Diabetes Complications aCRF

Illustrates Domains

MH

Illustrates Variables

MHPRESP
MHTERM
MHOCCUR
MHEVDTP

Content

	What is the medical condition or event identifier? MHSPID	_________________
	MHCAT Hidden/pre-populated	DIABETES
	MHSCAT Hidden/pre-populated	COMPLICATION
	MHPRESP Hidden/pre-populated	Y = Yes N = No
Complications are pre-specified on the CRF. For each complication listed indicate if it has occurred.	What is the medical condition or event? MHTERM
Select "Yes" or "No" to indicate if the subject experienced this condition as a result of complications from Diabetes.	Did the subject have [pre-specified medical condition]? MHOCCUR	Y = Yes N = No
Enter the start date of the complication.	Diagnosis Date MHSTDAT MHSTDTC	_ _ / _ _ _ / _ _ _ _
	MHEVDTYP Hidden/pre-populated	DIAGNOSIS

View CRF Metadata

Columns whose headers are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Field ID	Activation Trigger	Order Number	Domain	Question Text	Prompt	Input Type	CDASH Variable	CDASH Core	Case Report Form Completion Instructions	Definition	Information for Sponsors	TA Specific Usage Rules	Maps to the SDTMIG Variable	SDTMIG Core	Mapping Instructions	Controlled Terminology CodeList Name	Controlled Terminology Value	Pre-Defined Values	Value that appears on the CRF but is not entered by the user	Hidden?
				What is the medical condition or event identifier?	Sponsor Defined ID	text	MHSPID	HR			Can be pre-populated Row or Sequence Number to Identify condition (SPID)		MHSPID		Map directly to SDTM
				N/A	N/A	text	MHCAT	R/C					MHCAT	Perm	Map directly to SDTM				DIABETES	hidden
				N/A	N/A	text	MHSCAT	R/C					MHSCAT	Perm	Map directly to SDTM				COMPLICATION	hidden
				N/A	N/A	boolean	MHPRESP	O			This value field is not entered and it may be hidden from users.		MHPRESP	Perm	Map directly to SDTM				Y	hidden
				What is the medical condition or event?	Medical History Term	text	MHTERM	HR	Complications are pre-specified on the CRF. For each complication listed indicate if it has occurred.		The conditions to collect is a scientific judgment made by the sponsor. Example conditions/terms have been listed to show how chosen conditions/terms would appear in a CRF or in a dataset. Sponsor should consider coding when choosing terms.		MHTERM	Req	Map directly to SDTM			Diabetic Retinopathy; Neuropathy; Nephropathy; Peripheral Vascular Disease; Atherosclerotic Heart Disease; Diabetic Ketoacidosis; Hyperglycemic Hyperosmolar Syndrome
				Did the subject have [pre-specified medical condition]?	[Medical condition/Event]	boolean	MHOCCUR	HR	Select "Yes" or "No" to indicate if the subject experienced this condition as a result of complications from Diabetes.				MHOCCUR	Perm	Map directly to SDTM
				Date of Diagnosis	Diagnosis Date	date	MHSTDAT	HR	Enter the start date of the complication.		Full Date Optional, Year expected.		MHSTDTC	Perm	Map directly to MHSTDTC in SDTM.
				N/A	N/A	text	MHEVDTYP	O					MHEVDTYP	N/A	Map directly to SDTM				DIAGNOSIS	hidden