WG: Optimizing the Use of Data Standards

Wednesday Webinar28th Feb, 2018

SDTM and ADaM Implementation FAQ Project Update

PresentedbyProjectLead:BhavinBusa

Lookingforvolunteertoco-lead!

SDTM/ADaM Implementation FAQ

• TheStandardsImplementationNuancessessionsattheMar2016NorthAmericaCSSandJun2016EUCSSsurfacedvariouscommonchallengesamongstSDTMandADaMimplementersandconsumers

• Industryinneedofaforumandsubsequentknowledgebase(FAQ)toaddressthesechallenges

SDTM/ADaM Implementation FAQ

• AworkinggroupwasformedtocollaboratewithCDISC,FDA,andindustryinJune2016.• Participants:

• FDA&CDISC• SDTM/ADaMImplementationSMEs• Industry

• Projectteammeetingandcollaborationonceevery2weeks(Tuesday@10:00AMEST)

• 77membersacross36organizations(FDA,CDISC,Sponsorcompanies,andvendors)

Implementers&Consumers

PhUSEProjectTeam

PhUSEWiki

Collaboration Tools

• Working with PhUSE Wiki (public)http://www.phusewiki.org/wiki/index.php?title=SDTM_ADaM_Implementation_FAQ

• Walk through project teamwork site (project team members only) https://phuse.teamworkpm.net/projects/157138/overview

• Submitting Questions (public)http://www.phuse.eu/wiki-feedback

• FAQ Database (public)http://www.phusewiki.org/wiki/index.php?title=SDTM_FAQ_Team_Responses

Examples of the FAQ - Published

• WhatarebestpracticesforcreatingCTfor/representingquestionnaireresponses?

• Whatisthegeneralrecommendation/approachforgenerating/submittingcustomdomains(e.g.non-standardCDISCSDTMdomains)toregulatoryagencies?

• Doesthelegacydatainnon-CDISCformatneedtobeconvertedtoSDTMforallstudiesthatarepartoftheFDAorPMDAsubmissions? Ifasponsorhasonepivotalstudyinnon-CDISCandtheotherpivotalstudyinCDISC,doIneedtoconvertbothtoCDISCformatbeforesubmission?

Examples of the FAQ - Published

• WillJumpStart(DataFit)servicesbeavailableforpharmaclientsbeforesubmission?WhatkindofchecksareincludedinJumpStart?

• WhenwillCDISC(SDTM/ADaM)datastandardsbemandatoryfordatasubmissionandhowdoesthisdifferfromforeachregulatoryagency?

• WhyareScreenFailuresandNotAssignednotrepresentedinTA?

• HowshouldasubjectthatisincorrectlydosedberepresentedinSE(i.e.asubjectisrandomizedtoDrugA,butreceivesDrugB)?Unplannedelement?

• HowtodefineanunplannedElementinSE?Example:unexpectedwashout

Examples of the FAQ – Work in Progress• WhatistherequirementforClinicalSiteDataandSubject-levelDataListings

forFDACDER’sInspectionProcess(alsocalledBIMOsubmissionorOSIPre-NDArequest)?

• Whatgoesinthe“misc”folderwithanm5eCTDfolderstructure?Forexample,alookupfilecontainingSMQassignment.

• DoestheSponsorneedtosubmitSASCodes?Doesithavetobeexecutable?Isthereanyguidanceonthat?

US CSS 2018 (March 5 – March 6)

• 2Breakoutsessions:March5th andMarch6th

– Agenda:https://www.phuse.eu/css18-agenda

• QuestionsandTopicsofdiscussionduringthebreakoutsessions:– Integration(ISSandISE)– integratedSDTMvs.integratedADaM– SubmissionofAnalysisResultsMetadata(ARM)– FDAandPMDAsubmissionpackage– NextversionofIG– Triallevellookupconceptandmethods

ProjectLeadContactInformation:

BhavinBusa(VitaDataSciences):bbusa@vitadatasciences.com