myCSG © |Area: SDTM| Concept: TU : Tumor/Lesion Identification | Lesson: LONCEX06 : Tumor/Lesion Identification - Investigator tumor identification, tumor results and response data using RECIST 1.1 |

  • Consists of data and programming for one of the oncology specific SDTM domains, TU:
  • Non-target lesion identification at screening
  • Target lesion identification at screening
  • Non-target lesion assessment during postbaseline period
  • Target lesion assessment during postbaseline period
  • Evaluation for new lesions during postbaseline period
  • Target, non-target and overall response assessment during postbaseline period
  • Related lessons are :
    • SDTM_TU_LONCEX06
    • SDTM_TR_LONCEX06
    • SDTM_RS_LONCEX06

TUYN : Tumor Assessment YN?
Question Response
Were target tumors identified?
[TARG_TUYN]
Yes
No
Were non-target tumors identified?
[NONTARG_TUYN]
Yes
No




TUTGSC : Tumor Assessment - Target - Screening (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

T01
T02
T03
T04
T05
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]

INVESTIGATOR
Longest Diameter
[LDIAM_TRORRES]
Longest Diameter Unit
[LDIAM_TRORRESU]

mm




TUTG : Tumor Assessment - Target (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

T01
T02
T03
T04
T05
Select if changes to tumor were identified
[TUCHANGE]
Method of Evaluation
[TUMETHOD]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Tumor Identification Evaluator
[TUEVAL]

INVESTIGATOR
Longest Diameter
[LDIAM_TRORRES]
Longest Diameter Unit
[LDIAM_TRORRESU]

mm
Check if the diameter was too small to measure
[TRTOOSM]
Check if the tumor was inevaluable
[TRINEVAL]
If the tumor was inevaluable, what was the reason?
[TRREASND]




TUNT : Tumor Assessment - Non-Target (RECIST v1.1)
NOT DONE
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

NT01
NT02
NT03
NT04
NT05
Method of Evaluation
[TUMETHOD]
CT SCAN
MRI
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]

INVESTIGATOR
Tumor State
[TUMSTATE_TRORRES]

Present
Absent
For previously identified new lesions,
Check if the tumor was inevaluable
[TRINEVAL]

Inevaluable
Check if the tumor was inevaluable
[TRINEVAL]

Inevaluable
NOT DONE
If the tumor was inevaluable, what was the reason?
[TRREASND]


If the tumor was inevaluable, what was the reason?
[TRREASND]






TUNTSC : Tumor Assessment - Non-Target - Screening (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]




TUNW : Tumor Assessment - New (RECIST v1.1)
NEW02
NEW03
NEW04
NEW05
Question Response
Line Number
[TUSPID]
State of the tumor
[TUMSTATE_TRORRES]
Is this an assessment on previously identified lesion?
[TUPLEYN]
Tumor ID
[TULNKID]

NEW01
Is this an assessment on previously identified lesion?
[TUPLEYN]
State of the tumor
[TUMSTATE_TRORRES]
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]

CT SCAN
MRI
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]




RSYN : Disease Response YN?
Question Response
Was the response assessment performed?
[RSPERF]

Yes
No




RS_REC : Disease Response (RECIST 1.1)
Question Response
Response Date
[RSDAT]
Target Response
[TRGRESP_RSORRES]
CR
PR
SD
PD
Non-target Response
[NTRGRESP_RSORRES]
CR
Non-CR/Non-PD/PD
Overall Response
[OVRLRESP_RSORRES]
CR
PR
SD
PD
NE
Response Evaluator
[RSEVAL]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_TUNTSCFORM_TUTGSCFORM_TUNW
_ STUDYID Study Identifier Char Populate as 'ONCstatschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'TU'
_ USUBJID Unique Subject Identifier Char Populate by concatenating the text "statschoice-" as prefix to the value in SUBJECT variable.
_ TUSEQ Sequence Number Num Sort the records using USUBJID, TUTESTCD, TUMETHOD, TUDTC, TULNKID and set to 1 on the first record of subject and increment by 1 on subsequent records.
_ TUREFID Reference ID Char Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNTSC-" as a prefix to the 4 character string created using RECORDPOSITION. Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNTSC-" as a prefix to the 4 character string created using RECORDPOSITION. Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNW-" as a prefix to the 4 character string created using RECORDPOSITION.
_ TUSPID Sponsor-Defined Identifier Char Populate using TUSPID Populate using TUSPID Populate using TUSPID
_ TULNKID Link ID Char Populate using TULNKID Populate using TULNKID Populate using TULNKID
_ TUTESTCD Tumor/Lesion ID Short Name Char Populate as 'TUMIDENT' Populate as 'TUMIDENT' Populate as 'TUMIDENT'.
Note: Use only the records with TUPLEYN="No".
_ TUTEST Tumor/Lesion ID Test Name Char Populate as 'Tumor Identification' Populate as 'Tumor Identification' Populate as 'Tumor Identification'
_ TUORRES Tumor/Lesion ID Result Char Populate as 'NON-TARGET' Populate as 'NON-TARGET' Populate as 'NEW'
_ TUSTRESC Tumor/Lesion ID Result Std. Format Char Populate as SDTM.TU.TUORRES
_ TULOC Location of the Tumor/Lesion Char Populate with the values from TULOC Populate with the values from TULOC Populate with the values from TULOC
_ TULAT Laterality Char Populate with the values from TULAT Populate with the values from TULAT Populate with the values from TULAT
_ TUMETHOD Method of Identification Char Populate with the values from TUMETHOD Populate with the values from TUMETHOD Populate with the values from TUMETHOD
_ TUEVAL Evaluator Char Populate with the values from TUEVAL Populate with the values from TUEVAL Populate with the values from TUEVAL
_ TUEVALID Evaluator Identifier Char Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen. Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen. Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen.
_ VISITNUM Visit Number Num Populate using FOLDERSEQ
_ VISIT Visit Name Char Populate using FOLDERNAME
_ TUDTC Date/Time of Tumor/Lesion Identification Char Populate using TUDAT after converting it to ISO 8601 format. Populate using TUDAT after converting it to ISO 8601 format. Populate using TUDAT after converting it to ISO 8601 format.
_ TUDY Study Day of Tumor/Lesion Identification Num Derive using SDTM.DM.RFSTDTC and SDTM.TU.TUDTC. When TUDTC is before RFSTDTC, populate using the difference between TUDTC and RFSTDTC. When TUDTC is on or after RFSTDTC, add 1 to the difference between TUDTC and RFSTDTC.
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