Meeting Minutes – 15th April 2013

  • Introductions – there were 60 people on the call
  • Currently 320 people from around 180 companies


  • Please submit abstracts by 18th April to European DIA Annual meeting
  • Need to get abstracts to DIA eCTD conference in October – call not open yet
  • Focus efforts to expand the DIA SIAC projects on AP audience
  • DRM Community meetings starting monthly – 3rd Thursday of every month, 11am.
  • DIA Connex is a challenge – Lisa taking that to DIA

 Recent and future TMF relevant Conferences (discount vouchers available for CBI and eXL):

  • CBI Clintech in Dublin – 11/12 June
  • DIA in Boston – 24-26 June
  • eXL inspection readiness & eClinical in Philadelphia – August
  • DIA Document Management/eSub – October
  • ARMA conference in Las Vegas – 28-30 October
  • eXL TMF Summit in London – 23/24 October
  • DIA EDM in Dublin – 20-22 November

Usability Group

  • Eric Rubinson, Steve Bioty, Annika Dansson, Sherry Marsh, Lisa Mulcahy, Fran Ross, Adair Turner, Thuy Tran, 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, Kim Fowler, Sarah Silvers.
  • Leader – Ellen Liedl Sargent
  • Goals
    • User manual – by June 2013, with case studies on how people have used the model.
  1. Karen Redding          Phlexglobal
  2. Martin Thorley          Pfizer
  3. Stacy Hitchman          Biogen
  • Webex of model introduction by end of 2013
  • Keep presentation of TMF Reference Model current
  • Final draft in place – some content needs to move to QC group, some to case studies
  • Need plan for communication of manual to community
  • Meeting – first Friday of the month
  • Two pathways for citing TMF Reference Model in publications.
    • Use content published in the TMF Usability guide, found here: xxx.  The content can be amended for verb tense or other readability edits, but otherwise may not be changed.
    • Send article draft to co-chairs Karen and Lisa.   They will comment only on Model history/background/contact details.  If you deliver with the appropriate section(s) in highlight, they will turn around the comments within three working days.

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, Stacy Hitchman, Suellen Bigaj, Michelle Green, Jane Twitchen, Tricia Fryer, Mike Czaplicki, Maria Shabe
  • Lead – Michael Agard from Paragon
  • Four groups with leaders appointed
    • Best practice for TMF processes e.g. filing, scanning (lead Tamika Jackson)
    • 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
  • Monthly Meeting for team leads only
  • Sub-team groups in addition

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
    • Piloting the use of the TMF Reference Model at sites – sites identified.
    • Looking for other countries to pilot the template
    • Looking for companies to volunteer to use the index
    • 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 final draft
  • No Longer a separate group – part of the main meeting

Survey Team

  • Lead: Fran Ross
  • Survey live for 2013
  • Members: Karen Redding, Kathy Moore, Jonathan Burd, Virginia Morhan, Kelley Robinson, Rahul Ganur, Jennifer Gaskin, Shah Ashraf, Suellen Bigaj
  • Communication – TMF RM Linked in group, Other Linked in groups, MAGI, SOPRA, emails, twitter, eNCAP, ACRP
  • Use this – Join your industry colleagues in making your voice heard by taking the 2013 TMF Survey. This is the 3rd generation industry-wide survey sponsored by the TMF Reference Model initiative. Our aim is to collect valuable insight into both paper and electronic Trial Master Files, at sponsor and at site; to identify trends, assess changes in practice and reveal opportunities for improvement. The survey takes less than 10 minutes to complete and closes on May 16, 2013. To thank you for your participation, you will receive a free copy of the survey results to inform you of trends in TMF / ISF practices. ———————– Survey link:

Metadata group

  • Leads: Karen Redding and Lisa Mulcahy
    • 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, Jonathan Burd, Janet McDougall; Lisa Potanovich, Todd Tullis, Colleen Maude,
      • Define the purpose of the metadata in the TMF Reference Model – Finding (search/navigation)
      • Define the scope of the metadata – i.e. document vs system
      • Identify the common metadata across the model
      • Identify the metadata for types of documents e.g. communications, plans
      • Identify specific metadata per artifact
      • Compliance requirements
      • Interoperability/linking
      • Agency requirement
  • Next meeting to booked

Other discussion topics:

  • 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. Challenging initiative. Requirements do mention TMF RM for eTMF.
  • MHRA GCP forum – TMF thread – will publish FAQs on there.


  • Discussion Points
  • How we can share materials? Q&A on the Reference Model – how can we centralize?
      • Blog could move to a different technology
        • FAQs
        • Library of resources
        • Need people – Andrew, Eldin, Jamie, Maryanne, Karen.


    • EU Directive on retention of TMFs
      • Lengthy process – vote in next 2 weeks, then months to go to parliament
      • New regulation to standardize a variety aspects
      • Revised regulation stipulates indefinite retention period for TMF documents (Sponsor and Investigator)
      • Proposes archiving in EU database, which was proposed for subject data
      • No formal mechanism for feedback to be submitted. Member of European Parliament can be contacted. The EU Regulation is being sponsored by the Environment, Public Health and Food Safety Committee. The Secretariat can be contacted at:
The Rapporteur is Glenis Willmott The proposed regulation can be downloaded here:

  • EMA Position paper on TMFs
    • Closing 29th April

 Next Meeting

  • 3rd June  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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