|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||List||Displayed Query||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.||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.|
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|