OASIS Electronic Trial Master File Standard Technical Committee

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda May 19, 2014 9: 00 – 10: 00 AM PDT

Agenda Topic Presenter 9: 00 -9: 05 Call to Order Jennifer Alpert 9: 05 -9: 10 Roll Call & Approval of Minutes Troy Jacobson 9: 10 -9: 30 Working Draft Specification Discussion All 9: 30 -9: 45 Metadata Vocabulary Layer Development Jennifer 9: 45 -9: 50 New Business All 9: 50 -10: 00 Next Meeting Agenda / Date Jennifer 2

Roll Call

Meeting Etiquette • Announce your name prior to making comments or suggestions • Keep your phone on mute when not speaking • Do not put your phone on hold – Hang up and dial in again when finished with your other call – Hold = Elevator Music = very frustrated speakers and participants • Meetings will be recorded and posted – Another reason to keep your phone on mute when not speaking! • Use the join. me “Chat” feature for questions / comments • We will follow Robert’s Rules of Order NOTE: This meeting is being recorded and will be posted on the project Wiki page after the meeting 4 From e. TMF Std TC to Participants: Hi everyone: remember to keep your phone on mute

Working Draft Spec Discussion • Has every member reviewed the Working Draft Spec (WDS)? • Editor replies posted (2) • Comments/Questions/Discussion

Application Architecture Context Presentation Layer Presentation Display Labels Fields Forms Presentation Layer = What User Sees Application Services Layer Phase II Work RDF/XML Metadata Vocab Digital Signature Bus. Process Mgt Data Services Layer Persistent Data Storage Interoperable Data Exchange © Care. Lex 2014 Phase I Work

Sponsor CRO List of SOPs Current During Trial Kickoff Meeting Material General IRB-IEC Filenote Relevant Communications (stats) SOPs Boot up Meeting Material Institutional Review Bd Notes Stats Correspondence Digital Content e. TMF Metadata Vocabulary RDF/XML Code BRIDG TMF RM Care. Lex NCI Dublin Core HL 7 e. TMF Standard Backend Architecture Components Invisible to users SOP List Kickoff Meeting Material IRB-IEC Filenote Statistics Communication Digital Content Viewable by users Display Labels: End User Views

EVS e. TMF Terms/Defs Development • Nearly 400 ‘Terms’ Submitted by Care. Lex to NCI EVS from multiple sources – Preferred Term – Definition – Synonyms – Abbreviation – Term Source URLs – Care. Lex Unique Identifying Code – Term Source

e. TMF Domain Terms/Defs/Codes e. TMF Domain NCI EVS BRIDG (CDISC) Care. Lex Dublin Core TMF RM NCIt © Care. Lex 2014

EVS e. TMF Terms/Defs Development • Term/Def Agreement (noun-noun or verb-verb) – Term: Site Selection Documentation Is it a document or action? – TMF RM original Def: ‘To document site feasibility for the given protocol. ’ verb – NCI accepted Def: Documentation describing the site feasibility for the given protocol. [TMF-RM] noun

EVS e. TMF Terms/Defs Development • Specificity of terms & definitions independent of domain – Term: Clinical Trial Notification to Investigators of Safety Information – Term: Reference Range: • To define acceptable limits (where 95% of the population that a facility serves will fall) for comparative interpretation that allow for medical decisions to be made; may be included in Lab Manual. [TMF RM] • A set of values of particular type of measurement that is used to interpret corresponding observation results. [NCI]

EVS e. TMF Terms/Defs Development • Continuity with broader NCIt taxonomy practices – CV NCI def: ‘Summary of educational and work experience qualifications and eligibility of…’ – Original TMF RM Def: To document qualifications and eligibility of Trial Team Members, including sponsor and 3 rd Party. May be indication of where these are filed – Trials Team Member CV: A summary of educational and work experience qualifications and eligibility of Trial Team Members, sponsor and third parties.

EVS e. TMF Terms/Defs Development • Human (text) and computer-readable definitions – Avoid too narrow a definition • use ‘including but not limited to’ – – – Avoid vague words (general, issue, appropriate) No extra spaces Correct spelling and punctuation Only machine-readable characters No Latin or profession-specific ‘jargon’ No use of i. e. or e. g.

Terms/Defs Development Recap • Nearly 400 ‘Terms’ Submitted by Care. Lex to NCI EVS from multiple sources • NCI EVS assessed metadata terms and definitions – From broad clinical trials and health research context for applicability and to mitigate conflicts with other domain vocabularies – Follow US Federal and international coding standards – Proposed changes for better standardization • Care. Lex re-reviewed/updated every term (PT)/definition • NCI publishes in NCIt

New Business & Next Meeting • New Business • Draft Agenda for June 2: – Roll call – Metadata Vocabulary Layer Terms/Definitions Review – Working Draft Spec Questions – New business