Optimizing the Use of Data Standards CSS Summary PhUSE Webinar 26 April 2017

Co-Leads: Susan Kenny (Maximum Likelihood)

Jane Lozano (Eli Lilly)

BestPrac*cesforDataCollec*onInstruc*ons

•  Thisprojectteam,inpartnershipwithCDISC,willcreateawhitepaperdocumen9ngchallengesandgapswiththeCDASHCRFcomple9onaswellasrecommenda9onsforafutureversionofCDASH.–  StandardAnalysisandCodeSharingWGleadsprovidedanoverviewoftheir

currentworkandthelimita9onsencounteredwhenworkingtocompilestandardanalysisandre-usablescriptsduetothevariabilityinhowdataiscollected

–  Addi9onaldiscussionsaroundthisprojectfollowedatboththeCSSandCDISCIntraChangewhichhighlightedboththemanychallengeswithstandardizingcollec9onprac9cesandalsotheopportuni9es/benefitsofdoingso.

ProjectLead:ToddBazin-Biogen

BestPrac*cesforMetadataDocumenta*on(Define-XMLdocumentvs.reviewer’sguide)

•  Thisprojectisaimedatlookingatuseofthereviewer'sguideinconjunc9onwiththeDefine-XMLdocument.Theteamplansondeliveringawhitepaperthisyear.–  Wedidnotmeetatthisyear’sCSS,butdidfindsomeaddi9onalfolks

interestedinjoiningthegroup.–  SandywillbesePngupmee9ngstogetbacktoworkonthewhitepaper

withagoaloffinishingthepaperthisyear.–  Theposter“Sor9ngOutthePaperwork”wonanawardattheCSS

ProjectLead:SandyVanPeltNguyen-Pfizer

DataReviewer’sGuideinXML

•  ThisprojectteamwilldeveloptheDataReviewer'sGuide(i.e.,SDRGandADRG)inanXMLformatforregulatorysubmissions.–  ProvidedDRGinXMLoverviewtoaWendeestoensureawareness,obtain

interestanddiscussthepossibili9esoftheproject.–  ConductedanFAQsessioninordertoobtainfeedbackfromimplementers

acrossmul9pleorganiza9ons.–  ExplainedtheimportanceofamachinereadableDRG.Furtherextrapolated

thenecessityofcross-documentinteroperability(e.g.,Define-XMLdocument).

–  Recruitmentoftechnicalexpertsintheareaofstylesheet,schemaandXMLdevelopment.

ProjectLead:MikeHamidi-Merck

Define-XMLv2.0Comple*onGuidelines&StylesheetRecommenda*ons

•  Deliverable: Completion Guidelines document, focusing on best practices for content and granularity. –  Examples of how to populate challenging metadata items under a few relevant scenarios

•  Estimated completion for Phase 1: 3Q2017 –  ~17 active members from Pharma/Biotech Sponsors, Consulting companies, CDISC Teams and FDA

•  In Scope: –  Phase 1: SDTM/ADaM/SEND Phase 2: ARM –  Coordination with CDISC Teams (Define-XML, MSG, SDTMIG, SENDIG, ADaMIG) and other PhUSE Teams

•  Securing appropriate CDISC teams representation to support/lead CG discussions •  Avoiding redundancy with other teams deliverables, specially Define-XML and MSG

•  Out of Scope: –  A comprehensive metadata definition for any given study –  A data model for representing metadata –  Operational implementation guidelines –  Technical guidance/reference on how to develop software to create a Define-XML document

Comple*onGuidelines(CG)ProjectLeads:MarcelinaHungria-DIcoreGroupPrafullaGirase-Biogen

Define-XMLv2.0Comple*onGuidelines&StylesheetRecommenda*ons

•  DeliverablesoftheStylesheetRecommenda9onsprojectteam:Phase1:DevelopmentofaDefine-XMLv2.xstylesheetforregulatorysubmissions–  Phase1scopeinaddi9ontothestylesheetdevelopment:

•  Documenta9onofthestylesheet–explana9ononhowparametersandstylesheetscanbeu9lized,processforHTMLcrea9on,andthelistoftestedbrowsers.

•  TestXMLs–XMLfileswhichimplementdifferentaspectsoftheDefine-XMLv2.0standardtotestastylesheetfunc9onality.

Phase2:Demonstrateotherusesofastylesheet

StylesheetProjectLeads:DmitryKolosov-PAREXELLexJansen-SAS

LegacyDataConversionPlan&Report ProjectLead:JaneLozano–EliLilly

•  Thisprojectteamisworkingonastandardizedapproachtothedevelopmentofasingledocumenttoaddressconversionsfromnon-standardizeddata(i.e.legacy)tostandardizeddata(SEND,SDTM,ADAM).–  ThescopewasagreedattheCSSinthatthecSDRGandADRGwillcontaina

newsec9onfortheLegacyDataConversionPlan&Report–  Thedefini9onoflegacyincludesdatathatwascreatedinSDTMv1.1/IG

3.1.1–  Metwiththenonclinicalgroupanddeterminedthatthedefini9onoflegacy

isnotthesameforthem•  Nonclinicaltoprovidethisprojectteamtheirdefini9on

–  Sub-groupsformedtoupdatetheexis9ngComple9onGuidelinesandExampleDocuments

SDTMADaMImplementa*onFAQ

•  Thisprojectfocusesonunderstandingstandardsimplementa9onnuancesthatexistacrossavailableSDTMandADaMversions.–  Progressmadebythesub-groups:

•  Teamcompletedreviewofques9onsanddraeedresponseswithin4ofthesub-groups•  Teamiscurrentlyrecrui9ngleadsforthefollowingsub-groups:

–  Therapeu9cAreaSpecific–  LegacySDTMMapping

–  ProjectwillhavesessionsatthePhUSEEUCSSinJune.–  Formatexiststosubmitques9ons,buttechnologyneedstobeimprovedto

makethismorevisibleandhaveaGoogleform9edtotheWiki.–  Teamisreadytopublishthecurrentques9onsandanswersontheWikiaeer

CSSSteeringCommiWeereview.

ProjectLeads:BhavinBhusa–So[worldLifeSciencesMatBryant–inVen*vHealthClinical

StudyDataStandardiza*onPlan

•  ThisprojectteamhasdevelopedthedeliverablesthatsponsorscanusenowandareavailableontheWiki.–  MetwithCBERtodiscusstheirversionoftheSDSP

•  TheteamagreedtoaddanappendixtotheSDSP

–  Comple9onGuidelinesandExampleDocumentswillbeupdatedtoreflectaCBERexample

–  FDAprovidedcommentsfromtheFRNo9ceforIntenttoReview•  Thetemplatewasupdatedbasedonthecomments•  Thereareaddi9onalcommentsthatFDAisreviewing

–  ThemostcurrentversionofthetemplateisontheWiki(withtheUpdated28March2017appendageinthename)•  Theoriginaltemplateiss9llontheWiki

ProjectLead:JaneLozano–EliLilly

PossibleNewProjects Ø  PMDA/FDASubmissions

Ø  PossiblewhitepaperondifferencesbetweenFDAandPMDAinregardstosubmissions.Ø  PhUSEislookingattheJPMAUserAideforADRG

Ø WhendataisintegratedaversionoftheSDRGorADRGiscreated,buttheyaresingle-studyfocusedandnotmul9ple-studyfocusedØ  LegacyDataConversionPlan&Reportcouldbeincludedifstudydatais

up-versionedwithinanintegra9on

Ø  Implemen9ngtheWHODrugB3Format-BestPrac9cesforIntegratedDatabases

HowtoFindOutMore&GetInvolved Ø  PhUSEWebsite:

Ø  hWp://www.phuse.eu/

Ø  Projectac9vityanddeliverablesareonthePhUSEWiki:Ø Op9mizingtheUseofDataStandards

Ø Ques9ons?ContactUs!Ø  SusanKenny–susankenny@maxlikelihood.comØ  JaneLozano-j.a.Lozano@lilly.com