DIA SIAC TMF Reference Model Lisa Mulcahy Karen Roy Inaugural Meeting 23MAR2009

The Charter Why we need this group? What will our challenges be? What are we going to deliver? And by when? Who should be involved? 2

Charter: What is the TMF? The Trial Master File (TMF) contains those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. (ICH Guideline for Good Clinical Practice, E 6, Chapter 8).

Charter: Why We Need This All companies running clinical trials in the pharmaceutical/biotech industry maintain a TMF for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs. There exists no comprehensive common model for managing TMF documents. Many functions and vendors contribute to a TMF, each with their own interpretation and processes and oversight of the content on an ongoing basis is usually not one person’s or function’s responsibility.

Charter: The Challenges (1) Even though regulatory guidance exists such as ICH section 6, it addresses only a sub-set TMF documents. Documentation requirements for the set-up and maintenance of quality systems, electronic systems, safety monitoring, and proof of an adequate and well-controlled trial, to name a few, are in different parts of different regulations, for different countries or regions. A single, unified interpretation of the regulations by our project team, by our stakeholders, by Regulatory Agencies, and by the pharmaceutical industry will be some of our biggest hurdles we will need to overcome.

Charter: The Challenges (2) It is also paramount include opinions from Regulatory Agencies and other defining bodies who could either be contributors or stakeholders in standard TMF taxonomy and metadata. The TMF has a wide range of contributors and stakeholders, crossing over many DIA SIACs, as well as other Industry organizations e.g. QA, GCP, archiving, data management etc. It is imperative to get a wide-reaching input into this SIAC. The main challenge we are facing is the participation and adherence of the industry itself.

Charter: Scope With respect to the Content domain, the working group shall consider the full TMF with all applicable functional areas involved in clinical research and will not include the Preclinical, Non-clinical, and Chemical, Manufacturing & Controls functional areas.

Charter: 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 8

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, 9

Who Do We Still Need? What other functional areas? DM, Statistics, MW, QA? Other DIA SIACs Other Associations – QA, GCP, Clinical, Archiving, Data Management Regulatory Agencies – US & Europe Stakeholders and Contributors 10

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 11

Reference Model - Clinical Domain Format Output? Reference Model - Clinical Domain

Upcoming Activities Next meeting will be held in 2 weeks, on 6APR09 at 11A EDT. Our meetings from then forward will occur every 3weeks (April 27th, May 18th, June 8th, …) Meetings request will come from Michael McNair (DIA Volunteer Coordinator) through the DRM SIAC WebOffice