1 DIA SIAC TMF Reference Model Lisa Mulcahy Karen Roy

2 Agenda Welcome and Introduction The Charter The Deliverables Who are we? Who else do we Need? Our First Goal Our Formal Output Three Key Questions Next Steps/What we need from YOU! Upcoming Activities

3 The Charter Why we need this group? What will our challenges be? What are we going to cover? What are we NOT going to cover? What are we going to deliver? And by when? (see next slide!) Who should be involved?

4 The Deliverables and By When Finalize the Charter By end of April? Submission of abstract to EU EDM Conference (Vienna) Categorize the TMF into zones and define the content list of trial master file documents within these zones. By end of August? Integrate the TMF into EDM reference Model for content and associated metadata By end of November? EU EDM Conference in beginning of December Develop a parking lot for 2010 Goals and Objectives

5 Who Are We? Astellas, CSC, Elan, Consultant, Clinilabs, Safe BioPharm Association, Actelion, Novartis, Phlexglobal, i3Research, Massachusetts General Hospital, Talecris, Lundbeck, Spectrum, Daiichi-Sankyo, Sterling Bio, NextDocs, Centocor, Shire, Astellas, CRIX International Denmark, Switzerland, UK, USA Clinical, clinical document management, business development, regulatory operations, regulatory, compliance, archiving,

6 Who Do We Still Need? What other functional areas? DM, Statistics, QA? Other DIA SIACs Other Associations – QA, GCP, Clinical, Archiving, Data Management Regulatory Agencies – US & Europe Stakeholders and Contributors

7 What is Our First Goal? To break the TMF down into manageable zones To allocate the zones to ‘zone leads’ To start to identify documents within each zone

8 Format Output? Reference Model - Clinical Domain

9 Three Key Questions Which other groups are stakeholders or contributors to this reference model? Which other functions should be included? How would you break the TMF into zones or sections? Questionnaire for completion to be circulated

10 What We Need From You? 1.Send comments on charter to Karen and Lisa by 27March 2.If you are not a member of DIA and want to continue on this initiative, you need to join the DIA. 3.If you are not a Document and Records Management (DRM) SIAC member you need to join the DIA DRM SIAC. Our communications and project documents will be stored in the DRM SIAC WebOffice. 4.Check out the DRM SIAC WebOffice space. 5.We want to collate as many different types of examples of of TMF content as possible. As long as they are allowed to be shared, please place these documents in the DRM SIAC WebOffice folder in the Documents tab: TMF Ref Model/TMF Content Examples. Please ensure the files made as anonymous as possible. 6.Complete Karen’s questionnaire!

11 Upcoming Activities Minutes from this meeting will be placed in WebOffice by 30MAR09. –DRM SIAC TMF Ref Model team members alerted by of placement (so please join the SIAC!) Next meeting will be held in 2 weeks, on 6APR09 at 11A EDT. –Our meetings from then forward will occur every 3weeks (April 27 th, May 18 th, June 8 th, …) –Meetings request will come from Michael McNair (DIA Volunteer Coordinator) through the DRM SIAC WebOffice