Plaque Psoriasis Medical History aCRF

Illustrates Domains

MH

Illustrates Variables

MHEVDTYP
MHCRNORD
MHONGO

Content

This CRF was used in a study where all subject were required to have a diagnosis of plague psoriasis at entry.

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	Medical History Category MHCAT Hidden/pre-populated	PSORIASIS HISTORY
Record the date of diagnosis of plaque psoriasis using this format (DD-MON-YYYY).	What was the date of diagnosis of plaque psoriasis? PSORIASIS_MHSTDAT MHSTDTC where MHTERM="Plaque Psoriasis"	_________________
	Medical History Term PSORIASIS_MHTERM MHTERM Hidden/pre-populated	Plaque Psoriasis
	Medical History Event Date Type PSORIASIS_MHEVDTYP MHEVDTYP where MHTERM="Plaque Psoriasis" Hidden/pre-populated	DIAGNOSIS
	PSORIASIS_MHPRESP MHPRESP where MHTERM="Plaque Psoriasis" Hidden/pre-populated	Y <From NY codelist>
	PSORIASIS_MHOCCUR MHOCCUR where MHTERM="Plaque Psoriasis" Hidden/pre-populated	Y <From NY codelist>
	Medical History Term FLARE_MHTERM MHTERM Hidden/pre-populated	Plaque Psoriasis
	Medical History Event Date Type FLARE_MHEVDTYP MHEVDTYP where MHTERM="Plaque Psoriasis" Hidden/pre-populated	FLARE EPISODE
	FLARE_MHPRESP MHPRESP where MHTERM="Plaque Psoriasis" Hidden/pre-populated	Y
Indicate if the subject had a flare, or flares, in the last 6 months.	Did the subject have a flare in the last 6 months? FLARE_MHOCCUR MHOCCUR where MHTERM="Plaque Psoriasis"	Yes No <From NY codelist>
	Evaluation Interval FLARE_MHEVLINT MHEVLINT where MHTERM="Plaque Psoriasis" Hidden/pre-populated	-P6M
	Chronological Order FLARE_MHCRNORD NSMH.MHCRNORD where MHTERM="Plaque Psoriasis" Hidden/pre-populated	MOST RECENT
Record the start date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).	Start Date FLARE_MHSTDAT MHSTDTC where MHTERM="Plaque Psoriasis"	_________________
Record if the most recent flare is ongoing at the time of data collection and the end date should be left blank.	Is the most recent flare ongoing? MHONGO MHENRF or MHENRTPT	Yes No <From NY codelist>
Record the end date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).	End Date FLARE_MHENDAT MHENDTC where MHTERM="Plaque Psoriasis"	_________________

View CRF Metadata

Order	TAUG Reference	CDASH Variable	CDASH Variable Label	Question Text	Prompt	Data Type	Case Report Form Completion Instructions	SDTMIG Target Variable	SDTMIG Target Mapping	Controlled Terminology Codelist Name	CRF Implementation Notes	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	PSOR V1.0	MHCAT	Category for Medical History	What was the category of the medical history?	Medical History Category	Text	N/A	MHCAT	MHCAT	N/A	Sponsor-defined Controlled Terminology		PSORIASIS HISTORY			Y
2	PSOR V1.0	PSORIASIS_MHSTDAT	Medical History Event Start Date	What was the date of diagnosis of plaque psoriasis?	Date of Diagnosis	Text	Record the date of diagnosis of plaque psoriasis using this format (DD-MON-YYYY).	MHSTDTC	MHSTDTC where MHTERM="Plaque Psoriasis"	N/A
3	PSOR V1.0	PSORIASIS_MHTERM	Medical History Event Reported Term	What is the medical condition or event term?	Medical History Term	Text	N/A	MHTERM	MHTERM	N/A			Plaque Psoriasis			Y
4	PSOR V1.0	PSORIASIS_MHEVDTYP	Medical History Event Date Type	What was the medical history event date type?	Medical History Event Date Type	Text	N/A	MHEVDTYP	MHEVDTYP where MHTERM="Plaque Psoriasis"	N/A			DIAGNOSIS			Y
5	PSOR V1.0	PSORIASIS_MHPRESP	Medical History Event Pre-Specified	N/A	N/A	Text	N/A	MHPRESP	MHPRESP where MHTERM="Plaque Psoriasis"	(NY)			Y		radio	Y
6	PSOR V1.0	PSORIASIS_MHOCCUR	OCCURRENCE	N/A	N/A	Text	N/A	MHOCCUR	MHOCCUR where MHTERM="Plaque Psoriasis"	(NY)			Y		radio	Y
7	PSOR V1.0	FLARE_MHTERM	Medical History Event Reported Term	N/A	Medical History Term	Text	N/A	MHTERM	MHTERM	N/A			Plaque Psoriasis			Y
8	PSOR V1.0	FLARE_MHEVDTYP	Medical History Date Type	What was the medical history event date type?	Medical History Event Date Type	Text	N/A	MHEVDTYP	MHEVDTYP where MHTERM="Plaque Psoriasis"	N/A			FLARE EPISODE			Y
9	PSOR V1.0	FLARE_MHPRESP	Medical History Event Pre-Specified	N/A	N/A	Text	N/A	MHPRESP	MHPRESP where MHTERM="Plaque Psoriasis"	N/A			Y		radio	Y
10	PSOR V1.0	FLARE_MHOCCUR	OCCURRENCE	Did the subject have a flare in the last 6 months?	Psoriasis Flare in Last 6 Months	Text	Indicate if the subject had a flare, or flares, in the last 6 months.	MHOCCUR	MHOCCUR where MHTERM="Plaque Psoriasis"	(NY)		Yes;No			radio
11	PSOR V1.0	FLARE_MHEVLINT	Evaluation Interval	What is the duration of interval associated with an observation?	Evaluation Interval	Text	N/A	MHEVLINT	MHEVLINT where MHTERM="Plaque Psoriasis"	N/A			-P6M			Y
12	PSOR V1.0	FLARE_MHCRNORD		N/A	Chronological Order	text	N/A	NSMH.MHCRNORD	NSMH.MHCRNORD where MHTERM="Plaque Psoriasis"				MOST RECENT			Y
13	PSOR V1.0	FLARE_MHSTDAT	Medical History Event End Date	What was the start date of the last psoriasis flare?	Start Date	Text	Record the start date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).	MHSTDTC	MHSTDTC where MHTERM="Plaque Psoriasis"	N/A	The sponsor may choose to capture a complete date or any variation thereof (e.g., month & year or year, etc.).			prompt
14	PSOR V1.0	MHONGO	Ongoing	Is the most recent flare ongoing?	Ongoing	Text	Record if the most recent flare is ongoing at the time of data collection and the end date should be left blank.	MHENRF; MHENRTPT	MHENRF or MHENRTPT	(NY)		Yes;No			checkbox
15	PSOR V1.0	FLARE_MHENDAT	Medical History Event End Date	What was the end date of the last psoriasis flare?	End Date	Text	Record the end date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).	MHENDTC	MHENDTC where MHTERM="Plaque Psoriasis"	N/A	The sponsor may choose to capture a complete date or any variation thereof (e.g., month & year or year, etc.).			prompt