Body Sites of Psoriasis Involvement at Baseline aCRF

Illustrates Domains

TU

Illustrates Variables

TUTEST
TUORRES
TULOC
TULAT
TUDIR

Content

This example CRF was used to collect information on sites of psoriasis disease at the baseline visit. Note: The body locations included are examples only. Sponsors may collect general locations (e.g., limbs, folding joints) or specific locations. This CRF was designed to use 1 page per area of involvement.

CRF Instructions: Use one page per affected area.

TUTEST Hidden/pre-populated
Lesion Identification

<From TUTEST codelist>
TUORRES Hidden/pre-populated
DISEASE SITE
Record the body location which has plaque psoriasis involvement. What was the location of psoriasis lesion involvement?
TULOC TULOC where TUTESTCD="LESIDENT"

<From LOC codelist>
Specify the laterality of the lesion. If applicable, what was the laterality of the anatomical location?
TULAT TULAT where TUTESTCD="LESIDENT"

<From LAT codelist>
Specify the directionality of the lesion. If applicable, what was the directionality of the anatomical location?
TUDIR TUDIR where TUTESTCD="LESIDENT"

<From DIR codelist>
View CRF Metadata
OrderTAUG ReferenceCDASH VariableQuestion TextPromptTypeCase Report Form Completion InstructionsSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Codelist NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0TUTESTWhat was the lesion identification test name?Lesion Identification Test NametextRecord the name of the TU test, if not printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.TUTESTTUTEST(TUTEST)Required to identify to which test the result relates. It is recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.

Lesion Identification



y
2PSOR V1.0TUORRESN/AResulttextN/ATUORRES

N/A



DISEASE SITE



Y
3PSOR V1.0TULOC

What was the location of psoriasis lesion involvement?

Anatomical LocationtextRecord the body location which has plaque psoriasis involvement.TULOCTULOC where TUTESTCD="LESIDENT"

(LOC)

Collected or preprinted when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location. A location detail text field (TULOCDTL) is conditional for entry (i.e., can be left blank) and allows the study site to specify the lesion in its own terms; it also can be used to distinguish tumors/lesions within the same location if other location qualifiers are not specific enough.



Scalp;Skin of the Face;Skin of the Ear;Skin of the Neck;Skin of the Back; Skin of the Upper Limb; Skin of the Lower Limb;Skin of the Bending Joint;Skin Fold;Mucosa;Skin of the Trunk;Skin of the Palm;Skin of the Sole;Nail Bed









4PSOR V1.0TULATIf applicable, what was the laterality of the anatomical location?

Side

textSpecify the laterality of the lesion.TULATTULAT where TUTESTCD="LESIDENT"(LAT)May be preprinted or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.RIGHT;LEFT;NOT APPLICABLE







5PSOR V1.0TUDIRIf applicable, what was the directionality of the anatomical location?Directionality

Specify the directionality of the lesion.TUDIRTUDIR where TUTESTCD="LESIDENT"(DIR)See TULOCANTERIOR;POSTERIOR;NOT APPLICABLEN/Aquestion text radiovisible