Transcript presentation

A SAS macro to check SDTM
domains against controlled
terminology
Christer, living with Parkinson’s disease
When do we need this?
During SAS development of SDTM domains
Checking overall compliance to Controlled terminology (CT) for a study.
Checking CT of one domain across multiple studies e.g. for pooling.
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Process Flow: The metadata
Input
dataset(s)
Metadata
Process
Report results
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Controlled terminology (CDISC)
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CDISC SDTM 3.1.2
Validation Rules for controlled terminology (CT)
…
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Derive variables that have to comply to CT
Input
dataset(s)
Metadata
Process
Report results
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Intersection of two lists of values
&list1.
&list2.
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Join metadata information (and create instructions)
Input
dataset(s)
Metadata
Process
Report results
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Build values list
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Creating a list iteratively
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Input
dataset(s)
Metadata
Process
Report results
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Creating the violations dataset
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Violations dataset: One OBS per violation
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Extension: Multiple studies and multiple domains
Extension: Multiple
Input
dataset(s)
Metadata
• domains/datasets
• Studies (libnames)
LIBNAMES = Index _J
List of Libnames
Process
Index _I
DSETLIST =
List of domains/datasets
Report results
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Extentsion: Multiple domains/datasets
&DSETLIST.= ae eg vs …
e.g.:
&_dset1. = ae
&_dset2. = eg
&_dset3. = vs
etc.
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Extension: Multiple libnames
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Reporting and tabulation
Input
dataset(s)
Metadata
Process
Report results
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Xml-Output (in Excel)
http://support.sas.com/rnd/base/ods/odsmarkup/excelxp_help.html
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XML Output
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Conclusion
Can be used within SAS programs
ADaM or SDTM
Multiple studies can be checked simultaneously
Users can control and modify input metadata (sponsor or study
specific codelists)
Scope is addressed via macro parameters
•
All domains of current study
•
Specific domains across various studies etc.
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Questions?
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