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NJ CDISC User GroupSeptember 19, 2013
Updates on CDISC Standards Validation
TopicsCDISC standards validation initiativeFDA update on SEND checksOpenCDISC v1.4.1 releaseOpenCDISC plans
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CDISC validation projectsPast
ADaM validation checks Define.xml tool (schema only) CAB project
Current plan (CDISC Intrachange 2013)Each CDISC development team will create a
comprehensive list of business rules as a supplement to their standards
Rationale Standards developers are the best experts in
defining standards compliance requirements3
CDISC ADaM Validation ChecksFirst v1.0 was introduced in 2010-10Current v1.2 was released on 2012-07v1.2 includes 244 checks based on ADaM IG
textADSL and BDS data onlyToday the team is planning 2 iterations
update existing checks and create new checks for ADAE, ADTTE data
update checks after a new release of ADaM IG
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Define.xmlXML Schema Validation for Define.xml v1.0,
2009-11Validator for Define.xml schema, 2009-12Define.xml v2.0 includes many business rules
embedded in standard specifications Today the team is working on detailed list of
validation rules Executable specification will be published as
Schematron
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SDTM and SENDCAB/VP project, 2010
Evaluated compliance rules for SDTM/define.xml
Reviewed checks across different vendorsCurrent plan:
Create comprehensive list of business rules as a supplement to new standards. E.g., SDTM v3.1.5, TA standards, etc.
Challenges: Extra resources are needed Synchronization across teams Exact project scope and format are still under
discussion6
FDA’s validation rules for SEND datahttp://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM367129.xlsx
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FDA Rule number MESSAGE DESCRIPTION DOMAINS SEVERITY
NONCLIN-0006
Invalid variable name. Variable names in the domain datasets should be compliant with the SEND standard
Only variable names listed in the SENDIG Version 3.0 should be used in a domain dataset.
ALL Error
NONCLIN-0007
Invalid format for TEDUR. The variable value values must conform to the ISO 8601 international standard
The variable values for all timing variables must conform to the ISO 8601 international standard
TE Error
NONCLIN-0008
Invalid format for RFSTDTC. The variable value values must conform to the ISO 8601 international standard
The variable values for all timing variables must conform to the ISO 8601 international standard
DM Error
NONCLIN-0009
Invalid format for RFENDTC. The variable value values must conform to the ISO 8601 international standard
The variable values for all timing variables must conform to the ISO 8601 international standard
DM Error
Off-Topic: FDA’s Position StatementStudy Data Standards for Regulatory Submissions FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. The submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product. The Prescription Drug User Fee Act (PDUFA V)[2] Performance Goals state that FDA will develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in applications. In the near future, FDA will publish guidance that will require study data in conformance to CDISC standards.[3] FDA envisions a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care. To this end, FDA will continue to research and evaluate, with its stakeholders, potential new approaches to current and emerging data standards. FDA does not foresee the replacement of CDISC standards for study data and will not implement new approaches without public input on the cost and utility of those approaches. September 13, 2013http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm368613.htm8
OpenCDISC v1.4.1 release, 2013-09-12
Bug fixes, enhancements, but no global changes
Support for QS TerminologyCDISC CT checks for extensible codelists are
Informational and independent from user’s codelists in Define.xml
SDTM 3.1.1 with all applicable checksSimplified, consistent and concise error
messages and rule descriptionsExcel report includes versions of Validator,
CT, and MedDRAEnhancement to check definition syntax
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SDTM TerminologyNew CDISC Control Terminology checks
based on CT rather than on outdated SDTM IG assignmentsPKUNIT instead of UNIT in PC and PP domainsPKPARM, SCTEST, etc.QS Terminology (CT0100-CT0255 checks)
CT 1:1 consistency checks for paired variables TSPARM/TSPARMCD, EGTEST/EGTESTCD,
etc. Terminology checks on non-extensible
codelists were changed to Errors CT0001 (ACN), CT0002 (AESEV),
CT0030 (RELTYPE), CT0059 (NY), etc.
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Examples of SDTM checks “tuning”Rule SD0006 (“No baseline results”) was
modified to exclude NOTASSGN subjects Rules SD0026 and SD0029 (“units are required”)
were modified to exclude PH, SPGRAV and all Antibody lab tests
Rule SD0037 (data vs. user’s codelist) was modified to exclude EGORRES variable
Rule SD0069 (“No Disposition record for subject”) was modified to exclude SCRNFAIL and NOTASSGH subjects
Rule SD1037 (“Missing value for --TOX, when --TOXGR is populated”) was modified to ignore records with TOXGR=0 11
SEND specificFixed incorrect variable labels and order
of variables in domainsSeveral Check ID replacement for
consistency with SDTM checks CT1003-> CT0088, CT1004->CT0089, etc.
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ADaMChecks compliant with ADaM Validation
Checks 1.2Change all consistency rules to only run
when primary variables are populatedRemove AD1002 - Expected variable is not
present within dataset. This is not a real rule. It was copied from SDTM logic
Changes to improve label validation (AD0018)
Addition of other rules interpreted from IG, which were not released by CDISC team
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OpenCDISC v2.0Date of release is planned for 2013Q4Support for Define.xml v2.0Metadata drivenSpecifications based on Define.xml v2.0
formatValidation organized by functional area. E.g.,
- SDTM Compliance- Control Terminology- Metadata- Regulatory Specific- Data Quality
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Example of metadata driven checksSD1117 “Duplicate records” in Findings
domainThe “generic” check uses 10 Key Variables
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USUBJIDESTCD --CAT--SCAT--METHOD--SPEC--DRVFL--EVALVISITNUM --TPTNUM
Key variables as defined in SDTM IG
IE STUYID, USUBJID, IETESTCD
LBSTUDYID, LBTESTCD, LBSPEC, VISITNUM, LBTPTREF, LBTPTNUM
QSSTUDYID, USUBJID, QSCAT, QSTESTCD, VISITNUM, QSTPTREF, QSTPTNUM
DA STUDYID, USUBJID, DATESTCD, DADTC
FASTUDYID, USUBJID, FAOBJ, VISITNUM, DATPTREF, FATPTNUM
TUSTUDYID, USUBJID, TULINKID, TUTESTCD, TUSTRESC, (TULOC, TULAT, TUDIR, TUMETHOD), TUEVAL, VISITNUM
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SDTM IG: “Note that the key variables shown in this table are examples only. A sponsor‘s actual key structure may be different.”
Combined Key variables
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STUDYIDUSUBJIDPOOLID--LNKID--SPID--TESTCD--OBJ--ORRES--CAT--SPEC--LOC--DIR--LAT--METHOD*--DRVFL*--ANTREGVISITNUM--DTC--ENDTC--TPTREF--TPTNUM
* added by OpenCDISC as common cases in actual study data
The check implementation options
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Generic check with 20 key variables?Separate check for each domain?
v.2.0 approachTake domain key variables from Standard
metadataIf define.xml is available, then utilize key
variables provided in Study metadataCompare Standard and Study key variables
OpenCDISC NetworkMore direct involvement in OpenCDISC
project development processBeta testingRequirements inputAdditional resources for new projects
Better supportFace-to-face meetings with usersWebinarsTraining and sharing users experience
First meeting is before CDISC Interchange 2013
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References CDISC ADaM resources
http://www.cdisc.org/adam
CDISC define.xml resourceshttp://www.cdisc.org/define-xml
FDA Study Data Standards Resourceshttp://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
OpenCDISC http://www.opencdisc.org
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Questions/Feedback
Sergiy Sirichenko [email protected]
Max Kanevsky [email protected]
Mike DiGiantomasso [email protected]
http://www.opencdisc.org/
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