Technical Committee Meeting Agenda June 2, 2014 9:00 10:00 AM PDT - - PowerPoint PPT Presentation

OASIS Electronic Trial Master File Standard Technical Committee

Meeting Agenda

June 2, 2014 9:00 – 10:00 AM PDT

Agenda

2

Topic Presenter

9:00 - 9:05 Call to Order Zack Schmidt 9:05 - 9:10 Roll Call and Approval of Minutes Jennifer / Troy Jacobson 9:10 – 9:12 TC Workgroups Status Zack Schmidt 9:12 - 9:15 Charter Objectives – Draft for Public Review Zack Schmidt 9:15 - 9:20 Proposed Timeline and Action Plan Zack Schmidt 9:20 - 9:30 Metadata Vocabulary Workgroup Status Metadata group /Jennifer 9:30 - 9:40 Specification Workgroup Status Editor group/Aliaa 9:40 - 9:50 New Business All 9:50 - 10:00 Next Meeting Agenda/Date Zack

Roll Call

Last Name Company Voting Status Present?

Jennifer Alpert Palchak, Co-Chair 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 Mead Walker, HL7 Liaison Health Level Seven (HL7) Member/ 2nd mtng Lou Chappuie Individual Member/Voter Lisa Mulcahy Individual Member Sharon Elcombe Mayo Clinic Member/Voter Robert Gehrke Mayo Clinic Member Tom Johnson Mayo Clinic Member Sharon Ames NextDocs Member/2nd mtng Prabhat Vatsal NextDocs Member/1st mtng Robin Cover OASIS OASIS Staff Contact Chet Ensign OASIS OASIS Staff Contact Rich Lustig Oracle Member/Voter Michael Agard Paragon Solutions Member/Voter Chris McSpiritt Paragon Solutions Member/Voter Jamie O'Keefe Paragon Solutions Member/Voter Fran Ross Paragon Solutions Member/Voter Peter McNaney Phlexglobal Ltd. Member/ 2nd mtng Peter Alterman SAFE-BioPharma Assn Member/Voter Catherine Schmidt SterlingBio Member/Voter Ayrat Sadreev SureClinical Member/ 1st mtng Zack Schmidt, Co-Chair SureClinical Member/Voter Trish Whetzel SureClinical Member/Voter Stephen Scribner EMC Observer Laura Hilty Forte Research Systems Observer Tony O'Hare Forte Research Systems Observer Jill Malayang University of Michigan Observer

Meeting Etiquette

• Announce your name prior to making comments or suggestions
• Keep your phone on mute when not speaking
• Do not put your phone on hold

– Hang up and dial in again when finished with your other call – Hold = Elevator Music = very frustrated speakers and participants

• Meetings will be recorded and posted

– Another reason to keep your phone on mute when not speaking!

• Use the join.me “Chat” feature for questions / comments
• We will follow Robert’s Rules of Order

NOTE: This meeting is being recorded and will be posted on the project Wiki page after the meeting

From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute 

4

• Specification Workgroup

– Create, edit, publish Oasis eTMF specification

• Aliaa – Jennifer, Rich, Airat, Zack (others?)
• Metadata Vocab Workgroup

– Create, edit, publish Oasis metadata terms

• Jennifer - Fran, Mike, Sharon A., Zack
• Technical Workgroup

– Create, edit, publish Oasis RDF/XML code

• Oleksiy - Zack

Workgroups

 Two workgroups formed last week (Note – ‘Workgroups’, not Subcommittees)  Workgroups are open to all.  Meeting dates/times and how to participate need to be published. New 

• Why:

– Important to get feedback from agencies, industry

• Who will review:

– Open to anyone / any org – Agencies targeted:

• FDA, EMA, CFDA, Japan MH

– Standards groups targeted:

• HL7, CDISC, PhUSE/FDA; Open to all
• How:

– Publicity, outreach – Done by Oasis PR for our TC

• Question: When will we be ready to publish draft?

Charter Objective – Publish Draft Spec for Public Review June 2014

Tasks and status: – Draft specification – approved for public review by TC

• Status – Ready for group review this week

– Metadata vocabulary term review

• TMF RM cross –ref check - Fran and Michael Agard (6/3)
• Preferred term selection (NCI PT or Pref term submitted) - TBD
• Add any new terms as needed, updates (TMF RM synonyms, etc)
• Review all term abbreviations
• Status – Great progress. Two more workgroup meetings?

– OASIS RDF/XML code updated (new NCI codes, URLs, etc.)

• Status – Can be done in 2-3 days

Charter Objective – Publish Draft Spec for Public Review June 2014

Charter Objective – Draft Spec Publication - Proposed Timeline

MD Review 1 Tues 6/3 MD Review 2 Fri 6/6 TC Meeting Mon 6/9 Goal: Draft CSD TC Meeting Mon 6/2 TC Meeting Mon 6/13 Goal: Draft Public Spec Spec Review 1 Mon 6/2 Spec Review Code Review MD Review Motion to publish draft Goal: Draft Spec Available for Public Review, 6/13 TC Meeting Mon 6/23

• Goal of workgroup in TC context:

– To define machine readable formats for clinical trial master file content interoperability and data exchange to include an eTMF content classification model comprised of a standards- based vocabulary and a content classification

• ntology

Metadata Vocab Layer Workgroup

eTMF Standard Backend Architecture Components

SOP List Kickoff Meeting Material IRB-IEC Filenote Statistics Communication

BRIDG NCI CareLex TMF RM Dublin Core HL7

Display Labels: End User Views

List of SOPs Current During Trial Kickoff Meeting Material General IRB-IEC Filenote Relevant Communications (stats) SOPs Boot up Meeting Material Institutional Review Bd Notes Stats Correspondence Digital Content Digital Content

Sponsor CRO

Viewable by users Invisible to users

eTMF Metadata Vocabulary

NCI Thesaurus

Oasis RDF/XML Code

• Essential Workgroup Tasks:

– Assess & confirm cross reference codes to TMF RM

• Fran Ross & Michael Agard are leading effort

– Select a controlled vocab term set

• NCI Preferred Term
• Preferred Terms submitted by CareLex to NCI
• 5/30 meeting slides and recording from workgroup

available

Metadata Vocab Layer Workgroup

NCI - eTMF Metadata Vocab

Category (C) Annotation Property (PA) Data Property (PD) NCIt Code NCIt Preferred Term Preferred Term Submitted Synonym Category Code Cross Reference (TMF-RM V2.0_25Jun e12) C C115782 Clinical Trial Site Management Documentation Site Management Category 104 C C115669 Clinical Trial Site Initiation Documentation Site Initiation Subcategory 104.12 C C115576 Clinical Trial Initiation Monitoring Report Trial Initiation Monitoring Report Site Initiation Visit Report T104.12.10 102 C C115604 Clinical Trial Site Training Material Site Training Material T104.12.11 103 C C115674 Clinical Trial Site Training Completion Document Site Training Documentation Training completion documentation T104.12.12 104 C C115696 Institutional Review Board Independent Ethics Committee Human Subject in Research Approval Documentation IRB-IEC Documents Subcategory Institutional Review Board Independent Ethics Committee Documents|IRB/IEC Trial Approval 104.13 C C115616 Institutional Review Board Independent Ethics Committee Submission IRB-IEC Submission Institutional Review Board Independent Ethics Committee Submission|IRB/IEC Submission T104.13.10

1 2 3 6 7 4 5

• Review comments/edits in latest revision of working draft

– Zack - Summary of status - Aliaa Badr, Workgroup Lead Editor Most recent comments:

• Rich - comment on TMF RM and Oasis eTMF

– Added - TMF RM / Oasis eTMF term cross-referencing

• Airat - comment – Should URLs for organization-specific terms be

editable?

• Jennifer - update to graphics needed / content classification section

– TBD by Aliaa

• Zack - Core metadata terms, data/annotation prop’s updated with new NCI

code (draft)

Specification Workgroup

• New Business
• Draft Agenda for TC meeting Monday June 9: 9am-10am PST

– Roll call – Working Draft Spec Review – Metadata Vocabulary Layer Workgroup report – List of public review outreach contacts – Draft Press release? From Oasis if avail – Review intro to Oasis eTMF slides (outline only) – New business – Add Friday June 13 meeting 9am-10am PST

• Motion to adopt draft spec and publish for public review

New Business & Next Meeting