TMF Reference Model Group Meeting – 14-JAN-2013

There were 65 people on today’s call! There are currently 320 members from around 200 companies. Notes from meeting:

    • New leadership committee – Chairman and core team
    • Goals to expand SIAC enrollment to other regions (Asia Pac critical)
    • Other goals to be defined across the groups (EDM RM, TMF RM, Content reuse, Framework for destruction and Cloud computing (possible))
    • Requesting showcase abstracts – 30 min presentations. TMF RM to submit one for usability, QC and metadata
    • Looking for European co-chair – any volunteers?
  • Future TMF relevant Conferences (discount vouchers available):

·         eXL TMF Summit in Arlington, USA. Will get together for dinner. Ana Ramirez, Lisa Mulcahy, Fran Ross, Bruce Pfannenstiel, Amanda Harring-Abbott, Wendy Beeby, Karen Redding attending. Who else?
·         CBI Clintech in March USA
·         DIA in Boston in June
·         ARMA conference in Las Vegas – ARMA now has a UK and European chapters
·         DIA EDM in Dublin in December

·         Usability Group

·     Members: Eric Rubinson, Steve Bioty, Annika Dansson, Sherry Marsh, Lisa Mulcahy, Fran Ross, Adair Turner, Thuy Tran, Linda Rizzo, Wendy Toney; Sharon Ames, Chan Linh, Michele Atherton, Jamie O’Keefe, Subhayen Das, Kathleen Kirby, Lisa Goines, Jamie Toth, Jennifer Choi, Ellen Liedl Sargent, Karen Redding, Rosalie Phelan, Tamika Jackson, Leah Rose.
·         Leader – Ellen Liedl Sargent
·         Goals
·   User manual – by June 2013, with case studies on how people have used the model
·   Webex of model introduction by end of 2013
·   Keep presentation of TMF Reference Model current
·         Good draft for next meeting
·         Need plan for communication of manual to community
·         Next meeting Friday 8th Feb (will be first Friday of the month)

 ·         QC group

·         Members: Sharon Ames, Billie Graci, Francisca Darmer, Robin Rimsky, Sam Mowaswes, Karen McCarthy-Shau, Barry Milton, Bruce Pfannenstiel, Michelle Ingraham, Cynthia Pinto, Jodie Salisbury, Eldin Rammell, Andrea Achatz, Sarah Hitching; Rosalie Phelan, Marie Falvo, Pam Monds, Amanda Harring-Abbott, Carlton Clark, Lisa Rakebrand, Sarah Tucker, Lisa Mulcahy, Shah Ashraf, Michele Atherton, Marie-Christine Poisson-Carvajal, Monica Chiotti, William Kiniklis, Donna Vilines, Kathie Clark, Lisa Pabion, Sherry Marsh, Patrick Zhang, Ziyad Abushima, Wendy Beeby, Shah Ashraf
·         Lead – Michael Agard from Paragon
·         Four groups with leaders appointed
·   Best practice for TMF processes e.g. filing, scanning (lead Eldin)
·   Best practice for TMF content e.g. correspondence, translations, requiring QC (lead Michael)
·   Best practice for working with a CRO e.g. eTMF (Lead Karen & Marie Christine)

·   Metrics and Reporting (lead Fran)

·         Charter completed
·         Meeting 3rd Monday of each month – next 28th December
·         Australia / Asia Pac
·         Leader – Fran Ross from Paragon
·         25 members as of Jan 1; many from trial sites
·         Strong Australia participation;  Looking to increase Japan and China members
·         Site level focus – piloting the use of the TMF Reference Model at sites. Draft model will be open for comments
·         Anyone on team want to be involved? Karen Redding, Michael Agard, Mike Czaplicki
·         Meet 2 days after the main group, 6pm pacific time, 6am India

·      Communication group

·         Lead: Maryanne Quinn
·        Members – Karen Redding, Fran Ross, Chih-Wu Chang, Jennifer Choi, Eldin Rammell, Ellen Liedl-Sargent, Michael Zwetkow, Lisa Mulcahy, Paul Fenton, Francie Rawlings, Sam Mowaswes, Kathleen Kirby, Rose-Emily Calo, Dean Gittleman, Ivan Walrath, Jan Bettina

    • Applied Clinical Trials article in draft
    • Survey results attached. Need people to volunteer for 2013 survey. Will be old team plus Kathy Moore
    • The Comms team is going to take on the current challenges of communication:

·   Where to host the TMF Reference Model

·   Where to host supporting information, articles, webinars etc


·   Q&A on the Reference Model – can we hold in a DMS or blog or website?


·   Add in how to present the different groups at conferences


    • Next Meeting – to be decided


·         Metadata group


·       Lead: Karen Redding


·           Team: Karen McCarthy Shau, Mark Shiner,  Martin Thorley (volunteered!), Joanne Ritchie, Sam Mowaswes, Sharon Ames, Janet McDougall, Karin Schneider, Don Palmer, Mary Durham, Kathie Clark, Eldin Rammell, Andrew Mitchell, Scott McGrail, Jan Bettina, Denise Desmond, Anne-Mette Varney, Lisa Ballanco, Francisca Darmer, Kathy Moore


o   Define the purpose of the metadata in the TMF Reference Model – Finding (search/navigation)


o   Define the scope of the metadata – i.e. document vs system


o   Identify the common metadata across the model


o   Identify the metadata for types of documents e.g. communications, plans


o   Identify specific metadata per artifact


o   Compliance requirements


o   Interoperability/linking


o   Agency requirement
Target February 2013 start


  • TransCelerate – 5 areas of focus – risk based monitoring, data standards, portal, comparative drug supplies. Goal for portal team is to build a portal from a site perspective, currently in RFP. Gateway to sponsor systems. Will grow to full portal with TMF capability.
  • MHRA guide has a chapter on TMF, available as an ebook on Amazon (Kindle)
  • MHRA GCP forum – TMF thread – will publish FAQs on there. We can submit questions to Andy. Please send to Karen Redding!


Next Meeting

    • February 11th  11am ET, 4pm GMT
    • Please join at least 4 calls a year, as we will be limiting membership to people who take part.

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