FDA / PhUSE CSS Initiative

Report
WG1: OpenCDISC Validator Update
March 18-19, 2012
Sergiy Sirichenko/ OpenCDISC
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
OpenCDISC v1.4, March 14th, 2013
• Support for SDTM 1.3 model and SDTMIG v3.1.3
• Compliance with CDER Common Data Standards
Issues Document
• Performance and scalability enhancements for
large studies
• Simplified management of multiple CDISC
Contolled Terminology versions
• Over 100 new validation rules
• Updates to SDTM, SEND, and ADaM rules
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Changes in All SDTM Validation Profiles
Severity of 6 rules were changed from Warning
to Error
• Value for not found in user-defined codelist
• Inconsistent values for --TEST/--TESTCD
• Variable appears in dataset, but is not in SDTM
standard
• Missing AGEU, when AGE is provided and
otherwise
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Changes in All SDTM Validation Profiles
Severity of 3 rules were changed from Error to
Warning
• Missing value for --STTPT, when --STRTPT is
populated
• Same for --ENTPT/--ENRTPT
• Non-ASCII or non-printable characters in variable
(--TEST, --TESTCD, --PARM, --PARMCD, QLABEL,
QNAM)
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Changes in All SDTM Validation Profiles
Messages or/and descriptions were changed in
12 rules for better diagnostics:
• SD0002, SD0006, SD0007, SD0008, SD0019,
SD0020, SD0035, SD0065, SD1017, SD1018,
SD1021, SD1023, SD1026, SD1029, SD1039,
SD1040, SD1053, SD1055, SD1056
• e.g. SD1017
Old Message: “Invalid VISITNUM”
New Message: “VISITNUM value does not match TV
domain data”
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Changes in All SDTM Validation Profiles
• Rule SD0007 was extended to ensure consistency
of --STRESU variable value within
(--TESTCD/--CAT/--METHOD/--SPEC) variables value
• Rule SD0007 was applied to additional domains
PE, SC, DA, MB, MS, PC, PP, FA and custom
Findings
• Rule SD1021 (leading space characters) was
modified to make exception for COVALn and
TSVALn variables
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
New Rules
SDTM 3.1.1
+92
SDTM 3.1.2
+90
SD1063-SD1116, SD1201, SD2201- SD2235, CT0081 CT0085
SDTM 3.1.3
361 total
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
New Metadata Rules
Extended “Core” values are introduced for
validation purpose
•
•
•
•
•
Model Permissible – Information
Not Recommended – Warning
Prohibited – Error
SEND Only – Error
FDA Expected - Warning
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
New Metadata Rules
• Variable is in wrong order within Domain
• Variable length is too long for actual data
Severity based on “excessive” chars in var length
2-5 Chars – Information
6-20 Chars – Warning
>20 Chars – Error
• Dataset is greater than 1 GB in size - Warning
• Dataset is not present in define.xml - Error
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Expected DY variable, when DTC is collected
• Missing --DY variable, when --DTC variable is
present
• --DY variable value is not populated
• --DY variable value is imputed
• Incorrect value for --DY variable
Same for –STDTC/--STDY and –ENDTC/--ENDY
All Rules are Warnings
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Expected safety data and trial design domains
EX (Exposure)
AE (Adverse Events)
DS (Disposition)
LB (Lab Test Results)
VS (Vitals Signs)
SE (Subjects Elements)
TA (Trial Arms)
TE (Trial Elements)
TS (Trial Summary)
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Expected Trial Summary Parameters
35 Trial Summary Parameters are required or
conditionally requied in study data
• SDTM IG 3.1.3 – Errors
• SDTM IG 3.1.2 – Warnings
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Some Other New Rules
• No Treatment Emergent Flag info for Adverse
Event in SUPPAE
• Duplicate USUBJID/--DECOD/--STDTC record
e.g., same AEs cannot have same start date
• Missing --CAT value, when --SCAT value is
populated
• CDISC CT paired codelists - Errors
e.g., VSTEST and VSTESTCD values should have the same
Code in CDISC CT
•Performance
and
scalability
enhancements
for large Issues
studiesDocument
•Compliance
with
CDER Common
Data Standards
•Simplified
management
of multiple
CDISC Contolled
Terminology
•Performance
and scalability
enhancements
for large
studies versions
•Over
100 newmanagement
validation rules
•Simplified
of multiple CDISC Contolled Terminology versions
•Updates
to SDTM,
SEND, and
ADaM rules
•Over 100
new validation
rules
•Updates to SDTM, SEND, and ADaM rules
Other Updates
• SDTM IG 3.1.2 Amendment 1 profile was
retired and replaced by SDTM IG 3.1.3
standard profile
• Minimal changes in ADaM validation profile

similar documents