2Agenda: Things Old, Things New and Things to Come CDISC Standards and MeFoundational StandardsTherapeutic Area StandardsSHARE MetadataTools and ProcessesCDISC Standards and You
3The CDISC Mission Wayne’s Mission The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.Wayne’s MissionData Standards to Improve Clinical Research
4What is a CDISC Data Standard? A CDISC data standard is any product (including specifications, user guides, implementation guides, models or schemas) provided by CDISC that describes representation of clinical* research data and has been properly developed, vetted and approved through the CDISC process. * And non-clinical
52014 Technical Plan – Q3 Update Changes to Roadmap include adjustment of timelines, new Vaccine Data IG project, new CT Registry project, multiple SHARE projects, removal of healthcare link.
6Progress Update – Foundational Stds Products Released in 2014:Dataset-XML v1 FinalSDTMIG 3.3 Batch 1 (4 draft domains)ADaM Occurrence Data Structure v1 DraftADaM IG v1.1 DraftQuarterly Terminology and Periodic QS SupplementsUpdated COP-001 and Process DocsADaM Results Metadata SpecificationUpcoming New Drafts for Comment:Pharmacogenomics IG v1 DraftSEND v3.1 DraftSDTM Batch 2 (Disease Milestones, Domains)
7Governing the SDTM Product Family Bridging the Silos:Governing the SDTM Product FamilyStudy Data Tabulation Model (SDTM)SDTMIGHuman ClinicalSDTMIG-MDMedical DevicesSEND IGNon-ClinicalSDTMIG-PGxPharmacogenomicsSDTMIG-APAssociated PersonsCDISC Therapeutic Area User GuidesSDTMIG QSSupplements
12CDISC Technical Roadmap - 2014 Foundational StandardsData Exchange LayerXML, RDF, …PROTOCOLSDS/SDTM ProductsCDASHSemantic LayerBRIDG/Terminologies/SHARESENDADAMFunctional LayerSDTM, SEND, ADaM, CDASH …OthersXML TechnologiesSemanticsImplementation LayerTherapeutic Area Guides,Questionnaire GuidesHealthcare Interoperability KitsControlled TerminologyBRIDGCDISC SHARE R R R3Therapeutic Areas (CFAST)Track 1 ProjectsChanges to the Roadmap include an initial timeline orientation (with Release of SHARE R1), removal of Glossary (not active, and no transition planned to SHARE), and removal of separate Healthcare Interoperability tracks.Track 2 ProjectsTrack 3 ProjectsHealth Care InteroperabilityThe Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE
13What is SHARE?SHARE is a standards metadata repository for authoring, governing, and publishing CDISC standardsSHARE combinesSOA Semantics ManagerISO Metadata ModelCDISC Standards ModelCDISC Foundational and TA StandardsControlled TerminologyExports to ODM, Define-XML and RDFEnables the development of a consistent, end-to-end standards model13
14User Perspectives of SHARE iSHARE(SHARE Interactive)eSHARE(SHARE Exports)Standards Development& GovernanceAccessing Published Standardsin a Machine-Readable Format
17Opportunities for Participation in CDISC and CFAST Projects Read and provide comments on CDISC standards posted for reviewVolunteer for CDISC teams at any time through the CDISC WebsiteRespond to a CFAST call for participation for specific roles on named projects (e.g., Clinical SME for Dyslipidemia, Medical Writer Diabetic Nephrology)Seek management approval to apply for a position in the proposed new CDISC Fellows Program – discussed in this presentationThis will both maintain continuity between CFAST projects as well as build expertise in sponsoring organizations (Industry, CROs, Vendors)Participate in the future collective management of CDISC standards as part of a proposed new CDISC SHARE Metadata Curation Collaboration initiativePlanned for details to be discussed separately later.