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

Agenda 2 TopicPresenter 9:00 - 9:02Call to OrderJennifer 9:02 - 9:05Roll Call (Minutes by Cathy) / minutesZack 9:05 – 9:10Review comments status / issues / guidanceJennifer 9:10 – 9:20TC Charter Scope of Work - RefresherZack / TC comments 9:20 – 9:30CareLex term contributionJennifer 9:30 – 9:45Questions / Discussion / Next stepsGroup 9:45 – 9:55New businessMichael 9:55 – 10:00Review next meeting times, closeJennifer

Roll Call NameCompanyVoting StatusPresent? Jennifer Alpert PalchakCareLexMember/Voter Aliaa BadrCareLexMember/Voter Oleksiy (Alex) PalinkashCareLexMember/Voter Beau GrignonForte Research SystemsMember Troy JacobsonForte Research SystemsMember/Voter Junichi IshidaFujitsu LimitedMember/1st Meeting Mead WalkerHealth Level 7 (HL7)Member Lou ChappuieIndividualMember/Voter Lisa MulcaheyIndividualMember Sharon ElcombeMayo ClinicMember/Voter Robert GehrkeMayo ClinicMember Sharon AmesNextDocsMember/Voter Prabhat VatsalNextDocsMember Rich LustigOracleMember/Voter Michael AgardParagon SolutionsMember/Voter Chris McSpirittParagon SolutionsMember Jamie O'KeefeParagon SolutionsMember Fran RossParagon SolutionsMember/Voter Peter McNaneyPhlexglobal Ltd.Member Peter AltermanSAFE-BioPharma AssociationMember/Voter Catherine SchmidtSterlingBioMember/Voter Ayrat SadreevSureClinicalMember/2nd Meeting Zack Schmidt, Co-ChairSureClinicalMember/Voter Trish WhetzelSureClinicalMember/Voter Robin CoverOASISOASIS Staff Contact Chet EnsignOASISOASIS Staff Contact

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 Overview

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 Public Review Comment Themes

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 eTMF 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 Current Issues

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? Comment Response Guidance

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 eTMF TC Charter/Scope Refresher

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 eTMF TC Charter – Technology 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. OASIS eTMF TC Charter – Vocabulary Scope

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

Classification Content Type terms - Adding new Content Types Goal – minimum set of core content types for first release of standard. Steps A.Review existing CareLex and TMF RM classifications for existing Content Types. B.Content Types should exist in either CareLex, 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 Content Types

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 CareLex and TMF RM tagging metadata, eTMF domain metadata B.Oasis metadata should exist in either CareLex, 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 Suggested Process – Adding Metadata Terms

CareLex OASIS Contribution Aug 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 New: Input Contribution

CareLex has Imported all TMF RM model artifacts into the Aug CareLex model V1.03 –Published as a spreadsheet, contributed to OASIS, code to be published at NCBO BioPortalNCBO 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 Bridge To eTMF Interoperability Support for all TMF RM artifacts Enables Migration to Standard CareLex to submit TMF terms to NCI Support for all TMF RM artifacts Enables Migration to Standard CareLex to submit TMF terms to NCI eTMF Standard

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

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 1.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 Motion to Review New CareLex Terms

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 (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. Suggested Comment Review Milestones

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

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 New Business & Next Meeting