Pancreatic Cancer Medical History aCRF

Illustrates Domains

Illustrates Variables

SREL
MHEVINTX
CMEVINTX

Content

This is an example of medical history collected in a pancreatic cancer study. Such a CRF may be used to collect information about a subject's adenocarcinoma pancreatic cancer history. Sponsors may collect other details about the type of cancer (e.g., ductal, non-ductal adenocarcinoma) than are shown here.

Record the date of pathologic diagnosis.	What was the date of pathological diagnosis? MHSTDAT MHSTDTC	_________________
	Medical History Event Date Type MHEVDTYP Hidden/pre-populated	PATHOLOGICAL DIAGNOSIS <From MHEVDTYP codelist>
Record if the subject has pancreatic exocrine insufficiency.	Does the subject have pancreatic exocrine insufficiency? EPI_MHOCCUR MHOCCUR where MHTERM = " Pancreatic Exocrine Insufficiency"	Yes No <From NY codelist>
	Reported Term for the Medical History EPI_MHTERM MHTERM Hidden/pre-populated	Pancreatic Exocrine Insufficiency
Record if the subject had non-insulin-dependent diabetes.	Did the subject have non-insulin-dependent diabetes? NIDIAB_MHOCCUR MHOCCUR where MHTERM = " Non-insulin-dependent Diabetes"	Yes No <From NY codelist>
	Reported Term for the Medical History NIDIAB_MHTERM MHTERM Hidden/pre-populated	Non-insulin-dependent Diabetes
Record if the subject had insulin-dependent diabetes.	Did the subject have insulin-dependent diabetes? IDIAB_MHOCCUR MHOCCUR where MHTERM = " Insulin-dependent Diabetes"	Yes No <From NY codelist>
	Reported Term for the Medical History IDIAB_MHTERM MHTERM Hidden/pre-populated	Insulin-dependent Diabetes

View CRF Metadata

Order	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	SDTMIG Target Variable Mapping	Controlled Terminology Codelist Name	Permissible Values	Pre-populated Value	Hidden
1	text	MHSTDAT	What was the date of pathological diagnosis?	Pathological Diagnosis Date	Record the date of pathologic diagnosis.	MHSTDTC
2	text	MHEVDTYP	N/A	Medical History Event Date Type	N/A	MHEVDTYP		(MHEVDTYP)		PATHOLOGICAL DIAGNOSIS	Y
3	text	EPI_MHOCCUR	Does the subject have pancreatic exocrine insufficiency?	Pancreatic Exocrine Insufficiency Occurrence	Record if the subject has pancreatic exocrine insufficiency.	MHOCCUR	MHOCCUR where MHTERM = "Pancreatic Exocrine Insufficiency"	(NY)	Yes;No
4	text	EPI_MHTERM	N/A	Reported Term for the Medical History	N/A	MHTERM				Pancreatic Exocrine Insufficiency	Y
5	text	NIDIAB_MHOCCUR	Did the subject have non-insulin-dependent diabetes?	Non-insulin-Dependent Diabetes Occurrence	Record if the subject had non-insulin-dependent diabetes.	MHOCCUR	MHOCCUR where MHTERM = "Non-insulin-dependent Diabetes"	(NY)	Yes;No
6	text	NIDIAB_MHTERM	N/A	Reported Term for the Medical History	N/A	MHTERM				Non-insulin-dependent Diabetes	Y
7	text	IDIAB_MHOCCUR	Did the subject have insulin-dependent diabetes?	Insulin-Dependent Diabetes Occurrence	Record if the subject had insulin-dependent diabetes.	MHOCCUR	MHOCCUR where MHTERM = "Insulin-dependent Diabetes"	(NY)	Yes;No
8	text	IDIAB_MHTERM	N/A	Reported Term for the Medical History	N/A	MHTERM				Insulin-dependent Diabetes	Y