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CDISC / Submission Studio
SDTM/ADaM mapping, Pinnacle 21 validation and submission packages.
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Forecast
Studies mapped
18
SDTM datasets
112
ADaM ready
47
Validation errors
19
SDTM Mapping Workbench — ONCO-204
Generate SDTM datasets
Source variable
SDTM domain
SDTM variable
AI?
Validation
AGE
DM
AGE
AI
Valid
SEX_CODE
DM
SEX
AI
Valid
AE_TERM
AE
AETERM
—
Valid
AE_START_DT
AE
AESTDTC
AI
Warning
LAB_VAL
LB
LBORRES
AI
Valid
CONMED
CM
CMTRT
AI
Error
ADaM dataset builder
Link to SAP
ADSL
Subject-level analysis · 84 variables
Ready
ADAE
Adverse events · 142 variables
Ready
ADTTE
Time-to-event (PFS, OS) · 96 variables
Ready
ADLB
Lab analysis · 78 variables
In review
ADCM
Concomitant meds · 54 variables
Draft
Pinnacle 21 validation console
Run full validation
SD0001 ·
AESTDTC
Error
Open
Missing required start date · 12 records
SD0091 ·
CMTRT
Warning
Open
Non-coded term in CONMED · 4 records
AD0014 ·
ADSL.AGE
Note
Fixed
Derivation matches DM.AGE · 0 records
SD0188 ·
LBORRES
Error
Waived
Unit mismatch with terminology · 7 records
Submission package builder
Assemble submission
define.xml
Complete
SDTM datasets (12)
Complete
ADaM datasets (5)
In progress
Reviewer's guide
Drafting
Annotated CRF (aCRF)
Complete
Validation report
In progress