/
Release 3 Highlights Release 3 Highlights

Release 3 Highlights - PowerPoint Presentation

cheryl-pisano
cheryl-pisano . @cheryl-pisano
Follow
386 views
Uploaded On 2017-08-28

Release 3 Highlights - PPT Presentation

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

release section cpt template section release template cpt change text content reflect reviewers input table selected protocol rationale heading information study core

Share:

Link:

Embed:

Download Presentation from below link

Download Presentation The PPT/PDF document "Release 3 Highlights" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.


Presentation Transcript

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-20152.0Dec-20153.0June-20164.0Planned 4Q2016Slide4

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

THANK YOU