Summary of Changes in CPT December 2017 Release

Summary of Changes in CPT December 2017 Release

Table of Contents Section Slide(s) Summary of CPT Releases 3
Installation Instructions for December 2017 Release 4 What’s Included in the December 2017 Release 5 - 6 December 2017 Release – Content Updates 7 – 22 December 2017 Release – Technology Improvements

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

Installation Instructions for the December 2017 Release
For new users (no prior CPT edition installed) Please follow the CPT Installation Instructions document. For users updating to December 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 Also, be sure to delete the previous version of the template itself

What’s Included in the December 2017 Release?
Content Updates Additional fields to facilitate capture of disclosure information for trial registries (e.g. clinicaltrials.gov, EudraCT) Contraception and pregnancy testing text updates Miscellaneous updates within the core template Updates to existing libraries Participant: Healthy, Patient, Pediatrics Therapeutic Area: Alzheimer’s New Therapeutic Area Libraries Diabetic Kidney Disease, COPD, Rheumatoid Arthritis, Breast Cancer, Prostate Cancer NOTE: Comparison documents are available to view specific updates for CPT Core and all libraries being revised.

What’s Included in the December 2017 Release?
Improvements in the Technology Enabled Edition Automated capture of disclosure content for ClinicalTrials.gov Enhanced export capabilities include exports for ClinicalTrials.gov, export of protocol content, and custom exports Ability to edit instructional text Instructions added in the Additional Content Section of the CPT panel Improve use of formatted text in libraries New work around for Mac iOS operating system Objective and Endpoint sync improvement

December 2017 Release - Content Updates
Complete list of CPT Fields (Variables) Available for Export to Facilitate Disclosure to Trial Registries (Fields in Orange font are new/updated for December 2017 Release) Compound Number Protocol Number Protocol Title Protocol Short Title Acronym Approval Date Sponsor Name Sponsor Legal Address Agency ID Regulatory Agency Number Data Monitoring Committee Intervention Model Primary Purpose Study Phase Masking Number of Participants Enrollment Target Planned Number of Arms Arm Name Study Intervention Name Intervention Type IMP and NIMP Sourcing Packaging and Labeling Current Former Names Aliases Dosage Formulation Route of Administration Dosage Level Unit Dose Strength Primary Objective(s) Primary Endpoint(s) Secondary Objective(s) Secondary Endpoint(s) Tertiary Objective(s) Tertiary Endpoint(s) Sex of Participants Planned Minimum Age of Subjects Planned Maximum Age of Subjects Exclusion Criteria Medical Conditions Exclusion Criteria Prior Concomitant Therapy Exclusion Criteria Prior Concurrent Clinical Study Experience Exclusion Criteria Diagnostic Assessment Exclusion Criteria Other *Sponsor Status = Commercial *Trial Type = Interventional *Responsible Party = Sponsor *Healthy Volunteer = HLTSUBJ1 *Variables do not appear in Template but are included in export with values populated

Contraception and Pregnancy Testing Rationale/Goal To provide additional clarity around acceptable contraceptive / barrier methods and pregnancy testing requirements based upon the risk of the interventions included in the study To consolidate all entry requirements into one section To consolidate pregnancy testing requirements during participation into one section Updates Included Decision Tree approach aligned with Clinical Trial Facilitation Group (CTFG) Recommendations and accompanying instructional text Each outcome is aligned with corresponding template text options found in Sections 5.1, Section Appendix 2, Clinical Laboratory Tests, and Section Appendix 4 Contraceptive and Barrier Guidance and Collection of Pregnancy Information. Appendix content pertaining to entry criteria and pregnancy testing during study participation was consolidated into Section 5.1 and Appendix 2. Instructional text and common text has been deleted from the Core Template, and is now found in the Participant Libraries (Healthy Volunteer, Patient, Pediatrics) and is to be inserted as applicable into Section 5.1 and Section Appendix 2.

Contraception and Pregnancy Testing Decision Tree Approach aligned with unique text options

Miscellaneous Updates – Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale Title Page Added Study Phase selections and definitions. Selections: NA, Early Phase 1, Phase 2, Phase 1/Phase 2, Phase 2, Phase 2/Phase 3, Phase 3, Phase 4 To facilitate disclosure to trial registries. Update aligned with FDA review feedback. Added Acronym or abbreviation used publically to identify the trial To facilitate disclosure to trial registries Added Regulatory Agency identifying number selections and instructional text. Selections: IND, EudraCT, NCT, WHO, Other 1.1 Synopsis - Rationale Updated instructional text to indicate that this description is to be taken from main body of the protocol To increase re-use of text across protocol sections 1.1 Synopsis – Disclosure Statement Added section and instructional text to include a one sentence statement to describe overall study design

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 1.1 Synopsis – Interventional Model Added section and definitions to describe study design interventional model. Selections: Single group, Parallel, Cross-Over, Factorial, Sequential To facilitate disclosure to trial registries 1.1 Synopsis – Primary Purpose Added section and definitions to describe primary purpose of the study. Selections: Treatment, Prevention, Diagnostic, Supportive Care, Screening, Health Services Research, Basic Science, Device Feasibility, Other 1.1 Synopsis – Number of Arms Added section and instructional text to define number of arms in the study 1.1 Synopsis – Masking Added section to define intervention masking. Selections: No Masking, Participant, Care Provider, Investigator, Outcomes Assessor 1.1 Synopsis – Data Monitoring Committee Clarified location of variable for use of an independent Data Monitoring Committee. Selections: Yes, No

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 1.3 Schedule of Activities Added column for “E/D” visit and definition (Early Discontinuation) in the Notes column To provide for a standard approach to displaying E/D visit procedures. Update aligned with FDA review feedback. 3. Objectives and Endpoints Added instructional text regarding trials designed to establish efficacy To aid in authoring the protocol. Update aligned with FDA review feedback. 4.2 Scientific Rationale for Study Design Added instructional text regarding primary endpoints 5.1 Inclusion Criteria - Sex - 4. Deleted Instructional text and standard criterion text, which is now located in the Participant Libraries (Healthy Volunteer, Patient, Pediatric) To present contraception and pregnancy aspects in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations 6.1 Study Intervention(s) Administered Added instructional text for completion of the Example table. Revised organization and content of the table To facilitate disclosure to trial registries

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 6.1.1 Medical Devices Added instructional text regarding diagnostic tests Added at the request of the FDA/NIH to align with the advice provided by CDRH (Center for Devices and Radiological Health) 6.4 Study Intervention Compliance Added Common Text regarding assessment of compliance To aid in authoring the protocol. Update aligned with FDA review feedback. 6.5 Concomitant Therapy Added Instructional Text regarding concomitant interventions that may affect critical outcome measures 6.5.1 Rescue Medicine Added Instructional Text regarding endpoint assessments 7.1 Discontinuation of Study Intervention Added Suggested Text regarding circumstances where participants may continue to be followed despite discontinuation of study intervention

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 7.2 Participant Discontinuation/ Withdrawal from Study Added and reorganized Common Text regarding discontinuation/withdrawal criteria To aid in authoring the protocol. Update aligned with FDA review feedback. 8. Study Assessments and Procedures Added instructional text to specify how unscheduled visits are handled and documented. To aid in authoring the protocol. Update aligned with FDA review feedback. 8.2.5 Suicidal Ideation and Behavior Risk Monitoring Revised section title. Revised and added Instructional Text, Example Text and Suggested Text To align more accurately with the assessments to be included here which relate not only to Suicidality but also behavioral changes. The language was simplified to make it clearer which option should be included 8.3.2 Method of Detecting AEs and SAEs Reorganized Common Text presented in this section To improve clarity and placement. Update aligned with FDA review feedback.

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 8.3.4 Regulatory Reporting Requirements for SAEs Added Instructional Text regarding handling situations where SAEs are also efficacy endpoints Added at the request of the FDA/NIH and to align with the advice provided within 21 CFR , FDA Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics and FDA Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies 9.1 Statistical Hypotheses Added Instructional Text regarding content of this section To aid in authoring the protocol. Update aligned with FDA review feedback. 9.4.1 Efficacy Analyses Added Instructional Text regarding content of this section regarding sub-groups of interest. 9.5.1 Data Monitoring Committee To aid in authoring the protocol. Update aligned with FDA review feedback.

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 10.1 Appendix 1: Regulatory, Ethical, and Study Oversight Considerations – Data Quality Assurance Added Common Text regarding monitoring details and actions delegated To aid in authoring the protocol. Update aligned with ICH E6 (R2). 10.2 Appendix 2: Clinical Laboratory Tests Added Instructional Text regarding pregnancy testing To present pregnancy testing information in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations 10.3 Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting – Reporting of SAEs Revised description of use of paper SAE data collection tool to ensure reporting of events within 24 hours To improve clarity of reporting timeframe

Miscellaneous Updates - Core Template Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information – Definitions Added Instructional Text and Common Text regarding definition of Women of Childbearing Potential (WOCBP) To present pregnancy testing information in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations 10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information – Contraception Guidance Deleted Instructional text and Common Text, which is now located in the Participant Libraries (Healthy Volunteer, Patient, Pediatric)

Existing Libraries - Participant Types: Healthy Volunteer, Patient Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale Healthy Volunteer and Patient Libraries 5.1 Inclusion Criteria – Sex - 4. Added Instructional text and Common text, previously located in the Core Template Section 5.1 To present contraception and pregnancy aspects in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations Healthy Volunteer and Patient Libraries Appendix 2: Clinical Laboratory Tests Added Instructional Text and Common Text regarding pregnancy testing To present pregnancy testing information in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations Healthy Volunteer and Patient Libraries Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information – Contraception Guidance Added Instructional text and Common text, which was previously located in the Core Template Section Appendix 4

Existing Libraries - Participant Types: Healthy Volunteer, Patient Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale Healthy Volunteer and Patient Libraries Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Intervention Rechallenge Guidelines] Added INR to Liver Chemistry panel in Common Text Additional monitoring is common to ensure return of INR to baseline level

Existing Libraries - Participant Types: Pediatric Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale Pediatric Library 5.1 Inclusion Criteria – Sex - 2. Deleted Instructional Text and Common Text. Added Instructional text to refer the author to content in the relevant Participant library (Healthy Volunteer or Patient) To present contraception and pregnancy aspects in a clearer and more consolidated manner, and aligned with Clinical Trial Facilitation Group (CTFG) recommendations

Existing Libraries - Therapeutic Area: Alzheimer’s Updates Included December 2017 Section # and Name Description of Change from CPT Release May 2017 Brief Rationale 1.3 Schedule of Activities (SOA) Added Instructional Text regarding activities/assessments to be considered for inclusion in study design To aid in authoring the protocol 11. References Reordered list of references To align with citations within Section 1.3

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. Updates Included The following libraries have been added: Diabetic Kidney Disease COPD Rheumatoid Arthritis Breast Cancer Prostate Cancer

December 2017 Release – Technology Improvements
Automate capture for disclosure to ClinicalTrials.gov and EudraCT, export of disclosure variables, protocol content and custom exports Rationale/Goal The CPT Template shall support automation to export variables for ClinicalTrials.gov, EudraCT, and allow for content from the protocol to be exported. Updates Included 47 variables are available for export. Predefined variable sets are available to support ClinicalTrials.gov and EudraCT exports Custom variable and protocol content exports can be created. Information is exported in both XML and Excel formats.

Ability to Edit Instructional Text Rationale/Goal Companies will be able to edit the Instructional text in the right hand CPT Panel in the template and then share new template with other resources Companies would be responsible for maintaining customization of instructional text. Impact: Changes made in the Technology Enabled Edition should be made in the Basic Word Edition as well. Release maintenance Plan: Companies will need to plan customization updates across releases

Instructions added in the Additional Content Section of the CPT panel Rationale/Goal To assist authors when utilizing the template to insert available content from a library or view instructional text from a library. Updates Included A user will now see the below instructions in the additional content section of the CPT Panel.

Improve use of Formatted text in Libraries Rationale/Goal To allow users to view/insert diagrams/tables from CPT libraries into the Template Updates Included Users will now be able to insert formatted text into the template from a library. Previously formatted text replaced content existing in a protocol Additionally, users can now view in certain sections, formatted instructional text from a library. This applies to the contraceptive decision tree diagram that appears in the healthy volunteer and patient libraries.

The technology enabled CPT is currently incompatible with the Mac IOS operating System but a new work around has been discovered. Rationale/Goal Desire to find alternative solution to allow users in the MAC iOS operating system utilize the technology enabled edition of CPT Updates Included A work around has been discovered which involves establishing a virtual Windows environment on the Mac Multiple options for that environment exist Temporary Virtual Windows environment created by a software application (e.g. Parallels Desktop) Partitioned hard drive formatted for Windows

Objective and Endpoint Sync Improvement Rationale/Goal Users shall have a visible cue when Objectives and Endpoints have been edited but not synced in the CPT Template Updates Included An icon will appear in the Additional Content Section when Objectives and endpoints are no longer in sync.

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Summary of Changes in CPT December 2017 Release

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