1. History and Evolution of CPT Releases
November 2018

2. Moving Clinical Trials From Paper to Digital
Legally approved Nov-2018
Now let’s take a bird’s eye view of our CPT journey – helping to move clinical trials from paper to a digital platform.
Our initial two template releases were made in 2015, and established the Basic Word Edition and a robust Implementation Toolkit to enable adoption.
2016 saw Release 3 –and availability of a Technology-Enabled Edition of the template to complement the Basic Word Edition. We also introduced guidance for authoring of amendments using the CPT.
Release 4, in 2017, provided updates to the two CPT editions in alignment with the NIH-FDA template. Additional therapeutic libraries were also introduced , as well as some enhancements to the technology features. Importantly, the team also demonstrated proof-of-concept regarding the potential for CPT to drive automation of CRFs and traceability.
Later in 2017, a second CPT release, Release 5, enabled disclosure of many protocol elements to Clinicaltrials.gov and EudraCT, and provided 5 new therapeutic libraries.
2018 has been another busy year, as the CPT team has been focused on establishing a governance model to ensure sustainability of the template, and expanding opportunities for user and health authority engagement.
The team is now “heads down” in the final stages of preparation for a 4Q template release. The 2018 release will feature a number of additional capabilities as well as new common Statistical Analysis Plan and Clinical Study Report templates, to pave the way for automation and reuse of protocol content. In 2019 and beyond, we will continue to expand automation and reuse.

3. Alignment of CPT with NIH-FDA Template – May 2017
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
Legally approved Nov-2018

4. Summary of CPT Releases
Release Number
Release Date
Audience
Template versions included
Basic Word
Tech-Enabled
1.0
August 2015
Member Companies
CPT
2.0
December 2015
Public
3.0
June 2016
Member Companies, Public *
May 2017
December 2017
November 2018
CPT, SAP, CSR
Legally approved Nov-2018
* Release numbers no longer assigned beginning with May 2017 release

5. CPT Release and Version Identification Conventions
Releases
Beginning with the May 2017 Release, releases are referenced by year and month date (e.g., the December 2017 release). A list of all files and their version number is compiled and published with the release.
Versions
Versions are referenced by a 3 digit number at the end of the file name.
EXAMPLE FILE NAME: CPT_CoreBWE_V004.dotx
Each file is numbered independently.
Files are versioned only as a result of revision.
Note: There is a one time exception to move to the new version numbering convention in the May 2017 release.
A summary of changes from previous version is provided for every version of every file released. There is no distinction made between major and minor revisions.
Legally approved Nov-2018

6. Comparison Versions Available for Reference – November 2018 Release
NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-Dec2017-to-Nov2018.zip
Template Component
Versions Compared
CPT Core Backbone
V005 to V006
Healthy Volunteer Library
V004 to V005
Patient Library
Pediatric Library
V002 to V003
Alzheimer’s Library
Asthma Library
V003 to V004
Diabetes Library
Breast Cancer Library
V001 to V002
COPD Library
DKD Library
Prostate Cancer Library
RA Library
TQT Library
Legally approved Nov-2018

7. Comparison Versions Available for Reference – December 2017 Release
NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-May2017-to-Dec2017.zip
Template Component
Versions Compared
CPT Core Backbone
V004 to V005
Healthy Volunteer Library
V003 to V004
Patient Library
Pediatric Library
V001 to V002
Alzheimer’s Library
Legally approved Nov-2018

8. Comparison Versions Available for Reference – May 2017 Release
Template Component
Versions Compared
CPT Core Backbone
V3.1 to V004
Healthy Volunteer Library
V2.1 to V003
Patient Library
Asthma Library
Diabetes Library
Legally approved Nov-2018

9. Comparison Versions Available for Reference – June 2016 (R3.0) Release
Template Component
Versions Compared
CPT Core Backbone
V2.0 to V3.0
Healthy Volunteer Library
V2.0 to V2.1
Patient Library
Asthma Library
Diabetes Library
Legally approved Nov-2018

10. Thank you