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).

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).
TUDAT TUDTC and TRDTC
_ _ / _ _ _ / _ _ _ _
TULOC Pre-populated
sponsor-defined

<From LOC codelist>

Sponsor-specified What was the Lesion ID?
TULNKID TULNKID and TRLNKID
Specify the laterality of the lesion. If applicable, what was the laterality of the anatomical location?
TULAT

<From LAT codelist>

Specify the directionality of the lesion. If applicable, what was the directionality of the anatomical location?
TUDIR

<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.
TULOCDTL NSTU.TULOCDTL
_________________
Record the longest diameter of the target lesion.
LDIAM_TRORRES TRORRES where TRTESTCD="LDIAM"
. __.__
LDIAM_TRORRESU TRORRESU where TRTESTCD="LDIAM" Pre-populated
mm

<From UNIT codelist>

View CRF Metadata
OrderTAUG ReferenceCDASH Variable NameQuestion TextPromptTypeCase Report Form Completion InstructionsSDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology CodeList NameCRF Implementation NotesPre-Populated ValuePermissible ValuesListDisplayed QueryHidden
1PSOR V1.0LESIDENT_TUORRESWhat type of lesions are being identified as defined by the criteria being employed?Lesion Type According to Criteriatext
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.TARGETN/A

y
2PSOR V1.0TUDATWhat was the date of examination used for lesion identification?

Lesion Identification Date

dateRecord the physical exam date used to identify the lesion using this format (DD-MON-YYYY).TUDTCTUDTC and TRDTCN/ARecord the date of the physical examination. If photographs are used to identify lesions, the date of the photograph may be used.




3PSOR V1.0TULOCWhat was the anatomical location of the target lesion?Location textSpecify 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





4PSOR V1.0TULNKIDWhat was the Lesion ID?Tumor ID textSponsor-specifiedTULNKIDTULNKID and TRLNKIDN/AThis 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


5PSOR V1.0TULATIf applicable, what was the laterality of the anatomical location?Laterality textSpecify the laterality of the lesion.TULAT
(LAT)See TULOC; the response "NOT APPLICABLE" is not submitted in the SDTM dataset.
RIGHT;LEFT;NOT APPLICABLE


6PSOR V1.0TUDIRIf applicable, what was the directionality of the anatomical location?Directionality textSpecify the directionality of the lesion.TUDIR
(DIR)See TULOC; the response "NOT APPLICABLE" is not submitted in the SDTM dataset.
UPPER;LOWER;NOT APPLICABLE


7PSOR V1.0TULOCDTLIf applicable, what were additional details about the lesion location?Location Detail textProvide 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/AUse 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.




8PSOR V1.0

LDIAM_TRORRES

What was the longest diameter of the target lesion?

Longest Diameterfloat  

Record the longest diameter of the target lesion.

TRORRESTRORRES where TRTESTCD="LDIAM"N/ATarget 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.




9PSOR V1.0LDIAM_TRORRESUWhat were the units for the longest diameter?Longest Diameter Unit text N/ATRORRESUTRORRESU where TRTESTCD="LDIAM"(UNIT)Usually the unit of the test is predefined on the CRF.mm