1. Common Protocol Template (CPT)
May 2017 Release Highlights

2. Table of Contents Section Slide(s) Summary of CPT Releases 3
Installation Instructions for May 2017 Release 4
CPT Release and Version Identification Conventions 5
What’s Included in the May 2017 Release 6
May 2017 Release – Content Updates
7 – 22
May 2017 Release – Technology Improvements

3. 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

4. Installation Instructions for the May 2017 Release
For new users (no prior CPT edition installed)
Please follow the CPT Installation Instructions document.
For users updating to May 2017 Release (prior CPT edition already installed)
Please uninstall the previous version and then follow the CPT Installation Instructions document.
Go to Control Panel>Programs and Features> and select the below 2 files to uninstall:
CPT Intelligent Content Management
CPT Library Management Add-In

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 October 2018 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. What’s Included in the May 2017 Release?
Content Updates
Alignment of CPT with NIH-FDA Protocol Template NIH = National Institutes of Health; FDA = Food and Drug Administration
Addition of designated fields to facilitate Trial Registration to CT.gov
Contraception language
Miscellaneous updates - Core Template
Existing Libraries
Participant: Healthy, Patient
Therapeutic Area: Asthma, Diabetes
New Participant Library: Pediatrics
New Therapeutic Area Libraries: Alzheimer’s Disease, QT
Technology Improvements
Improve instructional text pane
Improve library selection interface
Improve example text use/formatting
NOTE: Comparison documents are available to view specific updates for CPT Core and all libraries being revised.

7. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Rationale/Goal
Mutual desire to harmonize templates (CPT and NIH-FDA Protocol Template)
Acknowledged different audiences: NIH-FDA Protocol Template targeted at single- center and investigator led studies; CPT targeted at global multi-center studies.
Harmonizing templates will drive harmonization in resulting protocols regardless of template used
Alignment on all Level 1 headings, and most Level 2 headings
Both templates (CPT and NIH-FDA Protocol Template) to be maintained, modifications to each to achieve greatest harmonization
Updates Included
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

8. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Throughout the template
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
Use of the word “treatment”
now referred to as “intervention”

9. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
Title Page
Signature Page
Protocol Amendment Summary of Changes Table
Table of Contents
1 Synopsis
2 Schedule of Activities (SoA)
1 Protocol Summary
1.1 Synopsis
1.2 Schema
1.3 Schedule of Activities (SoA)
3 Introduction
3.1 Study Rationale
3.2 Background
3.3 Benefit/Risk Assessment
2 Introduction
2.1 Study Rationale
2.2 Background
2.3 Benefit/Risk Assessment
4 Objectives and Endpoints
3 Objectives and Endpoints

10. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
5 Study Design
5.1 Overall Design
5.2 Participant and Study Completion
5.3 End of Study Definition
5.4 Scientific Rationale for Study Design
5.5 Justification for Dose
4 Study Design
4.1 Overall Design
4.2 Scientific Rationale for Study Design
4.3 Justification for Dose
4.4 End of Study Definition
6 Study Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Lifestyle Restrictions
6.4 Screen Failures
5 Study Population
5.1 Inclusion Criteria
5.2 Exclusion Criteria
CPT 5.3 Lifestyle Considerations
CPT 5.4 Screen Failures
NIH 5.3 NIH Recruitment

11. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
7 Treatments
7.1 Study Treatment Administered
7.2 Dose Modification
7.3 Method of Treatment Assignment
7.4 Blinding
7.5 Preparation/Handling/Storage/Accountability
7.6 Treatment Compliance
7.7 Concomitant Therapy
7.8 Treatment after the End of the Study
6 Study Intervention
6.1 Study Intervention(s) Administered
6.2 Preparation/Handling/Storage/Accountability
6.3 Measures to Minimize Bias: Randomization and Blinding
6.4 Study Intervention Compliance
6.5 Concomitant Therapy
CPT 6.6 Dose Modification
CPT 6.7 Intervention after the End of the Study

12. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
8 Discontinuation/Withdrawal Criteria
8.1 Discontinuation of Study Treatment
8.2 Withdrawal from the Study
8.3 Lost to Follow Up
7 Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal
7.1 Discontinuation of Study Intervention
7.2 Participant Discontinuation/Withdrawal from the Study
7.3 Lost to Follow Up

13. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
9 Study Assessments and Procedures
9.1 Efficacy Assessments
9.2 Adverse Events
9.3 Treatment of Overdose
9.4 Safety Assessments
9.5 Pharmacokinetics
9.6 Pharmacodynamics
9.7 [Genetics]
9.8 Biomarkers
9.9 [Health Economics] OR [Medical Resource Utilization and Health Economics]
8 Study Assessments and Procedures
8.1 Efficacy Assessments
8.2 Safety Assessments
8.3 Adverse Events and Serious Adverse Events
CPT 8.4 Treatment of Overdose
CPT 8.5 Pharmacokinetics
CPT 8.6 Pharmacodynamics
CPT 8.7 [Genetics]
CPT 8.8 Biomarkers
CPT 8.9 [Health Economics] OR [Medical Resource Utilization and Health Economics]
NIH 8.4 Reporting of Unexpected Problems
NIH 8.5 Handling of Specimen

14. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
10 Statistical Considerations
9.1 Sample Size Determination
9.2 Populations for Analyses
9.3 Statistical Analyses
9 Statistical Considerations
9.1 Statistical Hypotheses
9.2 Sample Size Determination
9.3 Populations for Analyses
9.4 Statistical Analyses
9.5 Interim Analysis

15. May 2017 Release - Content Updates
Alignment of CPT with NIH-FDA Protocol Template
Updates Included – Section Numbers/Titles/Sequence
CPT Release 3.1
(Current Release)
Aligned CPT and NIH-FDA Protocol Template Headings (May 2017 Release)
11 References
12 Appendices
Appendix 1: Abbreviations and Trademarks
Appendix 2: Clinical Laboratory Tests
Appendix 3: Study Governance Considerations
Appendix 4: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting
Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information
Appendix 6: Genetics
Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Treatment Rechallenge Guidelines]
Appendix 8: Medical Device Incidents: Definition and Procedures for Recording, Evaluating, Follow-up, and Reporting
Appendix 9: Country-specific requirements
Appendix 10: Protocol Amendment History
10 Supporting Documentation and Operational Considerations
10.1 Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
CPT 10.2 Appendix 2: Clinical Laboratory Tests
CPT 10.3 Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting
CPT 10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information
CPT 10.5 Appendix 5: Genetics
CPT 10.6 Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Intervention Rechallenge Guidelines]
CPT 10.7 Appendix 7: Medical Device Incidents: Definition and Procedures for Recording, Evaluating, Follow-up, and Reporting
CPT 10.8 Appendix 8: Country-specific requirements
CPT 10.9 Appendix 9: Abbreviations
CPT Appendix 10: Protocol Amendment History

16. May 2017 Release - Content Updates
Addition of designated fields to facilitate Trial Registration to CT.gov
Rationale/Goal
Enable Registration of the Protocol – Trial Disclosure Form – original registration and updated once per amendment
No impact for Operational elements (e.g. #sites, start date, # enrolled) or Results Reporting aspects of Trial Registration
Ability to export registration data directly from the protocol
Updates Included
CPT captures protocol related data for disclosure fields per CDISC CTR standards
Updated variable names, new variables
Character limits on variables where required by CT.gov
Export of all captured variables in CDISC CTR-XML
Additional disclosure-related instructional text

17. May 2017 Release - Content Updates
Contraception Language
Rationale/Goal
To align the requirements with current guidance on contraception in clinical trials.
Updates Included
May 2017 Section # and Name
Description of Change from CPT Release 3.1
Brief Rationale
10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy – WOCBP (Women of Childbearing Potential)
Required use of contraception for females on HRT (hormone replacement therapy) or whose menopausal status is in doubt specifies non-estrogen hormonal contraception (previously hormonal contraception).
For women already receiving hormonal replacement with estrogen, additional estrogen-containing hormonal contraception may increase risks from high levels.
10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy – Male Participants
Changed placement of requirement for male participant to refrain from donating sperm.
To clarify that this requirement applies to all men rather than only those with female partners of childbearing potential.

18. May 2017 Release - Content Updates
Miscellaneous Updates - Core Template
Updates Included
May 2017 Section # and Name
Description of Change from CPT Release 3.1
Brief Rationale
Instructional Text (red); Example Text(green);
Variable Text (blue)
Various updates and additions throughout template
To aid in authoring the protocol
1.1 Synopsis – Objectives and Endpoints
Tertiary/Exploratory objectives and endpoints deleted from Synopsis (maintained in Section 3 of protocol)
To remove text not commonly used
1.1 Synopsis – Number of Participants
Deleted former section “ 5.2 Participant and Study Completion” including statements about numbers of participants screened and randomized
Number of Participants is now placed in section 9.2 Sample Size Determination, and also highlighted in 1.1 Synopsis
1.1 Synopsis – Data Monitoring Committee
Section added to allow author to specify Yes/No regarding use of a Data Monitoring Committee
To provide an indicator of this study design element, and easy retrieval for reporting to clinical trial registries

19. May 2017 Release - Content Updates
Miscellaneous Updates – Core Template
Updates Included
May 2017 Section # and Name
Description of Change from CPT Release 3.1
Brief Rationale
1.2 Schema
Separate section added for study schema
To provide a common, titled location
7.3 Lost To Follow Up – last bullet regarding unreachable participants
Deleted phrase “with a primary reason of lost to follow up”
To remove common text
8. Study Assessments and Procedures
Added common text to refer the reader to SoA for information about study procedures and timing
To provide cross-reference to information within the protocol
9.5.1 Data Monitoring Committee (DMC)
Added new Level 3 section

20. May 2017 Release - Content Updates
Existing Libraries – Healthy, Patient, Asthma, Diabetes
Updates Included
May 2017 Section # and Name
Description of Change from CPT Release 3.1
Brief Rationale
Instructional Text (red); Example Text(green);
Variable Text (blue)
Various updates and additions throughout libraries
To aid in authoring the protocol
Use of the word “treatment”
“Intervention” is now used throughout the libraries
To facilitate use of common text across broader range of study types
References to Level 1 and Level 2 headings in the template
Updated to reference new Level 1 and Level 2 headings
To facilitate alignment of library text to the core template sections
Acronyms/Abbreviations
Where missing, defined throughout the libraries
To aid comprehension
Patient Library – 5.2 Exclusion Criteria - #14
Update to liver/biliary disease exclusion
To clarify

21. May 2017 Release - Content Updates
Existing Libraries – Healthy, Patient, Asthma, Diabetes
Updates Included
May 2017 Section # and Name
Description of Change from CPT Release 3.1
Brief Rationale
Patient Library – 5.2 Exclusion Criteria - #24
Removed note regarding Hepatitis B core antibody (HBcAb) exclusion
To clarify
Patient Library – 5.2 Exclusion Criteria - #25
Added the word “only” to Hepatitis C antibody exclusion
Patient Library – 5.2 Section 7.1 – Discontinuation of study Intervention; and Appendix 6
Added definitions for test name and other abbreviations

22. May 2017 Release - Content Updates
New Therapeutic Area Libraries
Rationale/Goal
CDISC, C-Path and TransCelerate are championing the development of new standards for various therapeutic areas. As TAUGs are developed by CDISC and C-Path, the CPT strives to develop aligned therapeutic area libraries. Based on questionnaire responses from member companies, new therapeutic area libraries corresponding to the most votes were initially undertaken.

23. May 2017 Release – Technology Improvements
Automate Disclosure for CT.gov
Rationale/Goal
The CPT Template shall support automation to export variables for CT.gov
Updates Included
The following variables will be exported in the export functionality that currently exists in CPT. Additional variables will be included in the Fall 2017 release.
Protocol Title
Protocol Number
Short Title
Sponsor Name
Sponsor Legal Address
Number of Participants
Additional Reporting Information
Data Monitoring Committee
Inclusion Criteria: Age: Planned Minimum Age of Subjects
Inclusion Criteria: Age: Planned Maximum Age of Subjects
Inclusion Criteria: Sex: Sex of Participants
Exclusion Criteria: All content Controls

24. May 2017 Release – Technology Improvements
Improve Instructional Text Pane
Rationale/Goal
To improve functionality and ease of use of the right hand CPT Panel and Instructional Text Box.
Updates Included
The right hand CPT panel sections have been renamed to better represent their functionality (Libraries, Instructional Text, Additional Content).
The right hand CPT Instructional Text box can now be popped out and the wording increased/decreased/bolded for easier view when authoring the CPT Template.

25. May 2017 Release – Technology Improvements
Improve Library Selection Interface
Rationale/Goal
To assist authors when utilizing the template to select at least one of the two participant type libraries (e.g. Healthy Volunteer, or Patient)
Updates Included
When a user clicks on any content control in the template the Library Selection Window will open automatically for a user to select at least one of the participant type libraries (e.g. Healthy Volunteer, or Patient)
Users can drag and drop a library or utilize arrow buttons
The Participant Type library box now appears before Therapeutic Area

26. May 2017 Release – Technology Improvements
Improve Example Text Use/Formatting
Rationale/Goal
To search through Example Text but find instances where Example Text may not have been formatted correctly.
Updates Included
Now when searching through Example Text, a prompt will appear letting users know if there is an instance where Example Text has been formatted incorrectly and will allow users to correct it.

27. THANK YOU