1 / 14

WG1: OpenCDISC Validator Update

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

sirius
Download Presentation

WG1: OpenCDISC Validator Update

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. WG1: OpenCDISC Validator Update March 18-19, 2012 Sergiy Sirichenko/ OpenCDISC

  2. 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 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

  3. 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

  4. 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)

  5. 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. SD1017 Old Message: “Invalid VISITNUM” New Message: “VISITNUM value does not match TV domain data”

  6. 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 TSVALnvariables

  7. 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 +90 SD1063-SD1116, SD1201, SD2201- SD2235, CT0081 - CT0085 SDTM 3.1.3 361 total

  8. 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

  9. 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 – 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

  10. 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/--ENDY All Rules are Warnings

  11. 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)

  12. 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

  13. 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 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

  14. 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

More Related