Meeting Minutes – 15th April 2013

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

 DIA DRM SIAC

  • 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 http://www.cbinet.com/conference/pc13140
  • 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:  https://www.surveymonkey.com/s/YLL78Z5

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:

envi-secretariat@europarl.europa.eu

The Rapporteur is Glenis Willmott glenis.willmott@europarl.europa.eu. The proposed regulation can be downloaded here:

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-504.236%2b01%2bDOC%2bPDF%2bV0%2f%2fEN

  • 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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Highlights of the 2012 Metrics Survey

An overview of the 2012 metrics survey has recently been made available.

The data indicates a significant growth in the number of organizations transitioning to eTMF.  32% of survey respondents maintain inspectable TMF’s in paper, down from 50% in the corresponding 2010 survey.  While there is only a modest increase in the number of respondents maintaining inspectable electronic TMFs (8%), the increase in the number of respondents maintaining a combination of paper and electronic was significant – 48% in 2012, compared to just 27% in 2010, indicating a continuing transition to eTMF in the industry.  The data on the current status of eTMFs in the industry also supports a trend to implementing eTMFs.  The 2012 survey reveals that 28% of respondents are currently using an eTMF, and 57% are in the process of planning, building or evaluating eTMF.  (In 2010, only 45% of respondents reported active building or evaluating of an eTMF.) Meanwhile, only 3% of respondents said they are not considering eTMF.

Adoption of the TMF Reference Model is also changing the landscape of trial master file management, especially for new trials just being launched.  Most respondents working with the reference model have updated their SOPs, guidance documents, and file structures to align with industry best practice.  Implementation of the TMF RM and alignment on SOPs and guidance documents may significantly ease the administrative burden in regulatory inspections, industry partnerships, collaboration between sponsors and CROs or acquisitions.

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:

DIA DRM SIAC

    • 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?

http://www.exlpharma.com/TMF

·         CBI Clintech in March USA

http://www.cbinet.com/conference/pc13077

·         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.