History and Evolution of CPT Releases November 2018

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.

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

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

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

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

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

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

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

Thank you