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?
· 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
· 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
· 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)
· 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)
· 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
· 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
- Next Meeting – to be decided
- 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!
- 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.