Discovering Road Speed Limits
Delve into the intricacies of road speed limits and their tagging percentages. Unravel why certain speed limits remain unmarked and the challenges faced in incorporating legislative changes. Explore the significance of mapping speed limits accurately and the varying sources that influence such data.
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Presentation Transcript
The Road to Version 3 27thOctober 2014
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 Mar 2009: 1st Meeting Nov 2011: Version 1.2- Investigator Site File and 1st Intro slide set ~Dec 2012: Kick- off of many Work Groups that support the TMF manage-ment process Feb 2011: Version 1.1- Regulator feedback Feb 2014: Establishment of the TMF RM Steering Committee June 2012: Version 2.0- Device, Process-based metadata, and IIS
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
Zone leads Expertise Time Motivation Too Much Fun 11 Zones Trial Management Central Trial Documents Regulatory IRB/IEC and other Approvals Site Management IP and Trial Supplies Safety Reporting Centralized Testing Third Parties Data Management Statistics What s in it for me?
Zone Lead Zone Team Member Technical Team member Communications Team Member
Go to person for issue resolution Liaison between zone and SC Accountable for timeline delivery
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
Participate in zone meetings Review feedback from industry Time: Dec May 1hr/week Qualifications; Responsibilities; Committments
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
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
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 SC Zone Lead Contact Expert Zone Lead Aim for ~10 members per zone, including deputy lead Zone Member Zone Member Zone Member Zone Member
NOV DEC JAN FEB MAR APR MAY JUN v2 Review & Feedback ALL Zone Lead Training Zone Leads Zone Meetings Zone Lead Meetings Zone Leads & Zone Members v3 Draft Created Controllers & Steering Committee v3 Final Review Zone Leads & Zone Members V3 Released Party Time!
