SAS Clinical Standards Toolkit 1.7.1: What's New

Transcription

1 SAS Clinical Standards Tlkit 1.7.1: What's New Date: 09/30/2016 Prepared by: CST Develpment Team

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3 SAS Clinical Standards Tlkit What's New <CST Glbal Library>\metadata There were updates t metadata files t implement Analysis Results Metadata v1.0 fr Define-XML 2.0: Standards data set Standardlkup data set availabletransfrms.xml Nte: Since this htfix will need t verwrite the existing files in the <Glbal Library>\metadata flder, the custmer may need t update the Glbal Standards Library t include any prir custmizatins and t register the desired default versins f each standard. Framewrk Macrs There were updates t Framewrk macrs related t Validatin. Mre infrmatin in the results data set and the lg was prvided when validatin checks cannt be run because f sublist prblems. cstcheck_clumn cstcheck_clumncmpare cstcheck_clumnvarlist cstcheck_ntcnsistent cstcheck_ntincdelist cstutil_buildcllist cstutil_builddmlist Als, there were minr fixes in: cstutilcheckjava cstutilmanageclumnsize ODM and ODM Updates t ItemData.xsl t fix an issue with Measurement Units nt being imprted crrectly. This als came with an update t the validatin cntrl data sets: validatin_cntrl and validatin_master. Sample ODM XML files and sample data set representatins were changed fr this update as well. 3

4 Small syntax update t sample drivers: extract_dmaindata_all.sas and extract_dmaintemplates_all.sas Dataset-XML Small fixes t datasetxml_read, datasetxml_write and datasetxml_createmap macrs. Cntrlled Terminlgy ADaM Cntrlled Terminlgy was added t the cdisc-ct and cdisc-terminly in CST. SDTM 3.2 Unbalanced qutes and parentheses fixed in reference_clumns metadata. Define-XML 2.0 Templates Added new template: studyanalysisresultmetadata( label='surce Analysis Results Metadata') Added clumns t studydcumentmetadata: displayidentifier char(128) label='analysis Display Identifier' resultidentifier char(128) label='analysis Display Result Identifier' Changed studydcumentmetadata.dctype label: 'Dcument Type (CRF/COMMENT/METHOD)' Changed lengths: studyclumnmetadata.xmldatatype: 8 18 studyclumnmetadata.rigindescriptin: studyvaluemetadata.xmldatatype: 8 18 Deleted studyvaluemetadata.value Added clumn t studyvaluemetadata: rigindescriptin char(1000) label='clumn Origin Descriptin' Since these templates are used t create surce_* data set, these changes will impact the structure f these surce_* datasets Internal mdel data sets: New: analysisdataset analysisdatasets analysisdcumentatin analysisprgrammingcde analysisresultdisplays 4

5 analysisresults analysisvariables analysiswhereclauserefs Updated: in several data sets the lengths were updated XML Schema Validatin Define-XML v2.0 are nw validated against: <CST Glbal Library>\schema-repsitry\cdisc-arm- 1.0\arm1-0-0.xsd This means a change in <CST Glbal Library>\metadata\availabletransfrms.xml and standards.schema The cdisc-arm-1.0 flder was added t: <CST Glbal Library>\schema-repsitry Transfrmatin Stylesheets: Additins and updates t: <CST Glbal Library>\xsl-repsitry\DEFINE-XML\2.0.0 New Display Stylesheet: <CST Glbal Library>\standards\cdisc-definexml \stylesheet\define2-0-0.xsl New Map: <CST Sample Library>\cdisc-definexml \referencexml\define.map Sample Drivers: New: Updated: create_definexml_frm_surce_adam.sas all the ther nes, mstly csmetic. Macr parameters were added, where applicable t implement ARM. Added _cstchecklengths=y t %define_surcetdefine macrcalls Added _cstsurceanalysisresults=sampdata.surce_analysisresults r _csttrganalysisresultds=trgmeta.surce_analysisresults t several macrs t create surce_analysisresults data set Several changes t migrate_crtdds_t_definexml_sdtm.sas and migrate_crtdds_t_definexml_adam.sas 5

6 Updated sample data sets (cdisc-adam-2-1 and cdisc-sdtm-3.1.2): <CST Sample Library>\cdisc-definexml \data <CST Sample Library>\cdisc-definexml \deriveddata <CST Sample Library>\cdisc-definexml \derivedmetadata <CST Sample Library>\cdisc-definexml \derivestudymetadata_crtdds <CST Sample Library>\cdisc-definexml \derivestudymetadata_define <CST Sample Library>\cdisc-definexml \derivestudymetadata_saslib <CST Sample Library>\cdisc-definexml \metadata <CST Sample Library>\cdisc-definexml \results <CST Sample Library>\cdisc-definexml \sascstdemdata\metadata New Macrs: define_surceanalysisresults.sas defineutil_splitwhereclause.sas defineutil_validatelengths.sas defineutil_validatewhereclause.sas Detailed macr changes: define_createsrcmetafrmdefine.sas Added _csttrganalysisresultds= parameter The macr will ptinally - create the Analysis Results Metadata data set as specified in the _csttrganalysisresultds parameter define_createsrcmetafrmsaslib.sas Added _csttrganalysisresultds= parameter The macr will ptinally - create the Analysis Results Metadata data set (0 bservatins) as specified in the _csttrganalysisresultds parameter cstutilgetncimetadata.sas Minr changes related t _cstdebug cstutilmigratecrtdds2define.sas 6

7 Added parameters: _cstsrctype= and _cststandardversin Will nw create Analysis Results Metadata data set when _cstsrctype=analysisresult The resulting data set is very much an initial surce dataset, since the existing surce metadata dataset that was in CST (C:\cstSampleLibrary\cdisc-adam \sascstdemdata\metadata\analysis_results.sas7bdat) is very insufficient) define_surcetdefine.sas Added parameters: _cstsurceanalysisresults= and _cstchecklengths=n Macr calls t %define_surce<xxxx> macrs updated with _cstchecklengths and ther new applicable parameters. define_surcestudy.sas Added parameter: _cstchecklengths=n Changed NAME and DESCRIPTION values in utput MetaDataVersin data set define_surcetables.sas Added parameter: _cstchecklengths=n define_surceclumns.sas Added parameter: _cstchecklengths=n define_surcecdelists.sas Added parameters: _cstsurcetables= and _cstchecklengths=n define_surcevalues.sas Added parameters: _cstsurcetables=, _cstsurceclumns and _cstchecklengths=n Added call t %defineutil_validatewhereclause macr Replaced cde with call t %defineutil_splitwhereclause macr define_surcedcuments.sas Added parameters: _cstsurcetables=, _cstsurceclumns, _cstsurceanalysisresults and _cstchecklengths=n Substantial changes t the macr. surce_dcuments.doctype has new values: "SUPPDOC", "DISPLAY", "RESULTDOC", "RESULTCODE" Better validatin f surce_dcuments.pdfpagerefs SAS and all ther SAS Institute Inc. prduct r service names are registered trademarks r trademarks f SAS Institute Inc. in the USA and ther cuntries. indicates USA registratin. Other brand and prduct names are trademarks f their respective cmpanies. Cpyright 2016 SAS Institute Inc., Cary, NC, USA. All rights reserved. 7