oasis electronic trial master file standard technical committee may 4, 2015 9:00 – 10:30 am pdt
TRANSCRIPT
OASIS Electronic Trial Master File Standard
Technical Committee
May 4, 2015
9:00 – 10:30 AM PDT
Agenda
2
Topic Presenter
9:00 - 9:05 Call to Order Chair
9:05 - 9:10 Roll Call (secretary: Cathy ) Cathy
9:10 – 9:12 April 13 2015 minute approval All
9:12 – 9:22 OASIS eTMF Tech Workgroup – update Zack
9:22 – 9:30 New Business All9:30 – 9:40 Discussion period All
9:40 – 9:50 Agenda – next meeting All
Roll Call
Name Company StatusJenny Huang AT&T ObserverJennifer Alpert Palchak CareLex MemberAliaa Badr CareLex MemberOleksiy (Alex) Palinkash CareLex MemberBeau Grignon Forte Research Systems MemberTroy Jacobson Forte Research Systems MemberJunichi Ishida Fujitsu Limited MemberMead Walker Health Level 7 (HL7) MemberSharon Elcombe Mayo Clinic MemberRobert Gehrke Mayo Clinic MemberRich Lustig Oracle MemberLorie McClain Oracle MemberMichael Agard Paragon Solutions MemberKaren McCarthy Schau Paragon Solutions MemberChris McSpiritt Paragon Solutions MemberJamie O'Keefe Paragon Solutions MemberFran Ross Paragon Solutions MemberPeter Alterman SAFE-BioPharma Association MemberCatherine Schmidt SterlingBio MemberLou Chappuie SureClinicalChris Ibell SureClinical MemberAyrat Sadreev SureClinical MemberZack Schmidt, Chair SureClinical MemberTrish Whetzel SureClinical MemberJill Malayang University of Michigan Member
Status update - eTMF Spec Workgroup April 27 2015 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 [email protected] or other text• [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: [[email protected]] • [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 1 2015 9am-10.00am PT
• eTMF Spec Workgroup update• New business
• eTMF Spec Workgroup:– Tues May 26 2015 8am-9am
• Review attribute – Version (should it be based on timestamp)
Meeting close
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