Interested in developing an eTMF solution? Check out details of our eTMF workshop.

1. eTMF TutorialMigrating from Paper Trial Master Files to Electronic Your Tutors: EldinRammell, RAMMELL Consulting Ltd Karen Roy, Phlexglobal Ltd © Phlexglobal Ltd / Rammell Consulting Ltd.

2. Scope This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as “what is the trial master file”, this interactive session will provide guidance in a wide range of related aspects, including: What the regulations say about eTMFs How documents should be filed in an eTMF Metadata and naming conventions Acceptable document formats How eTMFs can be reviewed by end-users, auditors & inspectors How eTMFs can support global clinical trials How to populate and maintain eTMFs Validation requirements for eTMFs Using e-signatures with eTMFs © Phlexglobal Ltd / Rammell Consulting Ltd.

3. Format The one-day tutorial will be run in-house on your premises or at a convenient off-site location. The interactive tutorial takes the form of a combination of classroom-style instruction, discussions and group activities. The day typically begins at 9:00 am and concludes around 5:00 pm. The material is suitable for a wide range of participants including: Records managers Clinical trial administrators/assistants Clinical team members, including monitors, data managers, medical writers, biostatisticians Technology professionals Clinical development managers © Phlexglobal Ltd / Rammell Consulting Ltd.

4. Objectives At the conclusion of the tutorial, participants should be able to: Implement practical project planning Recognise the principal regulatory requirements Understand the different approaches to eTMF design Develop useful user requirements for an eTMF Recognise the impact of an eTMF on trial-related processes Evaluate potential eTMF solutions © Phlexglobal Ltd / Rammell Consulting Ltd.

5. Tutors Eldin Rammell Over 20 years pharmaceutical experience as a records manager Experience with a range of document management technologies Consultancy experience includes small biopharmaceutical to top-10 pharmaceutical and CRO Former Chair of European GCP Records Managers Association Karen Roy 19 years experience in Clinical Trial Management & Support Managed large CRO Clinical Department across Europe Successfully started EDC Support division within a CRO Leading Phlexglobal’s eTMF initiatives Chair of DIA TMF Reference Model © Phlexglobal Ltd / Rammell Consulting Ltd.

6. Cost Each one-day tutorial delivered costs £4,750 / €5,300. Additional costs: Travel time per tutor Travel (e.g. flights, accommodation, subsistence costs) charged at cost Meeting room costs (if held at an off-site location) From time to time this tutorial will also be run as an open event at a cost of £800/€895 per delegate. Please contact us to obtain details of the next scheduled event. © Phlexglobal Ltd / Rammell Consulting Ltd.

7. Further details For more information or to arrange a tutorial for your company, please contact: Eldin Rammell t. +44 (0)844 8844926 or Karen Roy t. +44 (0)1494 720282 © Phlexglobal Ltd / Rammell Consulting Ltd.