This deck provides an overview on the history and evolution of CPT releases.

1. December 2017
History and Evolution of
CPT Releases

2. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
History and Evolution of CPT Releases

3. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
Rationale/Goal
Mutual desire to harmonize CPT and
NIH-FDA templates
– Acknowledged different audiences: NIH-
FDA template targeted at single-center
and investigator led studies; CPT targeted
at multi-center studies.
– Harmonizing templates will drive
harmonization in resulting protocols
regardless of template used
Both CPT and NIH-FDA templates to be
maintained, modifications made to each
to achieve greatest harmonization
Updates Included
Alignment on all Level 1 headings, and
most Level 2 headings
Revised order/placement of several
sections
– Where different Level 2 headings are
required, they are placed after the
common Level 2 headings.
Combined several sections
Harmonized terminology where
applicable
Alignment of CPT with NIH-FDA Template – May 2017

4. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
Summary of CPT Releases
Intended Audience Template versions included
Release
Number Release Date
Member
Companies Public Basic Word Tech-Enabled
1.0 August 2015
2.0 December 2015
3.0 June 2016
Release
Number no
longer being
assigned
May 2017
Release
Number no
longer being
assigned
December 2017

5. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
Comparison Versions Available for Reference –
December 2017 Release
5
Template Component Versions Compared
CPT Core Backbone V004 to V005
Healthy Volunteer Library V003 to V004
Patient Library V003 to V004
Pediatric Library V001 to V002
Alzheimer’s Library V001 to V002

6. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
Comparison Versions Available for Reference –
May 2017 Release
6
Template Component Versions Compared
CPT Core Backbone V3.1 to V004
Healthy Volunteer Library V2.1 to V003
Patient Library V2.1 to V003
Asthma Library V2.1 to V003
Diabetes Library V2.1 to V003

7. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
Comparison Versions Available for Reference –
June 2016 (R3.0) Release
7
Template Component Versions Compared
CPT Core Backbone V2.0 to V3.0
Healthy Volunteer Library V2.0 to V2.1
Patient Library V2.0 to V2.1
Asthma Library V2.0 to V2.1
Diabetes Library V2.0 to V2.1

8. Thank you