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History and Evolution of CPT Releases
December 2017
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History and Evolution of CPT Releases
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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
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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
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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
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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
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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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