Diabetes History 1

Illustrates Domains

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.	Diagnosis Date MHSTDAT MHSTDTC	_ _ / _ _ _ / _ _ _ _
	MHEVDTYP Hidden/pre-populated	DIAGNOSIS
Select the specific type of diabetes.	Type of Diabetes MHTERM	Type 1 Diabetes Type 2 Diabetes
	MHPRESP Hidden/pre-populated	Y = Yes N = No
	MHOCCUR Hidden/pre-populated	Y = Yes N = No
	MHCAT Hidden/pre-populated	DIABETES

View CRF Metadata

Question Text	Prompt	Type	CDASH Variable Name	CDASH Core	SDTM Variable Name	SDTM Core	Case Report Form completion instructions	Mapping Instructions	Implementation Instructions	Permissible Values	Pre-populated Value	Hidden
Date of Diagnosis of Diabetes	Diagnosis Date	date	MHSTDAT	HR	MHSTDTC	Perm	Enter 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/A	N/A	text	MHEVDTYP	O	MHEVDTYP	Perm			DIAGNOSIS		DIAGNOSIS	Y
Type of Diabetes		text	MHTERM	HR	MHTERM	Req	Select the specific type of diabetes.	Map directly to SDTM	Examples 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/A	N/A	boolean	MHPRESP	R/C	MHPRESP	Perm	Pre-specified = Y	Map directly to SDTM	When MHTERM is pre-specified, this value is "Y".		Y	Y
N/A	N/A	boolean	MHOCCUR	R/C	MHOCCUR	Perm		Map directly to SDTM	When MHTERM is pre-specified, this value is "Y".		Y	Y
N/A	N/A	text	MHCAT	R/C	MHCAT	Perm	Pre-specified = DIABETES	Map directly to SDTM			DIABETES	Y

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.

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Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHTERM	MHEVDTYP	MHCAT	MHPRESP	MHOCCUR	MHDTC	MHSTDTC
1	XYZ	MH	XYZ-001-001	1	TYPE 1 DIABETES	DIAGNOSIS	DIABETES	Y	Y	2010-09-26	2010-03-25
2	XYZ	MH	XYZ-001-002	1	TYPE 2 DIABETES	DIAGNOSIS	DIABETES	Y	Y	2010-10-26	2010-04-25