Summary of Changes in November 2018 Release

Summary of Changes in November 2018 Release

Table of Contents 3 4 5 - 7 5 6 7 8 - 21 22 - 32 Section Slide(s)
Summary of CPT Releases 3 Installation Instructions for November 2018 Release 4 What’s Included in the November 2018 Release 5 - 7 CPT Content Updates; CPT Library Updates 5 Improvements in CPT Technology; New Common Templates 6 CPT Fields Available for Export for Disclosure 7 November 2018 Release – CPT Content Updates 8 - 21 November 2018 Release – CPT Technology Improvements Legally approved Nov-2018

Summary of CPT Releases
Release Number Release Date Audience Template versions included Basic Word Tech-Enabled 1.0 August 2015 Member Companies CPT 2.0 December 2015 Public 3.0 June 2016 Member Companies, Public * May 2017 December 2017 November 2018 CPT, SAP, CSR Legally approved Nov-2018 * Release numbers no longer assigned beginning with May 2017 release

Installation Instructions for the November 2018 Release
For new users (no prior CPT edition installed) Please follow the CPT Installation Instructions document. For users updating to November 2018 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 Legally approved Nov-2018

What’s Included in the November 2018 Release?
CPT Content Updates Language updated to enable use in device and vaccine trials EU Clinical Trial Regulation analysis and alignment ICH E6 [R2] and E9 [R1] alignment More robust statistical analysis, including the use of Estimands in Objectives/Endpoint sections Updates based on FDA and EMA feedback CPT Library Updates Updates to Existing Participant Libraries - Healthy, Patient, Pediatrics New Therapeutic Area Libraries - CV-Safety, Vaccines NOTE: Comparison documents are available to view specific updates for CPT Core and all revised libraries. Legally approved Nov-2018

Improvements in the CPT Technology Enabled Edition Improved authoring functionality (allow co-authoring, support track-changes, support for variable text, improved management of intervention group and registry identifier tables) Improved accessibility to contraceptive related language from patient libraries Capability to store and manage CPT library files in a central location (ie, SharePoint) New Common Templates Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Legally approved Nov-2018

CPT Fields (Variables) Available for Export to Facilitate Disclosure to Trial Registries (options available to export for both clinicaltrials.gov and EudraCT requirements) Compound Number Protocol Number Study phase Protocol Title Protocol Short Title Acronym Approval Date Sponsor Name Sponsor Legal Address Regulatory Agency ID Regulatory Agency Number Intervention Groups and Duration Data Monitoring Committee Intervention Model Primary Purpose Study Phase Masking Participant and Study Completion Number of Participants Enrollment Target Number of Arms Arm Name 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 Study Rationale Objectives Primary Endpoints Primary Objectives Secondary Endpoints Secondary Objectives Tertiary Exploratory Endpoints Tertiary Study Design Overall Design Inclusion Criteria Age Inclusion Criteria Informed Consent Inclusion Criteria Sex Inclusion Criteria Type of Participant Inclusion Criteria Weight 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 Legally approved Nov-2018 *Variables do not appear in Template but are included in export with values populated

November 2018 Release – CPT Content updates
Changes to Terminology Alignment throughout CPT and libraries for the use of study intervention and participant Use of the following terms: Definitive discontinuation (replaces permanent discontinuation) Clinical Outcome Assessment [COA] (replaces Patient Reported Outcome [PRO]) Estimands added to Objectives/Endpoint table The user is cautioned to be cognizant of the use of words like ‘must’, ‘required’, and other similar terms as these may result in protocol deviations Effectiveness is used for Medical device studies whereas for drugs, efficacy is used. Template should be updated as appropriate For Medical Device protocols, AE terminology used in Appendix 7 aligns with the International Organization for Standardization (ISO) and ICH guidance, and thus must be included Legally approved Nov-2018

November 2018 Release – CPT Content updates
Changes in Formatting and Text Conventions Instructional Text modified to clarify: Suggested text may be deleted/modified as needed Flags for the start and end of common text can be removed automatically at the time of protocol finalization if the technology enabled CPT has been used or should be removed manually by the author Correction of ‘color’ formatting where required Change throughout for consistency in use of ‘e.g.’ and ‘i.e.’ Legally approved Nov-2018

November 2018 Release – CPT Content Updates
Level 1 and 2 Headings – Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 2.3 Benefit/Risk Assessment Changed section heading to include ‘Risk’ To facilitate compliance with the requirements of EU Clinical Trial Regulation Annex 1, Section D, 17d Section 8.9 Immunogenicity Assessments Previously Level 3 heading Feedback from Member Companies/Vaccines not to include under Biomarkers 8.10 [Health Economics] OR [Medical Resource Utilization and Health Economics] Previously Section 8.9 Moved as result of inclusion of new Level 2 heading for Immunogenicity Assessments 9.6 [Data Monitoring Committee (DMC) or other Review Board] Title amended and moved to Level 2 heading rather than subsection of Section 9.5 To enable use of section for internal and external committees. Does not always occur as part of Interim Analysis 10.7 Appendix 7: Medical Device Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) and Device Deficiencies: Definition and Procedures for Recording, Evaluating, Follow-up, and Reporting Title and section content amended to reflect definitions from ISO and ICH Guidance Input from Medical Devices working group to allow use of CPT for Medical Device studies without need for library Legally approved Nov-2018

Miscellaneous Updates – Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale Title Page (Compound): Modified from “Number” to “Number or Name” Accommodate devices and compounds with non-proprietary names as per ct.gov Title Page (Legal Registered Address): Added Instructional Text to include Manufacturer for device studies Required for Device studies Protocol Amendment Summary of Changes Table Instructional Text includes guidance for providing a clean version of the protocol, a track-changes version of the protocol, and a tabular listing detailing initial wording and amended or new wording for substantial amendments In response to feedback from EU countries that required to comply with EU-CTR requirements specified in Annex II, Section d., 5 1.1 Synopsis – Objectives and Endpoints Added Estimands to Endpoints in the Objectives and Endpoints table In response to ICH E9 (R1) changes 1.1 Synopsis – Overall Design Instructional Text updated to include “single or multicenter” Amended to facilitate re-use of wording from core Section 4.1 Overall design Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 1.1 Synopsis – Number of participants Updated Suggested Text clarifying definition of an enrolled participant Definition from ClinTrials.gov added to assist disclosure 1.3 Schedule of Activities Modified procedure names: “Past and current medical conditions” to “Current medical conditions” Added a procedure, “[Device deficiencies], if applicable” Past conditions should be covered in Medical History Added optional row to guide authors of Device study protocols 2.1 Study Rationale Updated Instructional Text for device studies CPT now adapted for use in device studies 2.3 Benefit/Risk Assessment Updated Instructional Text and Suggested Text for device studies. Suggested sub-headings added with instructional text 2.3.1 Risk Assessment – includes example table 2.3.2 Benefit Assessment 2.3.3 Overall Benefit: Risk Conclusion To facilitate compliance with EU Clinical Trial Regulation Annex 1, Section D, 17d: assess Risk/Benefit ratio and include rationale for specific inclusion/exclusion and withdrawal criteria. Table will facilitate HRA and IRB review Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 3. Objectives and Endpoints Added Estimands to Endpoints in the Objectives and Endpoints table Updated Instructional Text: Suggestion to include the time points for evaluation of endpoints Added guidance text for objectives Guidance text for use of estimands To address the inclusion of Estimands in the recently released ICH E9 (R1) 4.1 Overall Design Added Instructional Text throughout the section to provide details for the study design Alignment with Overall Design detail in Section 1.1 Synopsis 4.2. Scientific Rationale for Study Design Added Instructional Text to provide a scientific rationale that including a vulnerable study population (if applicable), provide justification for the gender and age allocation, justification of use of marketed product as AMP/NIMP Added to ensure compliance with added to address EU CTR Annex 1, Section D, 17d, 17j and 17e 4.2.1 Participant Input into Design New section added EU CTR Annex 1, Section D, 17e 4.3 Justification for Dose Added Instructional Text and Suggested Text related to device products Enables use of CPT for device studies Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 6.1 Study Interventions administered Modified the study intervention table for devices and added ‘USE’ row ‘Use’ field required for ct.gov disclosure 6.1.1 Medical Devices Added Instructional Text that this section is required for medical devices and can be deleted for non-device protocols. Modified suggested text regarding device deficiencies Added at request of Medical Devices working group 6.2 Preparation/Handling/Storage/ Accountability Added Instructional Text for device protocols 6.4 Study Intervention compliance Added Suggested Text to detail intervention compliance and document it Guide authors at request of Vaccine and Medical device working groups 6.6.1 Retreatment Criteria (if applicable) Added this section and Suggested Text (to be included when applicable) Added at request of Medical Devices working group (potential for all studies) 7.1 Discontinuation of Study Intervention Modified Common Text for permanent discontinuation (definitive discontinuation) of study intervention Added Instructional Text to insert text from participant libraries, when appropriate e.g. QTc Member Company feedback that guidance was not clear Legally approved Nov-2018

November 2018 Release - CPT Content Updates
Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 8. Study Assessments and Procedures Added Instructional Text for use of devices Added Instructional Text for the Clinical Outcome Assessment (COA) measures (encompassing Patient-reported outcome [PRO] measures, Clinician-reported outcome [ClinRO] measures and Observer-reported outcome [ObsRO]) measures and the Performance outcome (PerfO) measures Terminology changed to address FDA feedback and align with FDA/NIH template. Definitions added to assess authors Device information added at request of Device working group 8.3 Adverse Events and Serious Adverse Events Amended instructional text to cross reference new Level 3 heading Events of Special Interest. Added Common Text reference definitions for device-related safety events 8.3.8 Adverse Events of Special Interest Added a Level 3 section for Adverse Events of Special Interest Optional heading added with guidance in response to Member Company feedback 8.3.9 Medical Device Deficiencies Changed the entire section for Medical Device Incidents to Medical Device Deficiencies Updated Instructional and Suggested Text for all subsections Device information modified at request of Device working group to align with ISO and ICH guidance for Device studies Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 8.5 Pharmacokinetics Modified Suggested Text to state that the timing of sampling may be altered during the course of the study to ensure appropriate monitoring. Removed detailed text regarding sponsor process for addition of time points for study assessments. To allow flexibility for early phase studies to amend timepoints without including wording that may result in IRB rejections for later phase studies. 8.6 Pharmacodynamics Removed Suggested Text related to sample collection and handling Not applicable for many studies and duplicated in Biomarker section 8.8 Biomarkers Added Instructional Text to include the volume of fluid or sample amount required and to add any special instructions Removed suggested text regarding sample storage and subsections for RNA Transcriptome Research, RNA Expression Research of a Subset of RNA Species, Proteome Research, Metabolomic Research Information for site impacting participant should be included in protocol . Simplification of CPT by removal of details of specific biomarker analyses that can be added by each Member Company dependent on study requirements 8.9 Immunogenicity Assessment Moved from Section 8.8 Biomarkers to an independent Level 2 subsection Member Company and Vaccines working group feedback Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 8.10 [Health Economics] OR [Medical Resource Utilization and Health Economics] Modified Instructional Text to replace Patient Related Outcome (PRO) with the term Clinical Outcome Assessment (COA) FDA feedback on CPT and alignment with FDA/NIH template 9.1 Statistical Hypothesis Modified Instructional Text to state if no hypotheses are planned and include multiplicity control strategy (if any) FDA feedback and to assist authors 9.2 Sample Size Determination Modified Suggested Text to include enrolled participants (versus randomly assigned) Added the definition for enrolled participants to Suggested Text Definitions aligned with clintrials.gov 9.4 Statistical Analysis Modified Suggested Text to clarify information included in the Statistical Analysis Plan (SAP) Added subsection for General Considerations Removed the subsection for efficacy analysis and added separate subsections for Primary endpoint(s), Secondary endpoint(s), tertiary/exploratory endpoint(s) Input from Statistics working group in response to FDA comments and to align with SAP and CSR requirements Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 9.5 Interim Analysis Instructional text modified to suggest that interim analysis must be in accordance with ICH-E9 Removed references to the Data Safety Monitoring Board from the Instructional Text Input from Statistics working group in response to FDA comments and to align with SAP and CSR requirements 9.6 [Data Monitoring Committee (DMC) or Other Review Board] Moved to a separate Level 2 heading to encompass all review boards. Instructional text included that the Data Monitoring Committee (DMC)/Review Board procedures will be detailed in a charter in the appendix Member Company and Vaccines working group feedback that need to enable use of section for internal and external committees. Does not always occur as part of Interim Analysis Informed Consent Process Added Instructional text to include ethical concerns for the study (if any) and to Consider the key elements of the Informed Consent Process To comply with EU CTR Annex 1, Section D, 17z Data Protection Added common text that the participant will be required to give consent for their data to be used as described in the informed consent HRA feedback that additional wording needed to address EU GDPR Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale Study and Site Start and Closure Modified section heading from ‘Study and Site Closure’. Added Suggested Text for study start date and the first act of recruitment Added Common Text regarding sponsor responsibilities on premature termination/suspension of the study To comply with EU Clinical Trials Regulation No 536/2014 requirements (38) for definition of start of recruitment and ct.gov definition of study start. Common text added to assist authors 10.2 Appendix 2: Clinical Laboratory Tests Removed text suggesting, “All study-required laboratory assessments will be performed by a central laboratory, with the exception of XX” 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 Added Instructional text to use Appendix 7 for Medical Device studies Legally approved Nov-2018

Miscellaneous Updates - Core Template November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale 10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information Added Common Text specifying time range for spontaneous abortion or still birth in Female participants Clarification for authors 10.7 Appendix 7: Medical Device Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) and Device Deficiencies: Definition and Procedures for Recording, Evaluating, Follow-up, and Reporting Modified appendix heading and text to include Medical Device Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) and Device Deficiencies Added a flowchart for AE, ADE, SAE, SADE* determination flow chart *SADE is defined as an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event Input from Medical Devices working group to align with ISO and ICH guidance's for studies with Medical Devices Legally approved Nov-2018

Miscellaneous Updates –Library Templates November 2018 Section # and Name Description of Change from CPT Release Dec 2017 Brief Rationale Healthy Volunteer/Patient Section 5.1 Inclusion Criteria Formatting changes within Inclusion Criterion number 4. Sex Clarification to facilitate authors in selecting correct options Healthy Volunteer /Patient Section 5.2, Exclusion Criteria Criterion 21 split into two separate criteria Clarification of criterion to allow option to exclude participants enrolled or participated in other studies whilst allowing enrollment into the same study more than once Pediatric library Section 5.1 Inclusion Criteria and Appendix 4 Contraceptive Guidance and Collection of Pregnancy Information Section Suicidal Ideation and Behavior Risk Monitoring Additional guidance text added to Sex Criterion 2 Sex and Informed Consent Criterion Additional guidance wording added and suggested wording aligned with core template Greater clarification on contraceptive requirements to be considered for this population and on age categories for signing of informed consent (ICH E11) and sharing of information on pregnancy Guidance for authors on privacy considerations RA library Section 8.1 Efficacy Assessments Addition of definition of Simplified Disease Activity Index (SDAI) Included in endpoints but omitted from this section previously Legally approved Nov-2018

November 2018 Release – CPT Technology Improvements
The content controls for "Overall Design" in the CPT Synopsis section and the main body of the protocol shall be uniquely named as different data should be able to be entered into the 2 separate sections The Technology Enabled Edition (TEE) of the CPT shall support tracked changes in CPT The Technology Enabled Edition (TEE) of the CPT shall allow users the ability to store and manage library files at a central location rather than on a users local hard drive. Users shall also be able to access these files while working offline The Technology Enabled Edition (TEE) of the CPT shall have the capability for integrating company specific libraries The Technology Enabled Edition (TEE) of the CPT shall have improved authoring functionality, and will allow for co-authoring (co-authoring may be limited by the authoring environment ie. MsWORD version, WINDOWs version, or central location [eg. Sharepoint version]) Legally approved Nov-2018

The CPT Panel display 4 subsections to users: Libraries Instructional Text Additional Content (new) Preview Content Legally approved Nov-2018

The subsections in the CPT panel may be hidden/collapsed : Libraries Instructional Text Additional Content Preview Content Legally approved Nov-2018

Protocols written in a version before the last release in the Technology Enabled Edition (TEE) of the CPT can be opened in read only mode without forcing Microsoft Word to shut down The following message will be seen when a protocol in an earlier version is opened: Legally approved Nov-2018

A contraception language wizard will assists users in deciding on the options from the contraceptive decision tree (Pop out window) Users will have the choice to add the relevant content from the Participant libraries Text relevant for the selection will be seen in the instructional text Legally approved Nov-2018

The Technology Enabled Edition (TEE) of the CPT shall display tool tips for all the buttons on the CPT tab (see examples below) Legally approved Nov-2018

The Study Interventions Table "TYPE" cell of the Technology Enabled CPT, shall contain the choice of "other" and shall also accept additional free text after a selection is made Text can be changed Legally approved Nov-2018

The Technology Enabled Edition (TEE) of the CPT shall allow a user to add an additional row(s) of variables to the Agency ID table or an additional column(s) of variables to the Study Interventions table via the Add Variable Set button on the CPT tab Legally approved Nov-2018

The Technology Enabled Edition (TEE) of the Common Protocol Template (CPT) will have the ability to navigate to variable text Legally approved Nov-2018

The Technology Enabled Edition (TEE) of the CPT document shall have the capability of providing a preference when using the "Text Tools" menu. Users will be able to select the default option via the "About" button dialogue. The options are: (1) allow user to move to the next section of Example text after convert/delete function or (2) allow user to stay in the same section of Example text after convert/delete function Legally approved Nov-2018

The Technology Enabled Edition (TEE) of the CPT shall have a Managed Variable Section that will allow users to edit/add new variables for Use in the CPT. The managed variables section will walk the users through a wizard to edit/add the variables Legally approved Nov-2018

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Summary of Changes in November 2018 Release

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