Technical Committee Meeting Agenda June 2, 2014 9:00 10:00 AM PDT - PowerPoint PPT Presentation

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda June 2, 2014 9:00 – 10:00 AM PDT

Agenda Topic Presenter 9:00 - 9:05 Call to Order Zack Schmidt 9:05 - 9:10 Roll Call and Approval of Minutes Jennifer / Troy Jacobson 9:10 – 9:12 TC Workgroups Status Zack Schmidt 9:12 - 9:15 Charter Objectives – Draft for Public Review Zack Schmidt 9:15 - 9:20 Proposed Timeline and Action Plan Zack Schmidt 9:20 - 9:30 Metadata Vocabulary Workgroup Status Metadata group /Jennifer 9:30 - 9:40 Specification Workgroup Status Editor group/Aliaa 9:40 - 9:50 New Business All 9:50 - 10:00 Next Meeting Agenda/Date Zack 2

Roll Call Last Name Company Voting Status Present? Jennifer Alpert Palchak, Co-Chair CareLex Member/Voter Aliaa Badr CareLex Member/Voter Oleksiy (Alex) Palinkash CareLex Member/Voter Beau Grignon Forte Research Systems Member Troy Jacobson Forte Research Systems Member/Voter Member/ 2 nd mtng Mead Walker, HL7 Liaison Health Level Seven (HL7) Lou Chappuie Individual Member/Voter Lisa Mulcahy Individual Member Sharon Elcombe Mayo Clinic Member/Voter Robert Gehrke Mayo Clinic Member Tom Johnson Mayo Clinic Member Member/2 nd mtng Sharon Ames NextDocs Member/1 st mtng Prabhat Vatsal NextDocs Robin Cover OASIS OASIS Staff Contact Chet Ensign OASIS OASIS Staff Contact Rich Lustig Oracle Member/Voter Michael Agard Paragon Solutions Member/Voter Chris McSpiritt Paragon Solutions Member/Voter Jamie O'Keefe Paragon Solutions Member/Voter Fran Ross Paragon Solutions Member/Voter Member/ 2 nd mtng Peter McNaney Phlexglobal Ltd. Peter Alterman SAFE-BioPharma Assn Member/Voter Catherine Schmidt SterlingBio Member/Voter Ayrat Sadreev SureClinical Member/ 1st mtng Zack Schmidt, Co-Chair SureClinical Member/Voter Trish Whetzel SureClinical Member/Voter Stephen Scribner EMC Observer Laura Hilty Forte Research Systems Observer Tony O'Hare Forte Research Systems Observer Jill Malayang University of Michigan Observer

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 From eTMF Std TC to Participants: Hi everyone: remember to keep your NOTE: This meeting is being recorded and will phone on mute  be posted on the project Wiki page after the meeting 4

Workgroups  Two workgroups formed last week (Note – ‘Workgroups’, not Subcommittees)  Workgroups are open to all.  Meeting dates/times and how to participate need to be published. • Specification Workgroup – Create, edit, publish Oasis eTMF specification • Aliaa – Jennifer, Rich, Airat, Zack (others?) • Metadata Vocab Workgroup – Create, edit, publish Oasis metadata terms • Jennifer - Fran, Mike, Sharon A., Zack • New  Technical Workgroup – Create, edit, publish Oasis RDF/XML code • Oleksiy - Zack

Charter Objective – Publish Draft Spec for Public Review June 2014 • Why : – Important to get feedback from agencies, industry • Who will review: – Open to anyone / any org – Agencies targeted: • FDA, EMA, CFDA, Japan MH – Standards groups targeted: • HL7, CDISC, PhUSE/FDA; Open to all • How: – Publicity, outreach – Done by Oasis PR for our TC • Question: When will we be ready to publish draft?

Charter Objective – Publish Draft Spec for Public Review June 2014 Tasks and status: – Draft specification – approved for public review by TC • Status – Ready for group review this week – Metadata vocabulary term review • TMF RM cross – ref check - Fran and Michael Agard (6/3) • Preferred term selection (NCI PT or Pref term submitted) - TBD • Add any new terms as needed, updates (TMF RM synonyms, etc) • Review all term abbreviations • Status – Great progress. Two more workgroup meetings? – OASIS RDF/XML code updated (new NCI codes, URLs, etc.) • Status – Can be done in 2-3 days

TC Meeting Mon 6/23 Goal: Draft Spec Available for Public Review, 6/13 Draft Spec Publication - Proposed Timeline TC Meeting Mon 6/13 Goal: Draft Public Spec Spec Review TC Meeting Code Review Mon 6/9 MD Review Goal: Draft CSD Motion to Charter Objective – publish draft MD Review 2 Fri 6/6 MD Review 1 Tues 6/3 TC Meeting Spec Review 1 Mon 6/2 Mon 6/2

Metadata Vocab Layer Workgroup • Goal of workgroup in TC context: – To define machine readable formats for clinical trial master file content interoperability and data exchange to include an eTMF content classification model comprised of a standards- based vocabulary and a content classification ontology

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

Metadata Vocab Layer Workgroup • Essential Workgroup Tasks: – Assess & confirm cross reference codes to TMF RM • Fran Ross & Michael Agard are leading effort – Select a controlled vocab term set • NCI Preferred Term • Preferred Terms submitted by CareLex to NCI • 5/30 meeting slides and recording from workgroup available

NCI - eTMF Metadata Vocab 1 2 3 4 5 6 7 Category (C) Cross Annotation Reference NCIt Property (PA) NCIt Preferred Term Preferred Term Submitted Synonym Category Code (TMF-RM Code Data Property V2.0_25Jun (PD) e12) C C115782 Clinical Trial Site Management Site Management Category 104 Documentation C C115669 Clinical Trial Site Initiation Site Initiation Subcategory 104.12 Documentation C C115576 Clinical Trial Initiation Trial Initiation Monitoring Site Initiation Visit T104.12.10 102 Monitoring Report Report Report C C115604 Clinical Trial Site Training Site Training Material T104.12.11 103 Material C C115674 Clinical Trial Site Training Site Training Documentation Training completion T104.12.12 104 Completion Document documentation C C115696 Institutional Review Board IRB-IEC Documents Institutional Review 104.13 Independent Ethics Committee Subcategory Board Independent Human Subject in Research Ethics Committee Approval Documentation Documents|IRB/IEC Trial Approval C C115616 Institutional Review Board IRB-IEC Submission Institutional Review T104.13.10 Independent Ethics Committee Board Independent Submission Ethics Committee Submission|IRB/IEC Submission

Specification Workgroup • Review comments/edits in latest revision of working draft – Zack - Summary of status - Aliaa Badr, Workgroup Lead Editor Most recent comments: • Rich - comment on TMF RM and Oasis eTMF – Added - TMF RM / Oasis eTMF term cross-referencing • Airat - comment – Should URLs for organization-specific terms be editable? • Jennifer - update to graphics needed / content classification section – TBD by Aliaa • Zack - Core metadata terms, data/annotation prop’s updated with new NCI code (draft)

New Business & Next Meeting • New Business • Draft Agenda for TC meeting Monday June 9: 9am-10am PST – Roll call – Working Draft Spec Review – Metadata Vocabulary Layer Workgroup report – List of public review outreach contacts – Draft Press release? From Oasis if avail – Review intro to Oasis eTMF slides (outline only) – New business – Add Friday June 13 meeting 9am-10am PST • Motion to adopt draft spec and publish for public review