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History and Evolution of CPT Releases. November 2018. Moving Clinical Trials From Paper to Digital. Alignment of CPT with NIH-FDA Template – May 2017. Updates Included Alignment on all Level 1 headings, and most Level 2 headings Revised order/placement of several sections
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History and Evolution of CPT Releases November 2018
Alignment of CPT with NIH-FDA Template – May 2017 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 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
Summary of CPT Releases * 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.
Comparison Versions Available for Reference – November 2018 Release NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-Dec2017-to-Nov2018.zip
Comparison Versions Available for Reference – December 2017 Release NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-May2017-to-Dec2017.zip
Comparison Versions Available for Reference – May 2017 Release
Comparison Versions Available for Reference – June 2016 (R3.0) Release