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History and Evolution of CPT Releases

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

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  1. History and Evolution of CPT Releases November 2018

  2. Moving Clinical Trials From Paper to Digital

  3. 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

  4. Summary of CPT Releases * Release numbers no longer assigned beginning with May 2017 release

  5. 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.

  6. Comparison Versions Available for Reference – November 2018 Release NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-Dec2017-to-Nov2018.zip

  7. Comparison Versions Available for Reference – December 2017 Release NOTE: Comparison files for this release are in: CPT_ImplTK-Compare-May2017-to-Dec2017.zip

  8. Comparison Versions Available for Reference – May 2017 Release

  9. Comparison Versions Available for Reference – June 2016 (R3.0) Release

  10. Thank you

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