Identification of Target Lesions and Measurements aCRF

Illustrates Domains

TU
TR

Illustrates Variables

TUORRES
TULNKID
TULOCDTL
TRORRES
TRORRESU

Content

Three target lesions were assessed at baseline and at each study visit. Each target lesion had to be a minimum of 5 cm at its longest axis and not located on the skin of the elbow or knee. The investigator assigned identifiers to these target lesions, so that measurements taken at subsequent visits could be associated with those at baseline.

This example CRF was designed so that one page is completed for each of the target lesions identified (e.g., target 01, target 02, target 03).

	Lesion Type According to Criteria LESIDENT_TUORRES TUORRES where TUTESTCD="LESIDENT" Hidden/pre-populated	TARGET
Record the physical exam date used to identify the lesion using this format (DD-MON-YYYY).	Lesion Identification Date TUDAT TUDTC and TRDTC	_ _ / _ _ _ / _ _ _ _
	Location TULOC Pre-populated	sponsor-defined <From LOC codelist>
Sponsor-specified	What was the Lesion ID? TULNKID TULNKID and TRLNKID	TARGET 01 TARGET 02 TARGET 03
Specify the laterality of the lesion.	If applicable, what was the laterality of the anatomical location? TULAT	RIGHT LEFT NOT APPLICABLE <From LAT codelist>
Specify the directionality of the lesion.	If applicable, what was the directionality of the anatomical location? TUDIR	UPPER LOWER NOT APPLICABLE <From DIR codelist>
Provide additional detail on the exact location of the lesion, so that it can be distinguished from other lesions in the same anatomical location.	If applicable, what were additional details about the lesion location? TULOCDTL NSTU.TULOCDTL	_________________
Record the longest diameter of the target lesion.	What was the longest diameter of the target lesion? LDIAM_TRORRES TRORRES where TRTESTCD="LDIAM"	.__.__
	Longest Diameter Unit LDIAM_TRORRESU TRORRESU where TRTESTCD="LDIAM" Pre-populated	mm <From UNIT codelist>

View CRF Metadata

Order	TAUG Reference	CDASH Variable Name	Question Text	Prompt	Type	Case Report Form Completion Instructions	SDTMIG Target Variable	SDTMIG Target Mapping	Controlled Terminology CodeList Name	CRF Implementation Notes	Pre-Populated Value	Permissible Values	Hidden
1	PSOR V1.0	LESIDENT_TUORRES	What type of lesions are being identified as defined by the criteria being employed?	Lesion Type According to Criteria	text		TUORESS	TUORRES where TUTESTCD="LESIDENT"		Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. When TUTESTCD=TUMIDENT (Tumor Identification), values of TUORRES will be: TARGET, NON-TARGET, NEW TARGET, NEW NON-TARGET, DISEASE SITE.	TARGET	N/A	y
2	PSOR V1.0	TUDAT	What was the date of examination used for lesion identification?	Lesion Identification Date	date	Record the physical exam date used to identify the lesion using this format (DD-MON-YYYY).	TUDTC	TUDTC and TRDTC	N/A	Record the date of the physical examination. If photographs are used to identify lesions, the date of the photograph may be used.
3	PSOR V1.0	TULOC	What was the anatomical location of the target lesion?	Location	text	Specify the general (anatomical) location of the lesion.	TULOC		(LOC)	When anatomical location is broken down and collected as distinct pieces of data that, when combined, provide the exact location information (e.g. laterality /directionality), additional anatomical location qualifiers should be used. The first (TULOC) should follow controlled terminology, which will enable consistency across sites. Laterality (TULAT) and directionality (TUDIR) should also be available for entry if more explicit detail can be provided. 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 within the same location if TULAT and/or TUDIR is not sufficient. Finally, Presentation Type is conditional for truly nonmeasurable lesions that are difficult to characterize with Location.	sponsor-defined
4	PSOR V1.0	TULNKID	What was the Lesion ID?	Tumor ID	text	Sponsor-specified	TULNKID	TULNKID and TRLNKID	N/A	This variable is used to provide a unique code for each identified tumor in order to link records across related domains (TU and TR). TULNKID and TRLNKID are expected to be the same across datasets. The values of TULNKID are compound values that may carry the following information: an indication of the role (or assessor) providing the data records when it is someone other than the principal investigator; an indication of whether the data record is for a target, non-target, or new tumor; and an indication of whether the tumor has split or merged. Sponsors may develop their own conventions for identifying tumors.		TARGET 01;TARGET 02;TARGET 03
5	PSOR V1.0	TULAT	If applicable, what was the laterality of the anatomical location?	Laterality	text	Specify the laterality of the lesion.	TULAT		(LAT)	See TULOC; the response "NOT APPLICABLE" is not submitted in the SDTM dataset.		RIGHT;LEFT;NOT APPLICABLE
6	PSOR V1.0	TUDIR	If applicable, what was the directionality of the anatomical location?	Directionality	text	Specify the directionality of the lesion.	TUDIR		(DIR)	See TULOC; the response "NOT APPLICABLE" is not submitted in the SDTM dataset.		UPPER;LOWER;NOT APPLICABLE
7	PSOR V1.0	TULOCDTL	If applicable, what were additional details about the lesion location?	Location Detail	text	Provide additional detail on the exact location of the lesion, so that it can be distinguished from other lesions in the same anatomical location.	NSTU.TULOCDTL		N/A	Use if TULOC and TULAT and/or TUDIR values cannot provide uniqueness from other tumor records. TULOCDTL is not meant to replace TULOC, TULAT, and/or TUDIR or to serve as the free-text description field for TULOC (e.g., Location, Other). May also be useful if sponsor collects cancer antigens or tumor markers as Non-Target Lesions. See TULOC.
8	PSOR V1.0	LDIAM_TRORRES	What was the longest diameter of the target lesion?	Longest Diameter	float	Record the longest diameter of the target lesion.	TRORRES	TRORRES where TRTESTCD="LDIAM"	N/A	Target lesions should have measurements. Some sponsors opt to record measurements for new lesions and, more rarely, non-target lesions. Leverage diameter/diameter unit as appropriate per study needs.
9	PSOR V1.0	LDIAM_TRORRESU	What were the units for the longest diameter?	Longest Diameter Unit	text	N/A	TRORRESU	TRORRESU where TRTESTCD="LDIAM"	(UNIT)	Usually the unit of the test is predefined on the CRF.	mm