History of Autoimmune Disease (other than Diabetes)

Illustrates Domains

MH

Illustrates Variables

MHOCCUR
MHEVDTYP
MHSUABTS

Content

This CRF shows subject data collection of the history of other autoimmune disease.

Title: History of Other Autoimmune Disease

Indicate if the subject had any other autoimmune diseases. Do not include any history of diabetes.	Does the subject have any history of other autoimmune diseases? ADOT1D_MHOCCUR MHOCCUR where MHTERM = "AUTOIMMUNE DISEASE OTHER THAN TYPE 1 DIABETES MELLITUS"	Yes No <From NY codelist>
	Medical History Category ADOT1D_MHCAT MHCAT Hidden/pre-populated	AUTOIMMUNE DISEASE OTHER THAN TYPE 1 DIABETES MELLITUS
Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.	What is the medical condition or event term? ADOT1D_MHTERM MHTERM	_________________
	Medical History Event Date Type ADOT1D_MHEVDTYP MHEVDTYP Hidden/pre-populated	DIAGNOSIS
Record the start date of the medical event or condition using this format (DD-MON-YYYY).	What was the date of diagnosis of the other autoimmune disease? ADOT1D_MHSTDAT MHSTDTC	_________________
	Was the medical condition supported by an antibody test? ADOT1D_MHSUABTS NSMH.MHSUABTS	Yes No <From NY codelist>

View CRF Metadata

Order Number	TAUG Reference	CDASHIG Variable	CDASHIG Variable Label	Question Text	Prompt	Data Type	Case Report Form Completion Instructions	SDTMIG Target	SDTMIG Variable Mapping	Controlled Terminology Codelist Name	CRF Implementation Notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden	Notes/Questions
10	TAUG-T1D-P&D	ADOT1D_MHOCCUR	Medical History Occurrence	Does the subject have any history of other autoimmune diseases?	Any Other Autoimmune Disease	text	Indicate if the subject had any other autoimmune diseases. Do not include any history of diabetes.	MHOCCUR	MHOCCUR where MHTERM = "AUTOIMMUNE DISEASE OTHER THAN TYPE 1 DIABETES MELLITUS"	(NY)		Yes;No			Radio
20	TAUG-T1D-P&D	ADOT1D_MHCAT	Category for Medical History	What was the category of the medical history?	Medical History Category	Text	N/A	MHCAT		N/A	Sponsor-defined Controlled Terminology		AUTOIMMUNE DISEASE OTHER THAN TYPE 1 DIABETES MELLITUS			hidden
40	TAUG-T1D-P&D	ADOT1D_MHTERM	Medical History Event Reported Term	What is the medical condition or event term?	Medical History Term	Text	Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.	MHTERM		N/A	Sponsors should collect all relevant medical conditions or events, as defined in the protocol. It is a best practice for sponsors to collect all relevant history of surgeries or procedures using the associated diagnosis in the MH domain, while reporting relevant surgeries and procedures in the SDTM PR domain. Sponsor should provide instructions on how surgeries and procedures will be handled based on the protocol requirements. Information on pre-specified surgeries, or procedures should be collected in the PR domain.
50	TAUG-T1D-P&D	ADOT1D_MHEVDTYP	Diabetes History Event Date Type	What was the medical history event date type?	Medical History Event Date Type	Text	N/A	MHEVDTYP	MHEVDTYP	N/A			DIAGNOSIS			Y
60	TAUG-T1D-P&D	ADOT1D_MHSTDAT	Medical History Event Start Date	What was the autoimmune disease start date?	What was the date of diagnosis of the other autoimmune disease?	Text	Record the start date of the medical event or condition using this format (DD-MON-YYYY).	MHSTDTC		N/A	The sponsor may choose to capture a complete date or any variation thereof (e.g., month & year or year, etc.).			prompt
70	TAUG-T1D-P&D	ADOT1D_MHSUABTS		Was the medical condition supported by an antibody test?		Text		MHSUABTS	NSMH.MHSUABTS	(NY)		Yes;No			Radio