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

Agenda TopicPresenter 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 2 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

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 From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute 4

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

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

eTMF Standard Backend Architecture Components eTMF Metadata Vocabulary RDF/XML Code SOP List Kickoff Meeting Material IRB-IEC Filenote Statistics Communication BRIDG NCI CareLex TMF RM Dublin Core HL7 Display Labels: End User Views List of SOPs Current During Trial Kickoff Meeting Material General IRB-IEC Filenote Relevant Communications (stats) 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 SOPs Boot up Meeting Material Institutional Review Bd Notes Stats Correspondence Digital Content Sponsor CRO Viewable by users Invisible to users

Nearly 400 ‘Terms’ Submitted by CareLex to NCI EVS from multiple sources –Preferred Term –Definition –Synonyms –Abbreviation –Term Source URLs –CareLex Unique Identifying Code –Term Source EVS eTMF Terms/Defs Development

eTMF Domain Terms/Defs/Codes © CareLex 2014 NCI EVS eTMF Domain BRIDG (CDISC) NCIt Dublin Core CareLex TMF RM

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 eTMF 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 eTMF 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 3rd 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 eTMF 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. EVS eTMF Terms/Defs Development

Nearly 400 ‘Terms’ Submitted by CareLex 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 CareLex re-reviewed/updated every term (PT)/definition NCI publishes in NCIt Terms/Defs Development Recap

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