History and Evolution of CPT Releases December 2017

History and Evolution of CPT Releases

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

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 December 2017 Legally approved 8-Apr-2017

Comparison Versions Available for Reference – December 2017 Release 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

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

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

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