May2016 Common Protocol Template CPT Table of Contents Section Slide s Summary of CPT Releases 3 Installation Instructions for Release 3 4 Primary Features of the TechEnabled Edition ID: 583047
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Slide1
Release 3 HighlightsMay-2016
Common Protocol Template (CPT
)Slide2
Table of Contents
Section
Slide
(s)
Summary
of CPT Releases
3
Installation Instructions
for Release 3
4
Primary Features of
the Tech-Enabled Edition
5-10
Release 3 - Functionality Updates to Tech-Enabled
Edition
11-20
Release 3
-
Amendment Process
21
Release 3 - Content Updates
22-37Slide3
Summary of CPT Releases
Intended Audience
Template editions included
Release Number
Release Date
Member CompaniesPublicBasic WordTech-Enabled1.0Aug-20152.0Dec-20153.0June-20164.0Planned 4Q2016Slide4
Installation Instructions for Release 3For new users (no prior CPT edition installed)
Please follow
the
CPT Installation
Instructions
document. http://www.transceleratebiopharmainc.com/assets/common-protocol-template/For users updating to Release 3 (prior CPT edition already installed)Please uninstall the previous version and then follow the CPT Installation Instructions document. http://www.transceleratebiopharmainc.com/assets/common-protocol-template/Go to Control Panel>Programs and Features> and select the below 2 files to uninstall: CPT Intelligent Content ManagementCPT Library Management Add-InSlide5
Basic Features of the Tech-Enabled Edition
Architectural Approach
To provide
a single template applicable to all study phases and types, the CPT has been created using a modular approach to manage information. The Core Backbone establishes a common heading structure and recommended content applicable to all protocols, while content specific to participant type or disease area are separated into libraries.
To facilitate the user experience, manage the diverse information components, and enable reuse of content, the automated CPT was created within the MSWord
environment via customized Add-ins. Utilization of a metadata driven XML framework further facilitates content reuse and establishes the foundation for traceability and automationSlide6
Basic Features of the Tech-Enabled Edition
Navigation Pane
By enabling the navigation pane in the “View” tab of Word, the user will be able to see an interactive TOC within the CPT that will allow easy navigation throughout the sections of the template.
Data
Sources
PaneThe Data Sources Pane aids the user in managing the various library content and related instructional information supporting the template:a. Filter Library List Box Panelb. Instructional Text Box Panelc. Library Content Tree View Paneld. Preview Text Box PanelSlide7
Basic Features of the Tech-Enabled EditionLibraries
These Libraries are currently available in CPT:
Asthma
Diabetes
Healthy Volunteer
PatientConfiguring the libraries is done through the Data Sources Pane:Slide8
Basic Features of the Tech-Enabled Edition
CPT Tab
The CPT Tab within Word appears upon installations of the customized CPT add-ins. Users should navigate to this tab in order to utilize the
customized features created to manage CPT content. Examples include a variables list of content controls for common protocol elements, utilities to facilitate removal of example text, access to useful links, and a button for activating/deactivating the instructional text display. Detailed description of all the Technology-enable CPT functionality is found in the
CPT Guidance
for Use V2.Slide9
Basic Features of the Tech-Enabled EditionContent Controls
The use of content controls imbedded within the CPT and associated libraries enables the building of the XML backbone when drafting a protocol and facilitates content reuse in other parts of the document or potentially in other documents.
Users can enter their own data into a content control or insert from a Library.
Content Controls were also used to create a common variables list that allows the author to insert a control in multiple locations (for example – “Protocol Number”) and if an edit is made to one instance, it will be reflected in all other locations of the variable.
Below, the protocol number was established on the title page and updated as well in the document header which also contains the content control for that variable.Slide10
Basic Features of the Tech-Enabled EditionXML Extracts
Users are able to extract the data that’s entered in the protocol through the export functionality built into the template. A user would export the protocol and view data as illustrated below: Slide11
Release 3 - Functionality Updates to the Tech-Enabled Edition
The Following features are new or enhancements to the CPT for Release 3:
Prerequisite Analyzer
CPT Tab
Example Text Tools
Useful Links ButtonAbout ButtonCPT Admin TabManaged Variables Button Import/Export ButtonsObjectives and Endpoints TableSection 1 - Synopsis TableSection 4 – Objectives and Endpoints TableSlide12
Prerequisite AnalyzerPrerequisite Analyzer
The prerequisite analyzer will scan a user’s PC and confirm the appropriate versions of required programs have been installed. Slide13
CPT Tab – “Example Text Tools”Example Text Tools
In the Example Text Tools subsection of the CPT menu, we have 3 buttons, Convert, Remove and Next.
(1) Convert
– Converts example text to regular text. Contains a drop down menu that allows users to covert 1 instance of example text and move to the next or to convert
ALL
example text in the documentSlide14
CPT Tab – “Example Text Tools” cont.Example Text Tools (cont.)
(2) Remove
– Removes example
text
from document.
Contains a drop down menu that allows users to remove1 instance of example text and move to the next or to remove ALL example text in the document(3) Next - Searches for the next instance of example text in the documentSlide15
CPT Tab – “Useful Links”Useful Links Button
The “Useful Links” button will contain links to the TransCelerate website that will contain helpful information to the users about the template
Currently we have two links set
CPT Feedback
– Links to the CPT Feedback form on the TransCelerate site
CPT User Resources – Links to the FAQs & other supporting documentation on the CPT on the TransCelerate site Slide16
CPT Tab – “About”The “About” button will show
Version information and a link to the log files for the CPT Add-Ins
A new section entitled “Manage Templates” to help facilitate installing and updating
A new section entitled “Advanced Settings” to control access to administrative features Slide17
CPT Admin TabThis
tab maintains functions specifically targeted for administrative/technical users.*
Manage Variables Button - will allow users to edit and manage variables in the template
Export/Import
Data
- will allow users to import and export the XML of the created variables in the template and have the ability to feed into another system* Administrative/technical users would be those familiar with content management functions within word, content re-use with downstream documents, etc.(e.g. template managers)Slide18
Objective and Endpoint Table UpdatesSection 1 - Synopsis Table
This section is “read only” and upon first opening the synopsis section, it will be unpopulated.
The objective/endpoints table will become populated after objectives and endpoints are entered first in Section 4 of the template. Slide19
Objective and Endpoint Table UpdatesSection 4 – Objectives and Endpoints Table
With this release, a new row is required for each new objective.
Multiple endpoints per objective can be added inside of a cell in the table and will be visually aligned. Slide20
Objective and Endpoint Table Updates
Updating Section 1 – Synopsis
The Synopsis table will be updated after the Objectives and Endpoints table in Section 4.0 is populated. The author exits the Section 4.0 table and selects the objectives/endpoints to include, then clicks the refresh button.
By default
all primary objectives
are selected and the user may select the key secondary objectives to include. Slide21
Release 3 - Amendment Process
Protocol amendments are created by saving the current protocol version as a new document, and making
the
amendment changes
directly within the
new document (amendment). The templated PROTOCOL AMENDMENTS SUMMARY OF CHANGES TABLE section and its instructions are copied from the Common Protocol Template and pasted into the amendment document directly before the Table of Contents.The section includes:A DOCUMENT HISTORY containing the Document Number and Date of Issue for each amendment.Overall Rationale for the AmendmentDescription of Changes/RationaleSlide22
Release 3 – Selected Content UpdatesCore Backbone
Healthy Volunteer Library
Patient Library
Asthma Library
Diabetes Library
Selected Content Updates are presented in the following tables. Users of the CPT should review the Release 3 templates and comparison documents carefully for awareness of detailed changes included.Slide23
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale Title Page“Short Title” addedTo provide a shorter version of the title (maximum 300 characters) that may be used for Registry databases. Protocol Amendment Summary of Changes TableNew Section added.To provide a summary of all changes included in the Protocol amendment as compared to the prior protocol/amendmentSlide24
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 5.3 Participant and Study CompletionChange in Section heading - changed from “ End of Study Definition”, Text added to clarify the meaning of study completion.To provide definitions for participant completion of study, as well as study completion aligned with Registry database definitions.5.5 Dose Justification Change in Section heading - changed from “Justification for Dose”To reflect input from template reviewers to provide alignment with “Dose Modification” heading.Slide25
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 6.1 Inclusion CriteriaNew criterion added for Age. Instructions added regarding criteria around rescreening and body weight.To provide additional detail regarding authoring of this criterion.7.2 Dose ModificationChange in Section location – previously was Section 7.4To reflect input from template reviewers to provide improved flow of information.7.3 Method of Treatment AssignmentChange in Section location – previously was Section 7.2To reflect input from template reviewers to provide improved flow of information.Slide26
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 7.4 BlindingChange in Section location – previously was Section 7.3To reflect input from template reviewers to provide improved flow of information.7.7.1 Rescue MedicationNew Section heading added.To facilitate easier location of information regarding rescue medication.8. Discontinuation/Withdrawal CriteriaChange in Section heading – changed from “Discontinuation Criteria”To better reflect the content of the section.Slide27
Release
3
Section # and Name
Description
of Change from Release 2
Brief Rationale 8.1.2 Re-challengeChange in Section heading – changed from “Rechallenge”To reflect input from template reviewers.8.2 Withdrawal from the StudyChange in Section heading – changed from “Discontinuation from the Study”To better differentiate between participant discontinuing the study treatment and withdrawing from the study. 9.2.1 Time Period and Frequency for Collecting AE and SAE Information Text revised.To allow for the possibility of different reporting time frames to be defined for AEs vs SAEs.Core Backbone – Selected Template Changes in Release 3Slide28
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 9.2.5 Cardiovascular and Death EventsNew Section added.To facilitate easier location of information regarding these event types.9.2.6 Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs or SAEsNew Section added.To provide a section to describe events that are typically associated with the disease under study and will not follow the standard reporting process for AE/SAEs.9.2.7 PregnancyChange in Section location – previously was Section 9.2.5To reflect input from template reviewers to provide improved flow of information.Slide29
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 9.2.8 Medical Device Incidents (Including Malfunctions)Change in Section location – previously was Section 9.2.6To reflect input from template reviewers to provide improved flow of information.9.4 Safety AssessmentsChange in Section heading – changed from “Safety”To reflect input from template reviewers to provide alignment with “Efficacy Assessments” heading.9.7 GeneticsChange in Section heading – changed from “[Pharmacogenomics] or [Genetics]”To reflect input from template reviewers.Slide30
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 9.8 Biomarkers [and Imaging]Change in Section heading – changed from “[Biomarkers]”To provide clarity that this section may also include information about Imaging procedures.9.8.1 Immunogenicity Assessments [If applicable]Suggested Text removed from template.To reflect input from template reviewers.9.8.2 RNA Transcriptome Research [If applicable]Suggested Text removed from template.To reflect input from template reviewers.Slide31
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 9.8.3 RNA Expression Research of a Subset of RNA Species [If applicable]Suggested Text removed from template.To reflect input from template reviewers.9.8.4 Proteome Research [If applicable]Suggested Text removed from template.To reflect input from template reviewers.9.8.5 Metabolome Research [If applicable]Change in Section heading – changed from “Metabolomic Research [If applicable].” Suggested Text removed from template.To reflect input from template reviewers.Slide32
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 9.9 [Health Economics] OR [Medical Research Utilization and Health Economics] Change in Section heading – changed from “Health Economics OR Medical Research Utilization and Health Economics”To reflect input from template reviewers to allow flexibility in the title of this section to align with the content included.AppendicesAppendices are no longer subsections of Section 12. Instruction added to confirm that appendices may be modified, deleted or added as neededTo reflect input for template reviewers to list appendices as separate from the body by removing section numbers, and to provide clarity in instructions for appendices.Slide33
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale Appendix 3: Study Governance ConsiderationsCommon Text added regarding “Study and Site Closure.”To provide additional detail regarding authoring of this content.Appendix 5: Contraceptive Guidance and Collection of Pregnancy InformationSubsection headings no longer appear in Table of Contents.Note: Appendix 5 content was previously updated to align with CTFG (Clinical Trials Facilitation Group) guidance as part of Release 2.To provide a consistent and streamlined approach to Table of Contents elements, limited only to Appendix titles.Slide34
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale Appendix 6: GeneticsChange in Appendix title – changed from “Pharmacogenomics”To align with update in related “Genetics” section heading.Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Treatment Rechallenge Guidelines]Change in Appendix title – changed from “Liver Safety: Suggested Actions and Follow-up Assessments AND Study Treatment Rechallenge Guidelines”To correct an inconsistency between the section heading and Table of Contents reference, and to allow for flexibility in the title of this section to align with content included.Slide35
Core Backbone – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale Appendix 10: Protocol Amendment History New Appendix added.To align with the Protocol Amendment Summary of Changes Table in the beginning of document and to provide location for information pertaining to previous amendments. Slide36
Healthy Volunteer Library – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 6.2 Exclusion CriteriaUpdates made to several criteria.To reflect input from template reviewers.Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Treatment Rechallenge Guidelines]Update made to Follow-Up AssessmentsTo reflect input from template reviewers.Slide37
Patient Library – Selected Template Changes in Release 3
Release
3
Section # and Name
Description
of Change from Release 2Brief Rationale 6.2 Exclusion CriteriaUpdates made to several criteria.To reflect input from template reviewers.Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments [and Study Treatment Rechallenge Guidelines]Update made to Follow-Up AssessmentsTo reflect input from template reviewers.Slide38
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