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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MHCAT Hidden/pre-populated
PSORIASIS HISTORY
Record the date of diagnosis of plaque psoriasis using this format (DD-MON-YYYY).
PSORIASIS_MHSTDAT MHSTDTC where MHTERM="Plaque Psoriasis"
_________________
PSORIASIS_MHTERM MHTERM Hidden/pre-populated
Plaque Psoriasis
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>
FLARE_MHTERM MHTERM Hidden/pre-populated
Plaque Psoriasis
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"

<From NY codelist>
FLARE_MHEVLINT MHEVLINT where MHTERM="Plaque Psoriasis" Hidden/pre-populated
-P6M
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).
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

<From NY codelist>
Record the end date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).
FLARE_MHENDAT MHENDTC where MHTERM="Plaque Psoriasis"
_________________
View CRF Metadata
OrderTAUG ReferenceCDASH Variable CDASH Variable Label Question TextPromptData TypeCase Report Form Completion InstructionsSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Codelist NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0MHCATCategory for Medical HistoryWhat was the category of the medical history?Medical History CategoryTextN/AMHCATMHCATN/ASponsor-defined Controlled Terminology

PSORIASIS HISTORY 



Y
2

PSOR V1.0



PSORIASIS_MHSTDATMedical History Event Start Date

What was the date of diagnosis of plaque psoriasis?

Date of DiagnosisTextRecord the date of diagnosis of

plaque psoriasis using this format (DD-MON-YYYY).		MHSTDTC

MHSTDTC where MHTERM="Plaque Psoriasis"

N/A













3PSOR V1.0

PSORIASIS_MHTERM

Medical History Event Reported TermWhat is the medical condition or event term?Medical History TermTextN/AMHTERMMHTERMN/A



Plaque Psoriasis



Y
4PSOR V1.0PSORIASIS_MHEVDTYPMedical History Event Date TypeWhat was the medical history event date type?Medical History Event Date TypeTextN/AMHEVDTYPMHEVDTYP where MHTERM="Plaque Psoriasis"N/A



DIAGNOSIS



Y
5PSOR V1.0PSORIASIS_MHPRESPMedical History Event Pre-SpecifiedN/AN/ATextN/AMHPRESP

MHPRESP where MHTERM="Plaque Psoriasis"

(NY)



Y

radioY
6PSOR V1.0PSORIASIS_MHOCCUROCCURRENCE

N/A

N/ATextN/AMHOCCURMHOCCUR where MHTERM="Plaque Psoriasis"(NY)



Y

radioY
7PSOR V1.0FLARE_MHTERMMedical History Event Reported TermN/AMedical History TermTextN/AMHTERMMHTERMN/A



Plaque Psoriasis



Y
8PSOR V1.0FLARE_MHEVDTYPMedical History Date TypeWhat was the medical history event date type?Medical History Event Date TypeTextN/AMHEVDTYP

MHEVDTYP where MHTERM="Plaque Psoriasis"

N/A



FLARE EPISODE



Y
9PSOR V1.0FLARE_MHPRESPMedical History Event Pre-SpecifiedN/AN/ATextN/AMHPRESPMHPRESP where MHTERM="Plaque Psoriasis"N/A



Y

radioY
10PSOR V1.0FLARE_MHOCCUROCCURRENCE

Did the subject have a flare in the last 6 months?

Psoriasis Flare in Last 6 MonthsTextIndicate if the subject had a flare, or flares, in the last 6 months.MHOCCURMHOCCUR where MHTERM="Plaque Psoriasis"(NY)

Yes;No



radio

11PSOR V1.0FLARE_MHEVLINTEvaluation IntervalWhat is the duration of interval associated with an observation?Evaluation IntervalTextN/AMHEVLINT

MHEVLINT where MHTERM="Plaque Psoriasis"

N/A



-P6M



Y
12PSOR V1.0FLARE_MHCRNORD

N/AChronological OrdertextN/ANSMH.MHCRNORDNSMH.MHCRNORD where MHTERM="Plaque Psoriasis"





MOST RECENT



Y
13PSOR V1.0FLARE_MHSTDATMedical History Event End DateWhat was the start date of the last psoriasis flare?Start DateTextRecord the start date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).MHSTDTCMHSTDTC where MHTERM="Plaque Psoriasis" N/AThe sponsor may choose to capture a complete date or any variation thereof (e.g., month & year or year, etc.). 



prompt



14PSOR V1.0MHONGOOngoingIs the most recent flare ongoing?OngoingTextRecord if the most recent flare is ongoing at the time of data collection and the end date should be left blank.MHENRF;  MHENRTPTMHENRF or MHENRTPT(NY)

Yes;No



checkbox

15PSOR V1.0FLARE_MHENDATMedical History Event End DateWhat was the end date of the last psoriasis flare?End DateTextRecord the end date of the most recent psoriasis flare during the last 6 months using this format (DD-MON-YYYY).MHENDTCMHENDTC where MHTERM="Plaque Psoriasis" N/AThe sponsor may choose to capture a complete date or any variation thereof (e.g., month & year or year, etc.). 



prompt