Transcript Document

The Road to Version 3
27th October 2014
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Created and maintained through a group of DIA
(Drug Information Association) volunteers
◦ ~350 contributors from >200 companies
Mar 2009:
1st Meeting
June 2010:
Version
1.0- 11
zones w/
associated
artifacts
Nov 2011:
Version 1.2Investigator
Site File and
1st Intro slide
set
Feb 2011:
Version
1.1Regulator
feedback
~Dec 2012: Kickoff of many Work
Groups that
support the TMF
manage-ment
process
June 2012: Version
2.0- Device,
Process-based
metadata, and IIS
Feb 2014:
Establishment of
the TMF RM
Steering Committee
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Overall coordinator time
Zone Lead identification
Zone members engagement
Collating feedback in a standardised format
Standardising review process per zone
Collections of documents vs single
documents against an artifact
11 Zones
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Trial Management
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Central Trial Documents
Regulatory
IRB/IEC and other Approvals
Site Management
IP and Trial Supplies
Safety Reporting
Centralized Testing
Third Parties
Data Management
Statistics
Zone leads
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Expertise
Time
Motivation
Too Much Fun
What’s in it for
me?
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Zone Lead
Zone Team Member
Technical Team member
Communications Team Member
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“Go to” person for issue resolution
Liaison between zone and SC
Accountable for timeline delivery
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Schedule zone meetings
Lead zone meetings
Subject matter expert
Participate in cross-zone meetings for
standardization across zones
Resolve issues within zone (where possible)
Time estimate: Dec-May 2hrs/week
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Deputy Lead to cover when needed
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Participate in zone meetings
Review feedback from industry
Time: Dec – May 1hr/week
Qualifications; Responsibilities;
Committments
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Lead = Paul Fenton
Responsibilities to include:
◦ Presentation of the model, for example:
 Flat spreadsheet vs XML vs OWL
 Showing 3 file types – trial, country and site
◦ Interoperability
 Vocabulary
 Assess available dictionaries
 Optimization
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Provide regular status updates
DIA – keeping in the loop, publicity
LinkedIn – posting in all relevant groups
◦ Be bold in communicating we are THE TMF
Reference Model
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Vendor onboarding for publicity
Establish touch points with external
stakeholders, e.g. Regulator interaction
◦ One page summary
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Publications e.g. usability manual
V3 Controller
Aim for ~8 members
including deputy lead
V3 Controller
Deputy
SC Technical
Lead
Technical Team
Member
Technical Team
Member
SC Communication
Lead
Communication Team
Member
Communication Team
Member
SC Zone Lead
Contact
SC Zone Lead
Contact
Expert Zone
Lead
Aim for ~10 members per zone,
including deputy lead
Zone Member
Zone Member
Zone Member
Zone Member
SC Zone Lead
Contact
NOV
ALL
DEC
JAN
FEB
MAR
APR
MAY
v2 Review &
Feedback
Zone
Leads
Zone Lead
Training
Zone Leads &
Zone Members
Zone Meetings
Zone Lead Meetings
Controllers &
Steering Committee
v3 Draft
Created
Zone Leads &
Zone Members
v3 Final
Review
V3 Released –
Party Time!
JUN