simplifying sas clinical standards toolkit Ð whereÕs the ...odm 1.3.0, odm 1.3.1, sdtm 3.1.1, sdtm...

© 2012 SAS Institute Inc. All rights reserved S97004.0912 F r a m e wo r k S t a nd a r d R e f e r e n c e This poster represents CDISC SDTM 3.1.2. Other CDISC models in SAS Clinical Standards Toolkit 1.5 include ADaM 2.1, CRT-DDS 1.0, ODM 1.3.0, ODM 1.3.1, SDTM 3.1.1, SDTM 3.1.3, and SEND 3.0 Framework Macros SAS macros specic to managing framework and standard metadata. Used to initiate new standards and contains cross-standard validation macros. Framework Metadata Contains metadata specic to the management of cross-standard metadata. Simplifying SAS ® Clinical Standards Toolkit – Where’s the Easy Button? Gene Lightfoot, SAS, Cary, North Carolina, US Standard Metadata contains information about the standard. This includes table, column and validation metadata. The “gold” standard used to verify cross-study metadata within a standard. Tables include reference_tables, reference_columns, validation_master, etc. Standard Macros Contains macros designed to handle standard specic implementation across one or more studies. Study Metadata Source_tables.sas7bdat Source_columns.sas7bdat Validation_control.sas7bdat Framework Study Driver Programs SAS supplied programs designed to submit processes, run validations, and create output. Study Data Comprised of SDTM 3.1.2 domains containing study data. Once SAS Clinical Standards Toolkit has been setup by the customer, in this case SDTM, they have the choices of running SDTM validations and DEFINE.xml creation against their study data. This is accomplished by submitting simple “driver” programs supplied with the product or as jobs with SAS Clinical Data Integration. CREATE_CRTDDS_DEFINE CREATE_CRTDDS_DEFINE_PDF CST_METADATAREPORT VALIDATE_DATA CST_REPORT SAS Clinical Standards Toolkit 1.5 is designed to run stand- alone with Base SAS. The user interface is SAS Clinical Data Integration. SAS Clinical Standards Toolkit will also run on SAS Drug Development 4.1 and the current release of JMP ® Clinical. This poster was created during development. CDISC models supplied with the product are subject to change. N e w S t a n d a r d C u s t o m i z e d S t a n d a r d N e w S t u d y Customer supplied SAS Formats MedDRA NCI Controlled Terminology SASReferences Framework SASReferences The “glue” that holds all of this together. The SASReferences data set supplies information and metadata. This information can be user supplied or derived from standard metadata. Standard Dictionaries Study S t u d y R e f e r e n c e Controlled Terminology Dictionaries Comprised of Controlled Terminology as supplied by National Cancer Institute. Provided and implemented as a unique standard. MedDRA customer supplied and not provided. Any customer supplied controlled terminology or coding dictionaries. Driver Programs C o n t r o l l e d T e r m i n o l o g y / D i c t i o n a r i e s

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© 2012 SAS Institute Inc. All rights reserved S97004.0912

Frame

work

Standard Reference

This poster represents CDISC SDTM 3.1.2. Other CDISC models in SAS Clinical Standards Toolkit 1.5 include ADaM 2.1, CRT-DDS 1.0, ODM 1.3.0, ODM 1.3.1, SDTM 3.1.1, SDTM 3.1.3, and SEND 3.0

Framework MacrosSAS macros speci!c to managing framework and standard metadata. Used to initiate new standards and contains cross-standard validation macros.

Framework MetadataContains metadata speci!c to the management of cross-standard metadata.

Simplifying SAS® Clinical Standards Toolkit – Where’s the Easy Button?Gene Lightfoot, SAS, Cary, North Carolina, US

Standard Metadatacontains information about the standard. This includes table, column and validation metadata. The “gold” standard used to verify cross-study metadata within a standard. Tables include reference_tables, reference_columns, validation_master, etc.

Standard MacrosContains macros designed to handle standard speci!c implementation across one or more studies.

Study MetadataSource_tables.sas7bdatSource_columns.sas7bdat Validation_control.sas7bdat

Framework

Study Driver ProgramsSAS supplied programs designed to submit processes, run validations, and create output.

Study DataComprised of SDTM 3.1.2 domains containing study data.

Once SAS Clinical Standards Toolkit has been setup by the customer, in this case SDTM, they have the choices of running SDTM validations and DEFINE.xml creation against their study data.

This is accomplished by submitting simple “driver” programs supplied with the product or as jobs with SAS Clinical Data Integration.

CREATE_CRTDDS_DEFINE

CREATE_CRTDDS_DEFINE_PDF

CST_METADATAREPORT

VALIDATE_DATA

CST_REPORT

SAS Clinical Standards Toolkit 1.5 is designed to run stand-alone with Base SAS. The user interface is SAS Clinical Data Integration. SAS Clinical Standards Toolkit will also run on SAS Drug Development 4.1 and the current release of JMP® Clinical.

This poster was created during development. CDISC models supplied with the product are subject to change.

New Sta

nd

ard

Customized

Stand

ard

New Study

Customer supplied SAS Formats

MedDRA

NCI ControlledTerminology

SASReferencesFramework

SASReferences The “glue” that holds all of this together. The SASReferences data set supplies information and metadata. This information can be user supplied or derived from standard metadata.

Standard

Dictionaries Study

Stu

dy R

efere

nce

Controlled Terminology DictionariesComprised of Controlled Terminology as supplied by National Cancer Institute. Provided and implemented as a unique standard.MedDRA customer supplied and not provided. Any customer supplied controlled terminology or coding dictionaries.

DriverPrograms

Controlled Terminology/Dictionaries