1 1 SDTM Validation at Cephalon Delaware Valley CDISC Users Network Meeting May 11, 2009 by Gary Cunningham
SDTM Validation at Cephalon
Jan 30, 2016
SDTM Validation at Cephalon. Delaware Valley CDISC Users Network Meeting May 11, 2009. by Gary Cunningham. SDTM Domain XPT Files. SDTM Supplemental XPT Files. Cephalon Data Flow. Cephalon/CDISC Standard (metadata repository). tabulations. Raw Data Sets SDTM (-). Derived Data Sets - PowerPoint PPT Presentation
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11
SDTM Validation at Cephalon
Delaware Valley CDISC Users Network Meeting
May 11, 2009
by Gary Cunningham
22
Cephalon Data FlowCephalon Data Flow
DerivedData Sets
SDTMand
Analysis
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
RawData Sets
SDTM (-)
Database
Programming
Database
ProgrammingClinical
Programming
Clinical
Programming
tabulationstabulations
analysisanalysis
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
ClinDataClinData
Study-levelMetadata
Study-levelMetadata
33
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
Cephalon SDTM ValidationCephalon SDTM Validation
DerivedData Sets
SDTMand
Analysis
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
RawData Sets
SDTM (-)
Database
Programming
Database
Programming
tabulationstabulations
analysisanalysis
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
ClinDataClinData
Clinical
Programming
Clinical
Programming
Study-levelMetadata
Study-levelMetadata
44
SDTMValidation
SDTMValidation
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
Cephalon SDTM ValidationCephalon SDTM Validation
RawData Sets
SDTM (-)
Database
Programming
Database
Programming
•Primarily focused on checking existing data as opposed to checking for gaps against SDTM model.
•Various data checking / edit checking tools.
•WebSDM
•daily automated batch uploads into WebSDM across all ongoing studies
•WebSDM errors are filtered and reports are sent to Database Programming.
•Primarily focused on checking existing data as opposed to checking for gaps against SDTM model.
•Various data checking / edit checking tools.
•WebSDM
•daily automated batch uploads into WebSDM across all ongoing studies
•WebSDM errors are filtered and reports are sent to Database Programming.
ClinDataClinData
55
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
Cephalon SDTM ValidationCephalon SDTM Validation
DerivedData Sets
SDTMand
Analysis
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
RawData Sets
SDTM (-)
Database
Programming
Database
Programming
tabulationstabulations
analysisanalysis
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
ClinDataClinData
Study-levelMetadata
Study-levelMetadata
Clinical
Programming
Clinical
Programming
66
SDTMValidation
SDTMValidation
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
Cephalon SDTM ValidationCephalon SDTM Validation
DerivedData Sets
SDTMand
Analysis
Study-levelMetadata
Study-levelMetadata
Clinical
Programming
Clinical
Programming
77
SDTMValidation
SDTMValidation
Clinical
Programming
Clinical
Programming
Cephalon SDTM ValidationCephalon SDTM Validation
DerivedData Sets
SDTMand
Analysis
•Primarily focused on validation of single data set against SDTM (and Cephalon) standard during its “build”.
•Each data set build program (via standard macros):
•creates an ERROR and aborts the build if any SDTM (or Cephalon) Required or Expected variable is absent
•creates an ERROR and aborts the build if Cephalon controlled terminology is not used (e.g. --TESTCD, --TEST, --SPID)
•creates an ERROR and aborts the build if any value is truncated as a result of an insufficient length assignment in the metadata
•creates a WARNING if any standard SDTM metadata is being overwritten by study-level custom metadata.
•Other miscellaneous data checking tools.
•Primarily focused on validation of single data set against SDTM (and Cephalon) standard during its “build”.
•Each data set build program (via standard macros):
•creates an ERROR and aborts the build if any SDTM (or Cephalon) Required or Expected variable is absent
•creates an ERROR and aborts the build if Cephalon controlled terminology is not used (e.g. --TESTCD, --TEST, --SPID)
•creates an ERROR and aborts the build if any value is truncated as a result of an insufficient length assignment in the metadata
•creates a WARNING if any standard SDTM metadata is being overwritten by study-level custom metadata.
•Other miscellaneous data checking tools.
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
Study-levelMetadata
Study-levelMetadata
88
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
SDTMValidation
Cephalon SDTM ValidationCephalon SDTM Validation
DerivedData Sets
SDTMand
Analysis
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
RawData Sets
SDTM (-)
Database
Programming
Database
Programming
tabulationstabulations
analysisanalysis
Cephalon/CDISC Standard(metadata repository)
Cephalon/CDISC Standard(metadata repository)
ClinDataClinData
Clinical
Programming
Clinical
Programming
Study-levelMetadata
Study-levelMetadata
99
SDTMValidation
SDTMValidation
Cephalon SDTM ValidationCephalon SDTM Validation
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
Clinical
Programming
Clinical
Programming
1010
SDTMValidation
SDTMValidation
Clinical
Programming
Clinical
Programming
Cephalon SDTM ValidationCephalon SDTM Validation
SDTMSupplemental
XPT Files
SDTMDomain
XPT Files
AnalysisXPT Files
•Primarily focused on validation of SDTM data sets as a whole
•validation of data sets as a submission package against SDTM standard
•includes validation checks across data sets.
•WebSDM
•complete set of SDTM data sets is loaded into WebSDM tool, validation report of structure and consistency errors is generated, and any data set issues are addressed
•done at least two times: prior to database lock and after lock.
•SUPP-- data sets are reattached to parent data sets and programmatically compared to original combined data sets.
•Primarily focused on validation of SDTM data sets as a whole
•validation of data sets as a submission package against SDTM standard
•includes validation checks across data sets.
•WebSDM
•complete set of SDTM data sets is loaded into WebSDM tool, validation report of structure and consistency errors is generated, and any data set issues are addressed
•done at least two times: prior to database lock and after lock.
•SUPP-- data sets are reattached to parent data sets and programmatically compared to original combined data sets.
1111
Other Cephalon SDTM ValidationOther Cephalon SDTM Validation
“Informal” SDTM data set validation:throughout entire data flowPROC FREQ within and across data sets (can be quite powerful!)consistency checks across data setsconsistency checks across studies within the drug projectWebSDM-like checksother miscellaneous checks.
1212
Cephalon SDTM Validation SummaryCephalon SDTM Validation SummaryThree-staged approach to SDTM validation:
Validation of Raw SDTM (-) data sets.Validation of Derived SDTM data sets.Validation of Derived SDTM data sets via submission transport files.
Validation “tools”:Cephalon/CDISC Standard metadata repositoryDerived data set build macrosWebSDMother miscellaneous macroscustom SAS programs.
1313
Comments on ValidationComments on Validation
Three-staged approach to validation helps to ensure that both SDTM and Cephalon standards are followed.Expectation is that the earlier validation will minimize problems later in the data flow process.Validation is needed both within and across SDTM data sets; WebSDM tool provides some valuable checks across data sets that aren’t necessarily possible during individual SDTM data set development.Using the WebSDM tool internally allows Cephalon to proactively address issues that FDA will find with its WebSDM checks.However, WebSDM “errors” should be taken into context as some
WebSDM-defined “errors” may be insignificant or not represent real errors
WebSDM is one tool of many within the validation process and supplements the others, but does not replace them.
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