Body Sites of Psoriasis Involvement at Baseline aCRF

Illustrates Domains

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.

	Lesion Identification Test Name TUTEST Hidden/pre-populated	Lesion Identification <From TUTEST codelist>
	Result 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"	RIGHT LEFT NOT APPLICABLE <From LAT codelist>
Specify the directionality of the lesion.	If applicable, what was the directionality of the anatomical location? TUDIR TUDIR where TUTESTCD="LESIDENT"	ANTERIOR POSTERIOR NOT APPLICABLE <From DIR codelist>

View CRF Metadata

Order	TAUG Reference	CDASH Variable	Question Text	Prompt	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	TUTEST	What was the lesion identification test name?	Lesion Identification Test Name	text	Record 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.	TUTEST	TUTEST	(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
2	PSOR V1.0	TUORRES	N/A	Result	text	N/A	TUORRES		N/A			DISEASE SITE			Y
3	PSOR V1.0	TULOC	What was the location of psoriasis lesion involvement?	Anatomical Location	text	Record the body location which has plaque psoriasis involvement.	TULOC	TULOC 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
4	PSOR V1.0	TULAT	If applicable, what was the laterality of the anatomical location?	Side	text	Specify the laterality of the lesion.	TULAT	TULAT 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
5	PSOR V1.0	TUDIR	If applicable, what was the directionality of the anatomical location?	Directionality		Specify the directionality of the lesion.	TUDIR	TUDIR where TUTESTCD="LESIDENT"	(DIR)	See TULOC	ANTERIOR;POSTERIOR;NOT APPLICABLE	N/A	question text	radio	visible