Study Data Standards in eCTD: What You Need to Know …

1 1 Study Data Standards in ectd : What You Need to Know about the New technical rejection CriteriaRon Fitzmartin, PhD, MBAS enior AdvisorOffice of Business InformaticsVirginia HussongDirector of DDMSSO ffice of Business InformaticsLisa LinSenior Regulatory AnalystOffice of Business InformaticsCrystal AllardSpecial Assistant to the DirectorOffice of Computational ScienceCenter for Drug Evaluation and ResearchFood and Drug AdministrationOctober 12, 2016 CDER SBIA Webinar Series2 The views and opinions presented here represent those of the speakers and should not be considered to represent advice or guidance on behalf of the Food and Drug Administration.

2 FDA DISCLAIMER3 GUIDANCE AND POLICY4 Study data Standards describe a standard way to exchange clinical and nonclinical research data between computer systems. SDTM (including Therapeutic Areas) the full list of Study data Standards , see the Data Standards Catalog at DATA STANDARDS45 When Will Study Data Standards be Required?Studies starting AFTER required dateMUST use the Standards in the Data Standards Catalog (NDAs, ANDAs, BLAs)Published December 17, 2014 Required for NDAs, BLAs, ANDAsDecember 17,2016 Compliance Required for CommercialINDsDecember 17, Data Standards Will be Required?December 2016 FDA Data Standards CatalogStudy , ADaM, SEND, the full list of Study data Standards , see the Data Standards Catalog at To GuideStudy Data Standardization PlanAnalysis Data Reviewer s GuideStudy Data Reviewer s GuideSDTM DomainsExchange FormatsFile TransportSDTM General ConsiderationsSEND DomainADaM Domain SpecsControlled TerminologiesTherapeutic AreasData Validation and TraceabilityElect Sub formatVersion to be posted October 2016 Will Data Study Standards be Required?

3 88 Yes!eStudyGuidancerequires the electronic submission of NDAs, BLAs, ANDAs, INDsin standardized formatCan FDA RTF / RTR Submissions for Non-conformance? 9 BUT FDA DOES NOT WISH TO RTF / RTR FOR SO1010 FDA will implementa process for rejection of submissions that do not conform to the required Study data Standards 11 Data RepositoriesAnalytic Data QualityValidationStudy Data Conformance ValidationStudy Data Standards ValidationDataDataDataSponsor NDAs, BLAs, INDs, ANDAs12 technical rejection of the SubmissionData RepositoriesReviewersDataSponsor NDAs, BLAs, INDs, ANDAsDataDataDo Study data conformto required Standards ?

4 NOAcknowledgement sent via ESG on unsuccessfulvalidation and processingAcknowledgement sent via ESG on successfulvalidation and processingYESEDRA nalyticToolsConformance How will it work?Data Quality dataset (DM) and the must be submitted in Module 4 for nonclinical data; DM dataset, the Subject level analysis dataset (ADSL) and must be submitted in Module 5 for clinical dataTrial Summary (TS) dataset must be presented for each Study in Module 4 or 5 Correct STF file-tags must be used for all standardized datasets Data-tabulations-dataset-sdtm Data-tabulations-dataset-sendFor each Study , no more than one dataset of the same type should be submitted as new Analysis-dataset-adamHighMediumMediumHig heCTDData Validation criteria and Severity14SO WHICH IS BETTER?

5 technical RejectionYay! Oh No RTF!1576%of Study data submitted within all NDA submissions are in standardized SDTM format**FY2016 **Source: Office of Business Informatics, CDER -One or more explicitly stated SDTM studies (or Study data structure that resembled SDTM).85%of Study datasubmitted in support of NEWNDAs are in standardized SDTM format**Standardized Study DataWhat are the Current Metrics?16 technical CONFORMANCE GUIDE 17In Study Data technical Conformance Guide (TCG) SDTM Domain Specifications Trial Design Model (TDM) -All TDM datasets should be included in the submissions and Trial Summary (TS) dataset will be used to determine the time of Study start.

6 TS should include TSPARMCD = SSTDTCand TSVAL= yyyy-mm-dd (ISO8601)TRIAL DESIGN DOMAIN18 SEND Domain Specification Trial Design (TDM) All TD datastesshould be included in the submissions and TS dataset will be used to determine the time of Study start. TS should include TSPARMCD = STSTDTC and TSVAL= yyyy-mm-dd (ISO8601)TRIAL DESIGN DOMAIN19 Legacy data submissions TS should be submitted and should include TSPARMCD = SSTDTC or STSTDTC(non-clinical data) and TSVAL= yyyy-mm-dd (ISO8601)TRIAL DESIGN DOMAIN20 TRIAL DESIGN DOMAIN Example TS for clinical data TS for non-clinical data21 SUMMARY & KEY POINTS Starting 12/18/2016.

7 ** All ** clinical and nonclinical trials, regardless of Study type, must use the Standards in the FDA Data Catalog FDA will validate submissions upon receipt and will assess conformance to required Study data Standards A technical rejection notice will be sent if the submission fails validation technical Conformance is key document to help you get it right FDA will provide 30 days notice prior to the validation criteria being effective22 INFORMATION FOR INDUSTRY Click for: Data Standards Catalog Study Data technical Conformance Guide PDF of today s slides Contact the CDER eDataTeam for assistance related to Study data and about material presented during this Q&A begins shortly type in your questions for Evaluation and Certificate