SDTM and ADaM Implementation FAQ Project Update · 2018. 3. 2. · the Mar 2016 North America CSS...
9
WG: Optimizing the Use of Data Standards Wednesday Webinar 28 th Feb, 2018 SDTM and ADaM Implementation FAQ Project Update Presented by Project Lead: Bhavin Busa Looking for volunteer to co-lead!
Transcript of SDTM and ADaM Implementation FAQ Project Update · 2018. 3. 2. · the Mar 2016 North America CSS...
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
