A SAS macro to check SDTM domains against controlled terminology - - PowerPoint PPT Presentation

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A SAS macro to check SDTM domains against controlled terminology - - PowerPoint PPT Presentation

Oct 16, 2023 185 likes •412 views

A SAS macro to check SDTM domains against controlled terminology Christer, living with Parkinsons disease When do we need this? During SAS development of SDTM domains Checking overall compliance to Controlled terminology (CT) for a

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Christer, living with Parkinson’s disease

A SAS macro to check SDTM domains against controlled terminology

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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

&list2. &list1.

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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

  • domains/datasets
  • Studies (libnames)

LIBNAMES = List of Libnames DSETLIST = List of domains/datasets

Index _J Index _I

Input dataset(s) Metadata

Process

Report results

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Extentsion: Multiple domains/datasets

e.g.: &_dset1. = ae &_dset2. = eg &_dset3. = vs etc. &DSETLIST.= ae eg vs …

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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?