OASIS Electronic Trial Master File Standard Technical Committee

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda Comment Review Period Aug 18, 2014 9: 00 – 10: 00 AM PDT

Agenda Topic Presenter 9: 00 - 9: 02 Call to Order Jennifer 9: 02 - 9: 05 Roll Call (Minutes by Cathy) / minutes Zack 9: 05 – 9: 10 Review comments status / issues / guidance Jennifer 9: 10 – 9: 20 TC Charter Scope of Work - Refresher Zack / TC comments 9: 20 – 9: 30 Care. Lex term contribution Jennifer 9: 30 – 9: 45 Questions / Discussion / Next steps Group 9: 45 – 9: 55 New business Michael 9: 55 – 10: 00 Review next meeting times, close Jennifer 2

Roll Call Name Company Voting Status Present? Jennifer Alpert Palchak Aliaa Badr Oleksiy (Alex) Palinkash Beau Grignon Troy Jacobson Junichi Ishida Mead Walker Lou Chappuie Lisa Mulcahey Sharon Elcombe Robert Gehrke Sharon Ames Prabhat Vatsal Rich Lustig Michael Agard Chris Mc. Spiritt Jamie O'Keefe Fran Ross Peter Mc. Naney Peter Alterman Catherine Schmidt Ayrat Sadreev Zack Schmidt, Co-Chair Trish Whetzel Robin Cover Chet Ensign Care. Lex Forte Research Systems Fujitsu Limited Health Level 7 (HL 7) Individual Mayo Clinic Next. Docs Oracle Paragon Solutions Phlexglobal Ltd. SAFE-Bio. Pharma Association Sterling. Bio Sure. Clinical OASIS Member/Voter Member/1 st Meeting Member Member/Voter Member/Voter Member/2 nd Meeting Member/Voter OASIS Staff Contact

Public Review Comment Overview • Broad support for interoperability work of TC • Strong interest in support of TMF RM terms • Support for changes made to some TMF RM terms • About 825 separate comments on issues – – 554 Metadata Vocab 249 Specification 6 OWL 5 duplicate/blank (same person) • 47 non-TC members – Vendors, Sponsors, CROs, Consultants – OASIS Technical Advisory Board

Public Review Comment Themes • Alignment to TMF RM (29) • Support for interoperability work of TC • Specification – Digital/Electronic Signatures (application dev role) – Business Processes (application dev role) – Core Metadata confusion re: application (e. g. Country) • Metadata Vocab – – IRB-IEC content types vs. metadata Medical imaging content types (useage) Missing content types missing for TMF RM PT & Definition comments

Current Issues 1. TC workgroups need clarification on scope of TC work – Need to have a clear process for: Adding terms, Content Types 2. Need to follow the TC charter 3. Most comments related to terms. Need a baseline set of OASIS e. TMF terms to help us respond to comments 4. Need to prioritize review, completion of the mapping of TMF RM terms indicated as ‘Industry feedback needed’ – A Clearly defined term spreadsheet with TMF RM artifact support would help

Comment Response Guidance • TC required to provide a response to all comments • Response: – Change made or No action or Recorded for future versions • TC not required to take action on comments • All comments should consider TC policy: – Scope of Work of OASIS TC • In scope? Out of scope? • Future enhancement request?

OASIS e. TMF TC Charter/Scope Refresher • Charter designed to define the scope of work for the TC – Helps keep us on track for current release of standard – Comments / Proposals that are out of scope for current release can be valuable and can be collected in a TC document as ‘Comments for future extensions’ • Comments that are out of scope should be noted in the response as out of scope.

OASIS e. TMF TC Charter – Technology Scope • In scope of work for TC: – Content classification architecture, classification numbering/naming, model editing rules/policies, export/import formats, core metadata for: File properties, Basic audit trail properties, Classification properties, Business Process Modeling properties, Content Item properties; and Content Item Electronic and/or digital Signature related properties; modifying machine code and schema • Out of scope: – Security, authentication, encryption, external systems integration – Extending beyond the scope of work for the TC (needs more specificity, this line reads ‘out of scope is out of scope’ to me. ) • Comments that are out of scope should be noted in the response as out of scope.

OASIS e. TMF TC Charter – Vocabulary Scope • In scope of work for TC: – Content classification: Selecting terms from published sources for the OASIS e. TMF Standard controlled vocabulary: • BRIDG, Care. Lex, Dublin Core, HL 7, National Cancer Institute NCI Thesaurus, TMF Reference Model v 2. 0, and other academic, government or non-profit sources of clinical trial terms. – Metadata vocabulary for content tagging: Selecting terms from published sources for the OASIS e. TMF Standard controlled vocabulary: • BRIDG, Care. Lex, Dublin Core, HL 7, National Cancer Institute NCI Thesaurus, TMF Reference Model v 2. 0, and other academic, government or non-profit sources of clinical trial terms • Out of scope: – Defining new terms that aren’t sourced from contributed inputs or from published standards groups – Redefining term definitions or concepts – Attempting to maintain backward compatibility with external models, external systems or external schemas – Extending beyond the scope of work for the TC • Comments that are out of scope should be noted in the response as out of scope.

OASIS e. TMF Term Sourcing • Per charter: ‘The scope of the TC's work is limited to features defined in the input contributions. . ’ Input Contributions: Care. Lex TMF RM OASIS e. TMF Standard Other Input Contributions New annotation for CT: -OASIS (fixed – standard -core) -Other (Source name) (inc core)

Suggested Process – Adding Content Types • Classification Content Type terms - Adding new Content Types • Goal – minimum set of core content types for first release of standard. Steps A. Review existing Care. Lex and TMF RM classifications for existing Content Types. B. Content Types should exist in either Care. Lex, TMF RM C. Proposed Oasis Content Types not in the TC’s approved input sources are out of scope and can be added as suggestions for next release D. If Content Type terms are not in NCI, submit for inclusion

Suggested Process – Adding Metadata Terms • Metadata tagging terms - Adding new MD terms • Goal – minimum set of tagging metadata for first release of standard. Follow existing input sources. Steps A. Review existing Care. Lex and TMF RM tagging metadata, e. TMF domain metadata B. Oasis metadata should exist in either Care. Lex, TMF RM or in a published standards body term Database C. Proposed Oasis metadata terms not in the TC’s approved input sources are out of scope and can be added as suggestions for next release

New: Input Contribution Care. Lex OASIS Contribution Aug 18 2014 • Care. Lex has contributed an updated e. TMF term set: – Includes all previous terms in NCI and OASIS – Includes a Content Type for every TMF RM v 2. 0 artifact; TMF terms to be submitted to NCI thesaurus. – All Content Types marked with annotation prop: • Care. Lex (only), TMF-RM (only), Care. Lex and TMF-RM – Enables application developers to import/migrate existing TMF RM models / content into OASIS e. TMF

Bridge To e. TMF Interoperability • Care. Lex has Imported all TMF RM model artifacts into the Aug 18 2014 Care. Lex model V 1. 03 – Published as a spreadsheet, contributed to OASIS, code to be published at NCBO Bio. Portal – Care. Lex to submit any unsubmitted TMF RM artifacts (22) to NCI thesaurus • Facilitates Migration of TMF RM content to OASIS e. TMF Standard and interoperability • Annotation prop’ty enables use of OASIS/Care. Lex, TMF RM or both OASIS/Care. Lex and TMF RM e. TMF Standard Support for all TMF RM artifacts Enables Migration to Standard Care. Lex to submit TMF terms to NCI

Bridging Two Models - Example Support for both Care. Lex and TMF-RM

Motion to Review New Care. Lex Terms • Motion: “The OASIS e. TMF Standard TC hereby accepts the contribution of the Care. Lex Draft spreadsheet of terms V 1. 03, and agrees to evaluate this input contribution. ” • Proposed Steps 1. MV Workgroup to prioritize “Industry Review Needed” PTs in Care. Lex V 1. 03 spreadsheet and make recommendations on which term to use as PT – MV Workgroup to review all TMF RM artifacts in Care. Lex v 1. 03 spreadsheet to verify 100% mapping between TMF RM and Care. Lex metadata vocab spreadsheet – If acceptable, TC can adopt Care. Lex V 1. 03 terms

Suggested Comment Review Milestones • Goals / Milestones: – Clarify and vote on a baseline set of vocabulary terms by Sept 8: • Include support for 100% of all TMF RM v 2. 0 artifact terms • Finish review of ‘Industry Feedback’ terms by 8/22 (approx 40). Consider comments for those terms only. – Complete comment review/response process by Oct 17 2014 (approx 10 weeks from today) – TC finalized vote on all comment resolutions by Oct 20 – Revise and publish CSD spec by Nov 17 for review by OASIS for additional public review.

Reminder: TC Comment Resolution Workgroups review comments Workgroups recommend resolutions to TC TC discussion/agreement on resolutions TC may vote on ‘slates’ of resolutions

New Business & Next Meeting • New Business – DIA Abstract on OASIS e. TMF Standard for 2015 – Michael • MV workgroup (baseline) -: Thurs 8/21, 9 am-10 am PST » If needed, additional time: Thurs 8/28, 9 am-10 am PST • Spec workgroup meeting: Fri 8/22, 8 am-9 am PST • Next TC Full Meeting moved after Labor Day – Mon Sept 8 9 am-10 am PST – Roll call – Joint Review Public comments log – New business