OASIS Electronic Trial Master File Standard Technical

Committee

Meeting AgendaComment Review Period

Aug 18, 2014

9:00 – 10:00 AM PDT

Agenda

2

Topic Presenter

9:00 - 9:02 Call to Order Jennifer

9:02 - 9:05 Roll Call (Minutes by Cathy) / minutes Zack

9:05 – 9:10 Review comments status / issues / guidance Jennifer

9:10 – 9:20 TC Charter Scope of Work - Refresher Zack / TC comments

9:20 – 9:30 CareLex term contribution Jennifer

9:30 – 9:45 Questions / Discussion / Next steps Group

9:45 – 9:55 New business Michael

9:55 – 10:00 Review next meeting times, close Jennifer

Roll CallName Company Voting Status Present?Jennifer Alpert Palchak CareLex Member/Voter Aliaa Badr CareLex Member/Voter Oleksiy (Alex) Palinkash CareLex Member/Voter Beau Grignon Forte Research Systems Member Troy Jacobson Forte Research Systems Member/Voter Junichi Ishida Fujitsu Limited Member/1st MeetingMead Walker Health Level 7 (HL7) Member Lou Chappuie Individual Member/Voter Lisa Mulcahey Individual Member Sharon Elcombe Mayo Clinic Member/Voter Robert Gehrke Mayo Clinic Member Sharon Ames NextDocs Member/Voter Prabhat Vatsal NextDocs Member Rich Lustig Oracle Member/Voter Michael Agard Paragon Solutions Member/Voter Chris McSpiritt Paragon Solutions Member Jamie O'Keefe Paragon Solutions Member Fran Ross Paragon Solutions Member/Voter Peter McNaney Phlexglobal Ltd. Member Peter Alterman SAFE-BioPharma Association Member/Voter Catherine Schmidt SterlingBio Member/Voter Ayrat Sadreev SureClinical Member/2nd MeetingZack Schmidt, Co-Chair SureClinical Member/Voter Trish Whetzel SureClinical Member/Voter Robin Cover OASIS OASIS Staff Contact Chet Ensign OASIS OASIS 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

OASISeTMF

Standard

CareLex TMF RM Other InputContributions

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 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

New: Input Contribution

• 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

Bridge To eTMF Interoperability

Support for all TMF RM artifactsEnables Migration to Standard

CareLex to submit TMF terms to NCI

eTMF Standard

Bridging Two Models - ExampleSupport 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 17 2014 (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