Diabetes History 1

Illustrates Domains

MH

Illustrates Variables

MHEVDTYP


Content


Subjects enrolled in this study can have either T1DM or T2DM.

Annotated CRF: Diabetes History


Enter the date of diagnosis of diabetes.
MHSTDAT MHSTDTC
_ _ / _ _ _ / _ _ _ _
MHEVDTYP Hidden/pre-populated
DIAGNOSIS
Select the specific type of diabetes. Type of Diabetes
MHTERM
MHPRESP Hidden/pre-populated
MHOCCUR Hidden/pre-populated
MHCAT Hidden/pre-populated
DIABETES
View CRF Metadata
Question TextPromptTypeCDASH Variable NameCDASH CoreSDTM Variable NameSDTM CoreCase Report Form completion instructionsMapping InstructionsImplementation InstructionsPermissible ValuesPre-specified ValueHide?
Date of Diagnosis of DiabetesDiagnosis DatedateMHSTDATHRMHSTDTCPermEnter the date of diagnosis of diabetes. Map directly to SDTM. 
Also maps to QVAL in SUPPMH with QNAM= MHDXDTC and QLABEL= Date of Diagnosis 
Full Date Optional, Year expected.


N/AN/AtextMHEVDTYPOMHEVDTYPPerm

DIAGNOSIS
DIAGNOSISY
Type of Diabetes
textMHTERMHRMHTERMReqSelect the specific type of diabetes. Map directly to SDTMExamples of codelist could be "Type 1 Diabetes" and "Type 2 Diabetes", which types to collect is a judgment to be made by the sponsor.  Type 1 Diabetes;Type 2 Diabetes

N/AN/AbooleanMHPRESPR/CMHPRESPPermPre-specified = YMap directly to SDTMWhen MHTERM is pre-specified, this value is "Y".
YY
N/AN/AbooleanMHOCCURR/CMHOCCURPerm
Map directly to SDTMWhen MHTERM is pre-specified, this value is "Y".
YY
N/AN/AtextMHCATR/CMHCATPermPre-specified = DIABETESMap directly to SDTM

DIABETESY
 

This example shows two different subjects, one with T1DM and the other with T2DM. The start of the condition was considered to be the date of diagnosis (as opposed to symptom onset, or first identifiable hyperglycemic episode, or any other milestone by which the diabetes might have been considered to "start"), so MHEVDTYP="DIAGNOSIS" to indicate that MHSTDTC has been populated with the date of diagnosis.

mh.xpt

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHTERMMHEVDTYPMHCATMHPRESPMHOCCURMHDTCMHSTDTC
1XYZMHXYZ-001-0011TYPE 1 DIABETESDIAGNOSISDIABETESYY2010-09-262010-03-25
2XYZMHXYZ-001-0021TYPE 2 DIABETESDIAGNOSISDIABETESYY2010-10-262010-04-25