2. Introducing the Common Protocol Template

3. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 2 TransCelerate and the Common Protocol Template Initiative 2 17 member companies participated in the development of the Common Protocol Template Stakeholder Input

4. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 3 The Model for the Common Protocol Template Libraries Core Protocol Backbone Common Level 1 & 2 Headings Common text Used across all phases Focus on investigators Healthy Volunteer Patient Asthma Diabetes Appendices Non-study specific info, items triggered by event Implementation materials in Toolkit Core is streamlined and focused on site needs Proposed Appendices to apply as applicable Libraries group and store content which is used to populate the template Endpoint Definitions developed for asthma and diabetes A sustainable Governance Model is currently in development Common Protocol Template and Guidance Governance Model

5. THANK YOU