CPT Releases Moving Clinical Trials From Paper to Digital RationaleGoal Mutual desire to harmonize CPT and NIHFDA templates Acknowledged different audiences NIHFDA template targeted at singlecenter and investigator led studies CPT targeted at multicenter studies ID: 734813
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Slide1
November 2018
History and Evolution of
CPT ReleasesSlide2
Moving Clinical Trials From Paper to DigitalSlide3
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 IncludedAlignment on all Level 1 headings, and most Level 2 headingsRevised order/placement of several sectionsWhere different Level 2 headings are required, they are placed after the common Level 2 headings.Combined several sectionsHarmonized terminology where applicable
Alignment of CPT with NIH-FDA Template – May 2017Slide4
Summary of CPT Releases
Release Number
Release Date
Audience
Template versions included
Basic Word
Tech-Enabled
1.0
August 2015Member CompaniesCPTCPT2.0December 2015PublicCPT3.0June 2016Member Companies, PublicCPTCPT*May 2017Member Companies, PublicCPTCPT*December 2017Member Companies, PublicCPTCPT*November 2018PublicCPT, SAP, CSRCPTMember CompaniesCPT, SAP, CSRCPT, SAP, CSR
* Release numbers no longer assigned beginning with May 2017 releaseSlide5
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.VersionsVersions are referenced by a 3 digit number at the end of the file name. EXAMPLE FILE NAME: CPT_CoreBWE_V004.dotxEach 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.Slide6
Comparison Versions Available for Reference –
November 2018
Release
6
Template ComponentVersions ComparedCPT Core Backbone
V005 to V006Healthy Volunteer LibraryV004 to V005Patient LibraryV004 to V005Pediatric LibraryV002 to V003Alzheimer’s LibraryV002 to V003Asthma Library
V003 to V004
Diabetes Library
V003 to V004Breast Cancer LibraryV001 to V002COPD LibraryV001 to V002DKD LibraryV001 to V002Prostate Cancer LibraryV001 to V002RA LibraryV001 to V002TQT LibraryV001 to V002NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-Dec2017-to-Nov2018.zipSlide7
Comparison Versions Available for Reference –
December 2017 Release
7
Template Component
Versions ComparedCPT Core BackboneV004 to V005
Healthy Volunteer LibraryV003 to V004Patient LibraryV003 to V004Pediatric LibraryV001 to V002Alzheimer’s LibraryV001 to V002NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-May2017-to-Dec2017.zipSlide8
Comparison Versions Available for Reference –
May 2017 Release
8
Template Component
Versions ComparedCPT Core BackboneV3.1 to V004
Healthy Volunteer LibraryV2.1 to V003Patient LibraryV2.1 to V003Asthma LibraryV2.1 to V003Diabetes LibraryV2.1 to V003Slide9
Comparison Versions Available for Reference –
June 2016 (R3.0) Release
9
Template Component
Versions ComparedCPT Core BackboneV2.0 to V3.0
Healthy Volunteer LibraryV2.0 to V2.1Patient LibraryV2.0 to V2.1Asthma LibraryV2.0 to V2.1Diabetes LibraryV2.0 to V2.1Slide10
Thank you