1. The Road to Version 3 27 th October 2014

2.  Created and maintained through a group of DIA (Drug Information Association) volunteers ◦ ~350 contributors from >200 companies June 2010: Version 1.0- 11 zones w/ associated artifacts Feb 2011: Version 1.1- Regulator feedback Nov 2011: Version 1.2- Investigator Site File and 1 st Intro slide set June 2012: Version 2.0- Device, Process-based metadata, and IIS Mar 2009: 1 st Meeting ~Dec 2012: Kick- off of many Work Groups that support the TMF manage-ment process Feb 2014: Establishment of the TMF RM Steering Committee

3.  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

4.  Zone leads ◦ Expertise ◦ Time ◦ Motivation ◦ Too Much Fun  What’s in it for me?

5.  Zone Lead  Zone Team Member  Technical Team member  Communications Team Member

6.  “Go to” person for issue resolution  Liaison between zone and SC  Accountable for timeline delivery

7.  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  Deputy Lead to cover when needed

8.  Participate in zone meetings  Review feedback from industry  Time: Dec – May 1hr/week  Qualifications; Responsibilities; Committments

9.  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

10.  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  Vendor onboarding for publicity  Establish touch points with external stakeholders, e.g. Regulator interaction ◦ One page summary  Publications e.g. usability manual

11. V3 Controller SC Zone Lead Contact Expert Zone Lead Zone Member SC Zone Lead Contact SC Technical Lead Technical Team Member V3 Controller Deputy SC Communication Lead Communication Team Member Aim for ~10 members per zone, including deputy lead Aim for ~8 members including deputy lead

12. NOVDECJANFEBMARAPRMAYJUN v2 Review & Feedback Zone Lead Training Zone Meetings Zone Lead Meetings v3 Final Review v3 Draft Created ALL Zone Leads Zone Leads & Zone Members Controllers & Steering Committee Zone Leads & Zone Members V3 Released – Party Time!