OASIS Electronic Trial Master File Standard Technical Committee May 4, :00 – 10:30 AM PDT

Agenda 2 TopicPresenter 9:00 - 9:05Call to OrderChair 9:05 - 9:10Roll Call (secretary: Cathy )Cathy 9:10 – 9:12April minute approvalAll 9:12 – 9:22OASIS eTMF Tech Workgroup – updateZack 9:22 – 9:30New BusinessAll 9:30 – 9:40Discussion periodAll 9:40 – 9:50Agenda – next meetingAll

Roll Call NameCompanyStatus Jenny HuangAT&TObserver Jennifer Alpert PalchakCareLexMember Aliaa BadrCareLexMember Oleksiy (Alex) PalinkashCareLexMember Beau GrignonForte Research SystemsMember Troy JacobsonForte Research SystemsMember Junichi IshidaFujitsu LimitedMember Mead WalkerHealth Level 7 (HL7)Member Sharon ElcombeMayo ClinicMember Robert GehrkeMayo ClinicMember Rich LustigOracleMember Lorie McClainOracleMember Michael AgardParagon SolutionsMember Karen McCarthy SchauParagon SolutionsMember Chris McSpirittParagon SolutionsMember Jamie O'KeefeParagon SolutionsMember Fran RossParagon SolutionsMember Peter AltermanSAFE-BioPharma AssociationMember Catherine SchmidtSterlingBioMember Lou ChappuieSureClinical Chris IbellSureClinicalMember Ayrat SadreevSureClinicalMember Zack Schmidt, ChairSureClinicalMember Trish WhetzelSureClinicalMember Jill MalayangUniversity of MichiganMember

Status update - eTMF Spec Workgroup April meeting: –Spec: Discussed enhanced audit trail format –TBD: Finalize format attributes –Based on ASTM E2147 –To be done: »Publish new metadata for audit trail for public comment »Update as needed, publish to NCI Thesaurus »Republish updated machine code and revised spec eTMF Spec Workgroup Update

[Timestamp] - GMT +/- local offset – 00:00:00 +[offset] (std format xml def) [Person Name] - First, Last name of person making change [Username] - (system username ) Ex: joesmith or or other [system ID] - ID of system providing info in an exchange. instance.issuer.com Purpose: identify the organization Application instance name (unique name – text ?) Purpose is for ID’ing app instances of same app within an organization Attribute: [Content Item UUID] - UUID using RFC 4122, 128 bit ID of content item [Content Item name] - Name of item from referring system [Content Item Major.minor vn] - Version of content item (discussion: version based on timestamp) [Type of change] - User action on content item: Create, Modify, Delete [MD Attribute Changed] - If item modified is metadata – list MD attribute name. [prev MD value] – If MD change, list the previous MD value [new value] - If MD change, list the new MD value [Reason for change] - Description or reason for change. Applies to content item or MD value change (optional) OASIS eTMF Audit Log – Proposed Attributes

New Business –Discussion New Business

General OASIS eTMF TC Meeting date: –June am-10.00am PT eTMF Spec Workgroup update New business eTMF Spec Workgroup: –Tues May am-9am Review attribute – Version (should it be based on timestamp) Meeting close Next Meeting(s) Agenda / Close