Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: New Lesion
Show domain info
Primary Domain
TR
All Domains
TR, TU
# Question Response
1
Lesion Number
field_001
2
Date of Assessment
field_002
3
Anatomical Location
field_003
4
Anatomical Location Other Specify
field_004
5
Laterality
field_005
6
Directionality
field_006
7
Method of Evaluation
field_007
8
Status
field_008
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Non-target Lesion
Show domain info
Primary Domain
TR
All Domains
TR, TU
# Question Response
1
Lesion Number
field_001
2
Date of Assessment
field_002
3
Anatomical Location
field_003
4
Anatomical Location Other Specify
field_004
5
Laterality
field_005
6
Directionality
field_006
7
Method of Evaluation
field_007
8
Status
field_008
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Disease Response (RECIST 1.1)
Annotations
Domain name annotations
RS=DISEASE RESPONSE/CLIN CLASSIFICATION
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
4
Response Date
RSDAT
5
Target Response
TRGRESP_RSORRES
7
Non-target Response
NTRGRESP_RSORRES
10
Overall Response
OVRLRESP_RSORRES
11
Response Evaluator
RSEVAL
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Disease Response YN?
Annotations
Domain name annotations
TU=TUMOR IDENTIFICATION
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment - Non-Target (RECIST v1.1)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
6
Line Number
TUSPID
7
Tumor ID
TULNKID
12
Method of Evaluation
TUMETHOD
14
Date of Procedure
TUDAT
15
Evaluator
TUEVAL
16
Tumor State
TUMSTATE_TRORRES
17
Check if the tumor was inevaluable
TRINEVAL
17
For previously identified new lesions,<br> Check if the tumor was inevaluable
TRINEVAL_2
18
If the tumor was inevaluable, what was the reason?
TRREASND
No options
18
If the tumor was inevaluable, what was the reason?
TRREASND_2
No options
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment - Non-Target - Screening (RECIST v1.1)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
6
Line Number
TUSPID
7
Tumor ID
TULNKID
8
Location
TULOC
9
Laterality
TULAT
11
Method of Evaluation
TUMETHOD
13
Date of Procedure
TUDAT
14
Evaluator
TUEVAL
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment - New (RECIST v1.1)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
6
Line Number
TUSPID
7
Tumor ID
TULNKID
7
Is this an assessment on previously identified lesion?
TUPLEYN
7
State of the tumor
TUMSTATE_TRORRES
8
Location
TULOC
9
Laterality
TULAT
11
Method of Evaluation
TUMETHOD
13
Date of Procedure
TUDAT
14
Evaluator
TUEVAL
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment - Target (RECIST v1.1)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
6
Line Number
TUSPID
7
Tumor ID
TULNKID
11
Select if changes to tumor were identified
TUCHANGE
12
Method of Evaluation
TUMETHOD
14
Date of Procedure
TUDAT
15
Tumor Identification Evaluator
TUEVAL
16
Longest Diameter
LDIAM_TRORRES
17
Longest Diameter Unit
LDIAM_TRORRESU
18
Check if the diameter was too small to measure
LDIAM_TRTOOSM
19
Check if the tumor was inevaluable
TRINEVAL
20
If the tumor was inevaluable, what was the reason?
TRREASND
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment - Target - Screening (RECIST v1.1)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
6
Line Number
TUSPID
7
Tumor ID
TULNKID
8
Location
TULOC
9
Laterality
TULAT
11
Method of Evaluation
TUMETHOD
13
Date of Procedure
TUDAT
14
Evaluator
TUEVAL
15
Longest Diameter
LDIAM_TRORRES
16
Longest Diameter Unit
LDIAM_TRORRESU
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Tumor Assessment YN?
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response
Example Case Report Forms for TU domain
Sources: DB1, SDTM | Forms loaded: 11
Form: Target Lesion
Show domain info
Primary Domain
TR
All Domains
TR, TU
# Question Response
1
Lesion Number
field_001
2
Date of Assessment
field_002
3
Anatomical Location
field_003
4
Anatomical Location Other Specify
field_004
5
Laterality
field_005
6
Directionality
field_006
7
Method of Evaluation
field_007
8
What was the Diameter of the Tumo
field_008
9
What were the units for the Diame
field_009
10
Reason not measured
field_010
11
If Not Evaluable (NE), select
field_011
12
Sum of Target Lesion Diameters
field_012