OASIS

Electronic Trial Master File Standard

Technical Committee

Aug 3, 2015

9:00 – 10:00 AM PDT

Agenda

2

Topic Presenter

9:00 - 9:05 Call to Order Chair

9:05 - 9:10 Roll Call Zack

9:10 – 9:12 OASIS eTMF Standard update Zack

9:12 – 9:22 TMF Ref Model v3.0 All

9:30 – 9:40 Audit trail spec All

9:40 – 9:50 New Business All

9:50 – 9:55 Agenda – next meeting All

Roll Call

Name Company Status

Jenny Huang AT&T Observer

Jennifer Alpert Palchak CareLex Member

Aliaa Badr CareLex Member

Oleksiy (Alex) Palinkash CareLex Member

Beau Grignon Forte Research Systems Member

Troy Jacobson Forte Research Systems Member

Junichi Ishida Fujitsu Limited Member

Mead Walker Health Level 7 (HL7) Member

Sharon Elcombe Mayo Clinic Member

Robert Gehrke Mayo Clinic Member

Rich Lustig Oracle Member

Lorie McClain Oracle Member

Michael Agard Paragon Solutions Member

Karen McCarthy Schau Paragon Solutions Member

Chris McSpiritt Paragon Solutions Member

Jamie O'Keefe Paragon Solutions Member

Fran Ross Paragon Solutions Member

Peter Alterman SAFE-BioPharma Association Member

Catherine Schmidt SterlingBio Member

Lou Chappuie SureClinical Member

Chris Ibell SureClinical Member

Ayrat Sadreev SureClinical Member

Zack Schmidt, Chair SureClinical Member

Trish Whetzel SureClinical Member

Accomplished –

• Published eTMF standard spec, metadata and machine code for public comment

• Reviewed, considered and published responses to over 800 industry comments

• Updated specification, metadata and machine code based on comments

• Working with National Cancer Institute to finalize the NCI published eTMF controlled vocabulary

• Completed development of standards-based eTMF audit log format

To be Done –

• Publish new metadata vocabulary terms from metadata workgroup to National Cancer Institute’s Thesaurus database for public access

• Republish updated spec, metadata, and machine code for second round of public comment

• TC Review, consideration, publication of public comments on NEW work only

• Publish final Committee Specification Draft #2

• Public review, OASIS review for OASIS standard; move to review for ISO std

eTMF Standard Update

Steps on track to an ISO standard: Near term Milestones / events:

– OASIS eTMF Draft 2 Spec Publication – Sept 2015 target:

1. TC final review of spec, new metadata, machine code, audit trail, in August

– National Cancer Institute submission - Submit all new controlled vocab terms, synonyms from last public review to NCI for review, publication in NCI’s Thesaurus database:

» Publication by NCI of new controlled vocab terms, def’s, codes, URLs

» August 20 target

– TC approval to release draft 2 – Sept 7 2015 target

2. OASIS publication of committee spec draft for public comment

period – Sept 15 2015 target, 30 day public review

3. Review comments, republish committee spec draft #2

eTMF Standard Milestones

– TMF Reference model – Who are they?

• Not a standards body – Not affiliated with DIA

• DIA ‘disclaims affiliation’ with TMF RM initiative and its members

– Broad confusion in industry over use of term ‘DIA TMF RM’

– TMF RM group published v2.0 of TMF RM 25 June 2012

– TMF RM group published v3.0 of TMF RM 15 June 2015

TMF Reference Model – TMF RM 3.0

– TMF RM 3.0 – Issues:

• No sharing of TMF RM 3.0 model with OASIS, other standards bodies or public review period prior to its release

– TMF RM 3.0 and OASIS

• TMF RM V3.0 Changes are not compatible with TMF RM V2.0 model

– TMF RM 3.0 deletes approximately 10 content classifications from V2.0

– Users of TMF RM V2.0 don’t have compatibility with TMF RM V3.0 model

– OASIS eTMF model draft spec supports TMF RM 2.0

– Support for TMF RM 3.0 content classifications is possible with organization specific terms

– OASIS eTMF draft spec #1 has 100% compatibility w V2.0 TMF RM published 25 June 2012

– NCI published eTMF controlled vocabulary based on V2.0 TMF RM and CareLex metadata terms

– Discussion Issue: Should OASIS support TMF RM V3.0 or TMF RM V2.0 in this release ? – Existing users of TMF RM 2.0 wouldn’t be supported if we change to support v3.0 – How to deal with deleted classifications? – Lack of any formal review process by TMF RM group – Q: OASIS Policy? – Vote?

TMF Reference Model – TMF RM 3.0

17:00:01+06:00 Joe Smith joesmith@instance.company.com server@abc.com D832-4B33.. FDA-1572 03.01 Modify MD=Gender Male Female Corrected

Example OASIS eTMF Audit Log Record – for a single item

Timestamp Person Name Username System ID Content Item UUID

Version Type Of Change

Previous MD Value

MD Attribute Changed

New MD Value

Description Content Item Name

22:00:01+06:00 Joe Smith joesmith@instance.company.com server@abc.com D832-4B33.. FDA-1572 03.02 Modify MD=Site 11 22 Corrected

Content Item Version #: The automated version # created by the system (Audit log) Format = Free text: Examples: 10-01 or 10 or 10.1 or 10.0001A Rules for version change: None Informational only – not part of spec: (Document Version #: An internal version number, not used in this audit log. (not used in log) Example: Company ABC has contract Vn #23.4008)

22:00:01+06:00 System System@abc.com server@abc.com D832-4B33.. FDA-1572 03.02 Modify MD=Task Unapp Approv Process

• Based on Audit Log Standard, ASTM E2147 • Issue: Whether Audit Log should be a separate file or included in eTMF code package

DRAFT – not for release:

• [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 joesmith@instance.issuer.com 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: [app-instance-name@issuer.com] • [Content Item UUID] - UUID using RFC 4122, 128 bit ID of content item

• [Content Item name] - Name of item from referring system

• [Content Item Version] - Version of content item

• [Type of change] - Action on content item: Create, Modify, Delete, Approval, Completion

• [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

• [Description] - Description of log entry or reason for change. (optional)

OASIS eTMF Audit Log – Proposed Attributes

DRAFT – not for release:

• Audit Log Location

– Audit log must be included for every content item within the content item’s metadata

– Every change to a content item must be timestamped and recorded in the audit log, creating a history of changes

– Audit logs are RDF/XML

• Audit Log Exchange

– Audit logs can be exchanged in real-time or via batch methods

– The protocol or communications method for exchange is up to the systems – https, sftp, other methods may be popular

– Communications error handling is not part of this spec

• Audit Log Validation

– An audit log is valid if it passes RDF/XML validation and contains data values for the required audit log metadata attributes

– Every audit log timestamped entry must have these required audit log metadata attributes: (final review at June meeting)

• [Timestamp]* - XML XSD Offset from the UTC time by adding a positive or negative time like: <timestamp>09:30:10+06:00</timestamp>

• [Person Name] * - First, Last name of person making change; if system makes change, ‘System=person name’

• If person name = system then: Name = valid system name like system@abc.com; • Any change by system need : Type of change (optional: MD attribute changed, reason/desc of change)

• [Username] * - Person’s system username

• [system ID] * - ID of system providing info in an exchange.

• [Content Item UUID]* - UUID - globally unique ID

• [Content Item name]* - Name

• [Content Item Version]* - Version of content item -

• [Type of change]* - Create, Modify, Delete

OASIS eTMF Audit Log – Proposed Rules

• New Business

– Discussion

New Business

• Next general OASIS eTMF TC Meeting date:

– Sept 14 2015 9am-10.00am PT

• Release of OASIS eTMF Committee spec draft #2

• New business

Next Meeting(s) Agenda / Close