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Aug 18, 2014 9:00 – 10:00 AM PDT

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda Comment Review Period. Aug 18, 2014 9:00 – 10:00 AM PDT. Agenda. Roll Call. Public Review Comment Overview. Broad support for interoperability work of TC Strong interest in support of TMF RM terms

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Aug 18, 2014 9:00 – 10:00 AM PDT

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

  2. Agenda

  3. Roll Call

  4. 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

  5. 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

  6. Current Issues • TC workgroups need clarification on scope of TC work • Need to have a clear process for: Adding terms, Content Types • Need to follow the TC charter • Most comments related to terms. Need a baseline set of OASIS eTMF terms to help us respond to comments • 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

  7. 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?

  8. OASIS eTMF 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.

  9. OASIS eTMF 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.

  10. OASIS eTMF TC Charter – Vocabulary Scope • In scope of work for TC: • Content classification: Selecting terms from published sources for the OASIS eTMF Standard controlled vocabulary: • BRIDG, CareLex, Dublin Core, HL7, National Cancer Institute NCI Thesaurus, TMF Reference Model v2.0, 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 eTMF Standard controlled vocabulary: • BRIDG, CareLex, Dublin Core, HL7, National Cancer Institute NCI Thesaurus, TMF Reference Model v2.0, 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.

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

  12. 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 • Review existing CareLex and TMF RM classifications for existing Content Types. • Content Types should exist in either CareLex, TMF RM • 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 • If Content Type terms are not in NCI, submit for inclusion

  13. 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 • Review existing CareLex and TMF RM tagging metadata, eTMF domain metadata • Oasis metadata should exist in either CareLex, TMF RM or in a published standards body term Database • 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

  14. New: Input Contribution CareLex OASIS Contribution Aug 18 2014 • CareLex has contributed an updated eTMF term set: • Includes all previous terms in NCI and OASIS • Includes a Content Type for every TMF RM v2.0 artifact; TMF terms to be submitted to NCI thesaurus. • All Content Types marked with annotation prop: • CareLex (only), TMF-RM (only), CareLex and TMF-RM • Enables application developers to import/migrate existing TMF RM models / content into OASIS eTMF

  15. Bridge To eTMF Interoperability • CareLex has Imported all TMF RM model artifacts into the Aug 18 2014 CareLex model V1.03 • Published as a spreadsheet, contributed to OASIS, code to be published at NCBO BioPortal • CareLex to submit any unsubmitted TMF RM artifacts (22) to NCI thesaurus • Facilitates Migration of TMF RM content to OASIS eTMF Standard and interoperability • Annotation prop’ty enables use of OASIS/CareLex, TMF RM or both OASIS/CareLex and TMF RM eTMF Standard Support for all TMF RM artifacts Enables Migration to Standard CareLex to submit TMF terms to NCI

  16. Bridging Two Models - Example Support for both CareLex and TMF-RM

  17. Motion to Review New CareLex Terms • Motion: “The OASIS eTMF Standard TC hereby accepts the contribution of the CareLex Draft spreadsheet of terms V1.03, and agrees to evaluate this input contribution.” • Proposed Steps • MV Workgroup to prioritize “Industry Review Needed” PTs in CareLex V1.03 spreadsheet and make recommendations on which term to use as PT • MV Workgroup to review all TMF RM artifacts in CareLex v1.03 spreadsheet to verify 100% mapping between TMF RM and CareLex metadata vocab spreadsheet • If acceptable, TC can adopt CareLex V1.03 terms

  18. 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 v2.0 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 (approx10 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.

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

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

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