wg1: opencdisc validator update
DESCRIPTION
WG1: OpenCDISC Validator Update. March 18-19, 2012 Sergiy Sirichenko/ OpenCDISC. 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 - PowerPoint PPT PresentationTRANSCRIPT
WG1: OpenCDISC Validator Update
March 18-19, 2012
Sergiy Sirichenko/ OpenCDISC
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
•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
•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
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
•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
•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
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)
•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
•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
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. SD1017Old Message: “Invalid VISITNUM”New Message: “VISITNUM value does not match TV domain data”
•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
•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
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
•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
•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
New Rules
SDTM 3.1.1+92
SDTM 3.1.2+90SD1063-SD1116, SD1201, SD2201- SD2235, CT0081 - CT0085
SDTM 3.1.3361 total
•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
•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
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
•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
•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
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 – Information6-20 Chars – Warning>20 Chars – Error
• Dataset is greater than 1 GB in size - Warning• Dataset is not present in define.xml - Error
•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
•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
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/--ENDYAll Rules are Warnings
•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
•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
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)
•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
•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
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
•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
•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
Some Other New Rules
• No Treatment Emergent Flag info for Adverse Event in SUPPAE
• Duplicate USUBJID/--DECOD/--STDTC recorde.g., same AEs cannot have same start date
• Missing --CAT value, when --SCAT value is populated
• CDISC CT paired codelists - Errorse.g., VSTEST and VSTESTCD values should have the same Code in CDISC CT
•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
•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
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
•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
•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