsumptionbooleanALCPF_FAORRESFAORRES
The prompt "Alcohol Consumption as a Precip Factor" will be used to populate SDTM variable FATEST.  FACAT will be populated as "PRECIPITATING FACTORS".  FAOBJ will be populated as "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Concurrent IllnessbooleanILLPF_FAORRESFAORRES
The prompt "Concurrent Illness as a Precip Factor" will be used to populate SDTM variable FATEST.    FACAT will be populated as "PRECIPITATING FACTORS".  FAOBJ will be populated as "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Deviation from Dosing InstructionsbooleanDSDVPF_FAORRESFAORRES
The prompt "Dosing Deviation as a Precip Factor" will be used to populate SDTM variable FATEST.    FACAT will be populated as "PRECIPITATING FACTORS".  FAOBJ will be populated as "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Missed, Delayed or Smaller MealbooleanMEALPF_FAORRESFAORRES
The prompt "Meal Variance as a Precip Factor" will be used to populate SDTM variable FATEST.    FACAT will be populated as "PRECIPITATING FACTORS".   FAOBJ will be populated as "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Physical ActivitybooleanPAPF_FAORRESFAORRES
The prompt "Physical Activity as a Precip Factor" will be used to populate SDTM variable FATEST.    FACAT will be populated as "PRECIPITATING FACTORS".  FAOBJ will be populated as  "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Other (Specify)booleanOTHPF_FAORRESFAORRES
If response is Y, the value in the Specify field will be used to populate SDTM variable FATEST.  (Alternately, "Other" concatenated with the data in the Specify field may be used to populate FATEST.) FATESTCD  will be "OTHER".  FAOBJ will be populated as  "HYPOGLYCEMIC EVENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Specify OthertextOTHPF_FATESTFATESTIf Other (Specify) is yes, specify the other precipitating factor.




N/AN/AtextHTG_CMCATCMCAT



HYPO TREATMENThidden
Was Any Treatment Given for the Hypoglycemic Event?   (If yes complete following)Y/NbooleanHTGYNN/A
Question used for data cleaning and does not map to SDTM.On the annotated CRF, note as Not Submitted.   If sponsor elects to submit this response recommend using CECONTRT.



DrinkbooleanDRINK_CMOCCURCMOCCUR
If response is Y, the prompt "Drink" will be used to populate SDTM variable CMTRT.  CMPRESP will be Y.   CMCAT will be "HYPO TREATMENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



FoodbooleanFOOD_CMOCCURCMOCCUR
If response is Y, the prompt "Food" will be used to populate SDTM variable CMTRT.  CMPRESP will be Y.   CMCAT will be  "HYPO TREATMENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Glucose TabletsbooleanTABLET_CMOCCURCMOCCUR
If response is Y, the prompt "Glucose Tablets" will be used to populate SDTM variable CMTRT.  CMPRESP will be Y.   CMCAT will be  "HYPO TREATMENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Glucagon Injection booleanINJECT_CMOCCURCMOCCUR
If response is Y, the prompt "Glucagon Injection" will be used to populate SDTM variable CMTRT.  CMPRESP will be Y.   CMCAT will be  "HYPO TREATMENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 



Intravenous GlucosebooleanIV_CMOCCURCMOCCUR
If response is Y, the prompt "Intravenous Glucose" will be used to populate SDTM variable CMTRT.  CMPRESP will be Y.   CMCAT will be  "HYPO TREATMENT".Expected responses are Y or N.  Yes responses will result in a record in SDTM.  Responses of N may be omitted; if they are, the annotated CRF should note that N are Not Submitted. 


If Treatment Given Indicate Assistance Needed?Need for AssistancetextFAORRESFAORRESInvestigator assessment.FACAT will be populated as "TREATMENT ADMINISTRATION".   FATESTCD= "TXASSIST",  FATEST="Treatment Assistance",  FAOBJ will be populated as  "HYPOGLYCEMIC EVENT" concatenated with consecutive numbers to differentiate between groups of findings when multiple events are reported.The sponsor may choose to collect responses to this question only if treatment for the hypoglycemic event is given. 
The expected responses are "None - Subject Treated Self", "Subject was Capable of Treating Self, but Received Assistance" and "Subject was Not Capable of Treating Self, and Required Assistance".
None - Subject Treated Self; Subject was Capable of Treating Self, but Received Assistance; Subject was Not Capable of Treating Self, and Required Assistance