1. Objectives and Guiding Principles for the Implementation Leader
The Implementation Toolkit is:
High level roadmap of activities recommended to support implementation of the Common Protocol Template (CPT) across project management, people, process & technology
Templates and materials to communicate the initiative to various audiences
Available to any Company or Sponsor who chooses to implement
.. but is not:
A detailed step-by-step workplan
Activities that must be followed exactly, including Company or Sponsor-specific documentation
The toolkit can be used in a highly flexible manner, as reflected in the guiding principles below. i
Guiding Principles
Each TransCelerate member company or non-member Sponsor is free to decide and must decide for itself whether and in what manner to adopt any or all of the CPT components.
This toolkit is intended to help those Companies or Sponsors who decide to adopt any CPT component to do so in the most efficient way possible.
Implementation components are generic and may need to be tailored to a sponsor prior to use
While TransCelerate member companies or non-member Sponsors have absolute discretion to implement TransCelerate solutions as they see fit, changing certain CPT tools will likely reduce some of the benefits associated with the tools.
It is up to each TransCelerate member company or non-member Sponsor to define further the detailed steps for each implementation component within their respective organization.

2. Common Protocol Template (CPT) Implementation Toolkit
<Audience and Date>
<Insert description of member company or sponsor audience for this presentation – e.g. senior leadership, group of stakeholders for doing impact assessment, participants authoring “pilot” trials, team members who will review and approve the protocol for “pilot” trials, broad audiences>

3. TABLE OF CONTENTS Introduction to TransCelerate
Common Protocol Template (CPT)
Background
Model for the CPT
CPT Implementation Plan: Stakeholders, Advisors, and Company Plans
CPT Tools and Training for implementation
Other Tools to Support Implementation

4. What is TransCelerate?
TransCelerate is a not-for-profit entity created to drive collaboration across the pharmaceutical industry as a means to developing solutions for overcoming inefficiencies
Our vision
To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
Our mission
To collaborate across the global research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.
Our core values
Quality
Transparency & Openness to new ideas
Trust & Integrity
Collaboration
Courage

5. Engagement With the Wider Clinical Ecosystem Globally
Strategically focusing engagement efforts with selected key stakeholder groups – the intent is not to recreate, but partner whenever feasible
Industry Initiatives
Investigative sites
TransCelerate is well aware that it is part of a very wide healthcare eco-system. It is one thing to develop and design solutions that will benefit the pharma companies, it is another thing to get them adopted more broadly by the industry as a whole. Therefore it is critical for TransCelerate to engage with, and secure feedback from a variety of partners in the industry and regulatory bodies.
Some examples:
TransCelerate has engaged with BIO - BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations to ensure they understand what TransCelerate is trying to accomplish and are aware of TransCelerate’s proposed solutions for the industry.
Secondly, as many of TransCelerate’s solutions are intended to improve efficiency at the study-level, ensuring that Investigator Sites and Clinical Research Organizations are aware of TransCelerate is important. To that end TransCelerate recently finalized an agreement with the Society for Clinical Research Sites (SCRS)  establish dedicated Site Advocacy Groups, specifically to participate on TransCelerate workstream.  SCRS is a fast growing global organization created by the investigator community to advocate for the investigator community. SCRS provides TransCelerate direct access to investigative sites in the US, Europe, Latin America and soon China.   Through this newly formalized partnership, TransCelerate's working teams will have direct access to these top sites and investigators to gather timely input/feedback on various workstreams outputs. TransCelerate also engages with CROs through their trade organizations, ACRO and JCROA in Japan.
Finally, TransCelerate recognizes the importance of open lines of communication & dialogue with regulatory bodies / health authorities around the world to ensure their input and guidance is obtained on proposed solutions and that their feedback is taken into account prior to any releases of deliverables. Efforts are ongoing to obtain this important input.
Regulatory Bodies
Research and CRO Community

6. How Does TransCelerate Work?
Support & Resources
(subject matter experts, time, overhead)
WORKSTREAM
Define problem scope
Share best practices
Discuss challenges
Co-create solutions
Member Companies
Industry Solutions

7. 14 TransCelerate Initiatives Chartered - All initiatives are voluntary8
Model Approach for High-Quality, Risk-Based Monitoring*
Pediatric Trial Efficiencies 2 9
Shared Site Qualification and Training*
Clinical Trial Diversification 3 10
Shared Investigator Platform*
Clinical Data Transparency 4 11
Clinical Data Standards* (as a collaborator in CFAST)
Quality Management System 5
TransCelerate currently has 14 projects which share the goals of increasing quality, patient safety & Accelerating development timelines 12
Comparator Drugs for Clinical Trials*
Placebo / Standard of Care 6 13
Common Protocol Template
e-Labels 7 14
Investigator Registry
e-Consent
*Original initiative which began in 2012

8. TransCelerate and CPT Workstream Membership
companies
participate in the Common Protocol Template workstream
20 member
companies in TransCelerate
In slide show mode, first all TransCelerate member companies will appear. With advance, those not on the WS will fade.
TransCelerate has 20 member companies with most member companies represented on the Common Protocol Template workstream.  This collective effort for the creation of the CPT has leveraged the talent and experience across the pharma industry.

9. Why a Common Protocol Template?
“If you have standards without traceability, then you aren't really CDISC compliant.”
Heard at a recent DIA meeting…
“Patient recruitment is challenged by the complexity of protocols. Sponsors do the same things too many different ways. Just make it the same!”
FDA
“Just because ‘subject’ is in the regs, doesn’t mean you have to use it. Patients think of ‘subject’ as a verb, and who wants to be subjected to something? Please use ‘trial participant’ instead.”
Investigator
Patient Advocate

10. Background: Why a Common Protocol Template?
Problem Statement
Format and core content of study protocols vary from sponsor to sponsor making interpretation difficult for study sites, IRBs, and regulators.
Study protocols have become increasingly complex and lengthy driving up cost and time.
Manual set-up of clinical systems based on non-standard “manual” protocols is time consuming, costly, and prone to error.
Solutions
Develop a model clinical trial protocol, including format and core content, to ease interpretation and enable down- stream automation of many clinical processes.
Develop model protocol endpoint definitions, incorporate into piloting of the template.
Guiding Principles
“Common” in a CPT: information always in the same place, means the same thing.
Is it better? Move beyond incremental improvements and current limitations.
It has to be better for everyone, but Investigators/Sites are the first priority.
A human readable template that paves the way for an automated solution and facilitates the use of data standards.

11. End-User Stakeholders and Key “Must Haves” Define Scope and Solutions
Investigators / Sites IRBs
Physicians
Clinical Scientists
Operations
Regulators
Data Scientists
Stats & Programming
Metadata
Traceability
Reuse
Automation
The CPT workstream is representative of end users, such as Clinical Development Scientists, Medical Writers, Data Scientists, and other professionals who develop protocols and implement clinical trials. The Team aims to evolve both a document-based protocol template as well as an early machine-readable protocol with the end users in mind.
The blue arrow on the left side of the slide depicts the focus and makeup of people who typically comprise a sponsor’s study team while the red arrow on the right side of the slide reflects the focus of end users who are downstream of protocol development. The CPT endeavors to create connectivity from end to end. However, both document-based and digital solutions need to fit relatively seamlessly into the workflow of the Teams reflected on the left in order to drive uptake and minimize disruption.
Metadata, Traceability, and automation of reuse have become the fulcrum upon which the CPT Team balances trade-offs in an effort to establish some level of harmonization in the way protocols are presented. Those elements which potentially limit the ability to create end-to-end traceability and automate reuse typically get more focus.
Objectives
Endpoints
Methods
Time & Events
Supplies
Protocol Representation Models (CDISC)
Data Flows
Data Standards
Protocol Elements
Concepts

12. The Common Protocol Template Potentially Benefits Many Stakeholders
Operational efficiencies in creation of protocols
Reduction in redundancy in protocol content
Enabling of therapeutic area standards
Improved conduct of the study and quality of data collected
Automation of downstream processes and reuse of content
Enabling of therapeutic area standards in additional TAs
Enabling collaborative clinical trials
Near Term and Potential Future State
Improved access to information with protocols streamlined and organized with an investigator focus
Increased consistency between sponsor protocols makes it easier when conducting multiple studies
Reduced need for additional documentation (e.g., study manuals)
Sponsor
Reduction in complexity of regulatory reviews – easier reviews due to common structure and content
Increased ease of data interpretation
Improved ability to compare protocols, which improves quality of regulatory input on protocol design
Regulator
Sites
Increased use of data standards, enabling end-to-end use of metadata and traceability
The benefit of the Common Protocol Template (CPT) will be felt by the separate and inter-related groups, as illustrated here.  The first step is the CPT will be used to create protocols supplied by the sponsor to the Investigators.  The Investigator and the site staff will see the common protocol structure in use, ideally by multiple sponsors, with same information in the same section across multiple sponsors.  The use of the CPT is expected to enable the site staff to more quickly develop their required study documents and tools by saving time looking for specific sections in a protocol document. 
Protocols written using the CPT will be sent to the IRBs and Regulators.  The same effect is expected; the IRBs and Regulators will find the same information in the same location in protocols written using the CPT across multiple sponsors.  Use of this CPT, is expected to ease and facilitate the IRB review of protocols.
The use of the CPT is projected to potentially shorten the start-up at the sites and the review by the IRBs and Regulators who will be reviewing information in the same structure across multiple sponsors.
This may result in the study starting sooner, with a benefit to the patient who may be waiting to enter a clinical study.
Opportunity for harmonization of additional documentation (e.g., study manuals)
Enabling increased consistency of some case report forms
Improved communication from sites due to Increased consistency between protocols
Improved access to protocol information
Increased efficiency in clinical development, for participants & future patients
Patient
IRB
Improved access to information with protocols streamlined
Increased consistency between sponsor protocols - easier review and faster approval
Getting medicines faster, for participants & future patients
Enabler for automation of IRBs submissions

13. Common Protocol Template is Intended to Prepare for the Future State
Foundation
Future
Human- Readable Protocol
Disclosure
SAP
CSR
IRB/IECs
Sites
Regulators
Machine- Readable Protocol
Content Reuse
eCRF
Statistical Output
Metadata driven processes
A single, common protocol template structure with harmonized language
Streamlined content enables identification of critical information for end users
Begin working towards common endpoint definitions to align with Clinical Data Interchange Standards Consortium (CDISC) Therapeutic Area (TA) data standards. Asthma and Diabetes available in the first release.
Reconnect processes (protocol, eCRF, development)
Transformation of the design process
Analytics-driven trial design, modelling, scenario planning
Role-based access to protocol information (Principal Investigator [PI], Ethics, Participants)
Connection to other systems
Progress to date includes the development of Version 1.0 of a human-readable template document. This will enable sites, reviewers, ethics committees and regulators to find the same information in the same place and have it mean the same thing. The template consists of a core of common content supported by a series of libraries appropriate for a given study type or disease area. Critical protocol level content has been aligned to the data standards project which is a collaboration between TransCelerate and Coalition for Accelerating Standards and Therapies (CFAST). The alignment of objectives, endpoints and procedures is a critical element of the document-based solution.
This template paves the way to evolving to a machine-readable protocol - introducing the possibility of establishing the protocol as a digital platform with analytic trial design, role-based access to protocol information, etc.
In both the document based environment as well as the digital environment it will be critical to reconnect certain processes and develop critical study components in parallel rather than serially (e.g. eCRF, Statistical Analysis Plan –SAP)
At this time, the template core will support trials in any Therapeutic Area. As a first step toward enabling data standards, disease specific libraries have been created for Asthma and Diabetes, with common endpoint definitions based on the CDISC Therapeutic Area User Guide (TAUG).

14. The Model for the Common Protocol Template
Core Protocol Backbone
Common Level 1 & 2 Headings
Common text
Used across all phases
Focus on investigators
Libraries
Libraries group and store content which is used to populate the template
Healthy Volunteer
Core is streamlined and focused on site needs
Patient
Asthma
Endpoint Definitions developed for asthma and diabetes
Diabetes
Backbone contains the protocol information common to all phases, populations, and therapeutic areas. The core is streamlined and focused on the sites’ needs.
Libraries group and store content to be inserted into the core backbone and contain specific information related to therapy, country, study population (e.g., patient, healthy volunteer) needs.
Appendices provide additional information that can be accessed when needed (e.g., abbreviations, company specific content). Appendices are omitted if not applicable.
Highlight that the template is for all TAs. For Asthma & diabetes have some additional content
Proposed Appendices to apply as applicable
Appendices
Non-study specific info, items triggered by event
Common Protocol Template and Guidance
Governance Model
A sustainable Governance Model is currently in development
Implementation materials in Toolkit

15. Template Development: Structure and Content
Structure – Level 1 and 2 Headings
Main focus - Streamlined structure for logical flow
Review of structure (Table of Contents) of member company templates
Input from SCRS (Society for Clinical Research Sites) Site Advocacy Group
Final CPT Structure and Content
Focus on sites (investigators and study staff) to have access to protocol information
CPT Structure and Content will provide value to Investigators, site staff, IRBs, regulators
The same information is located in the same place and means the same thing across Sponsors
Locked text (Level 1 and 2 Headings) is not to be modified or removed. “Not Applicable” is inserted if a section is not applicable.
Specific information to evaluate the ability to conduct a protocol, e.g. does the site have the patient population.
Refer to primary sources of information (e.g. Investigator Brochure) instead of duplicating information in the protocol
Model sections and text located in Appendices to be accessible, but will not impact the flow of the core protocol-specific information
Content development was a logical, thoughtful approach, acknowledging that not one member company protocol was preferred over another, as all meet the GCP and ICH requirements.  The main focus was to streamline the content to allow for consistency across the pharma industry.
The structure of the Level 1 and 2 headers are intended to be used/adopted for use without changes.  If a section does not apply, retaining the heading and inserting “NA” or “Not applicable” will allow a consistent protocol structure for multiple sponsors across industry.  The impact will be that the Investigators, study staff and IRBs will be able to locate the same information in the same place and meaning the same thing across multiple protocols.
The Level 3 headers and lower level headers can be adjusted as needed .
GCP and ICH guidance was reviewed as the initial step for creating common core content.  A comparison of the content in the member companies protocols was completed as part of the development of the common core content. With intended focus on sites (investigators/coordinators), the core includes content to (1) evaluate whether a site has the patients/facilities/time to conduct a protocol, and (2) the specific information needed to conduct the protocol. Other items have been placed in appendices (including governance-related text) where they are accessible but do not impact the flow of the core information. The core content guidance provided with the template also suggests that the reader refer to the primary sources of information (e.g. IB), where possible, rather than bulk repetition in the protocol. This organization in the document has the added advantage of streamlining the protocol overall. This streamlining is expected to allow more efficient use of the protocol. ​ 
Section Content
Identification of common wording in Core Backbone
Review of GCP, ICH, and EU requirements
Review of content from member company templates

16. eProtocol Advisory Committee
“…to inform the development of a common human readable and electronic protocol template and provide a forum for key stakeholders to inform future direction and provide know-how (Committee Charter)”
eProtocol Advisory Committee
TransCelerate sponsored formation of the Electronic Protocol Advisory Committee to inform the development of a common human readable and electronic protocol template and provide a forum for key stakeholders to inform future direction and provide know-how. This Advisory Committee was designed to be similar to, but lighter version of, the Coalition for Accelerating Standards and Therapies (CFAST) structure. Input has been received from some eProtocol Advisory Committee members, and additional input is being requested. The intent is to promote “energy” around the idea of an eProtocol platform, and to drive alignment around end to end traceability, automation, and reuse. Through this Advisory Committee, TransCelerate workstreams will continue to get advice, and access to external “know-how.” The groups across the bottom of this slide are not directly involved in this Advisory Committee, but their outputs have been considered in developing the CPT, and their influence is considered via the other Advisory Committee channels. Tufts was consulted specifically regarding CPT project scope, priorities, and deliverables. The SPIRIT checklist was a key reference and influenced the creation of the text-based structure and content. A consultative meeting was held with the Budapest Working Group, with additional input pending. It is envisioned that additional advisors, such as HL7 and IHE, will be pursued as we move toward development of the machine-readable template
“EMA has not agreed to take up a position on the Advisory Committee…..Happy to provide comments on any draft templates…”
Other Advisors or Influencers
Budapest Working Group (E3 & E6)
Stakeholder Feedback

17. Case Study: Member Company Pilot of TOC
The DRAFT CPT TOC (Level 1 and 2 headers) was used by a member company to author 3 protocols. There were no comments on the protocol TOC from the IRBs or the FDA or other Health Authorities for Trial 1 or 2 or 3. Several ex-US HA approvals are pending.
Trial
Type of Study
Phase
Indication
# of IRBs/EC Approved
FDA Review Approval
Ex-US Health Authority Review Submitted
Prot
Approved to date by Ex-US HA 1
Oncology II
Gastric
 38
yes
UK, Belgium, Canada, Czech Republic, Germany, Greece, Italy, Spain, Sweden, Turkey, Ukraine
All approved except Ukraine pending 2
 43
Argentina, Australia France, Hungry, Poland, Romania, Russia, Slovakia, UK
All approved expect Argentina pending 3
Auto-immune
III
Psoriasis
 124
Argentina, Australia, Brazil, Canada, Czech Republic, Germany, Hungry, Japan, Mexico, Poland, Romania
All approved except Brazil pending
A member company  piloted the CPT TOC structure (Level 1 and Level 2) headings in 3 protocols.  The current status of these protocols is included in the table.  There were no comments received from the Health Authorities or IRBs reviewing and approving the protocol. One additional protocol using the CPT structure is on hold with no information to report -

18. Ongoing CPT Maintenance/Governance: Business Continuity Plans
Governance Model being refined
Posted Template & Implementation Toolkit
Member companies
Public
Ongoing Maintenance & Governance of Template*
Collect and report metrics and feedback
Updates to the templates and libraries
Update of the template and libraries as needed based on stakeholder feedback, regulatory guidance etc.
Additional TA libraries
Metrics to monitor extent of adoption, regulator feedback
Metrics to assess efficiencies gained
Feedback collected via the TransCelerate website

19. How will we go about adopting the CPT?
Each Sponsor to tailor this slide. !
Options for Adoption of Common Protocol Template
TransCelerate  Sponsor
Mapping Table Exercise for assessing the impact of CPT
Plan for Implementation at _Sponsor_

20. Options for Adoption of the Common Protocol Template
CPT Components
Companies select which to use
TOC/Heading structure
Common language (core/appendices)
Healthy Volunteer Library
Patient Library
Asthma Library
Diabetes Library
Companies and Sponsors choose their own path to adoption
By phases
By use of libraries
By use of organization/structure and content only (i.e., existing sponsor technology used, but headings/content adapted to mirror CPT)
Companies and Sponsors set their roll- out timeline
Slowly introduce through pilots
Hard cut over date
Somewhere in between
Each individual company or sponsor chooses whether and how to implement.  The intent is for a detailed discussion to occur with the stakeholders at each sponsor company who are involved in clinical development.  It is recommended that CPT components be incorporated as outlined.  For example, adoption of the CPT heading structure without modifying the heading titles or order will enable the harmonization and benefit the Investigators, IRBs, Regulators, etc, who will see the same information in the same location

21. Mapping Table Exercise to Assess Impact of CPT
Completing the Mapping Table Exercise will highlight the impacts and risks of adopting the CPT. Consider:
Impact to sites/regulators
Sponsor responsibility for regulatory compliance
Impact to internal sponsor processes and documents downstream from protocol
Identify content used in a company sponsor template that is not included in the CPT
Consider: Is this information found elsewhere (e.g., CTA, Monitoring Guidelines, Standard Operating Procedures, policy documents)?
Identify content in the CPT that is not currently in a company or sponsor template.
Consider: Impact to adding this content?
Identify differences in wording of same topics in company or sponsor template vs CPT.
Consider: Can company decide to accept CPT wording?
An optional Mapping Table Exercise may be performed. The purpose is to ensure alignment of your company’s/sponsor’s protocol template to the CPT. This will allow you to map the location of content in the CPT as compared with your company or sponsor template, ultimately facilitating populating the CPT. It will provide transparency across content by identifying gaps and trigger the need to identify where (other than the protocol) within your organization this information is found (e.g. CTA, Monitoring Guidelines, Standard Operating Procedures, policy documents).
EXAMPLE

22. Mapping Tool: Results of Initial Impact Assessment
Each Company or Sponsor to tailor this slide. !
*Insert Company or Sponsor Specific Details*
Share results of Mapping Tool Exercise
Propose mitigation for content removed from template
Downstream impacts of content changes – distinguish between what needs to be mitigated for initial implementation vs longer term updates to SOPs
Documents (SOPs, monitoring plans, agreements, etc.)
Processes
Talking points depend on company or sponsor specific content on this slide.

23. Proposed Implementation at ____Sponsor ___
Each Company or Sponsor to tailor this slide. !
*Insert Company or Sponsor Specific Details*
Pilot with X trials
Trials X, Y, Z
Use template on desktop, not installed in authoring tool for initial implementation
Training/Orientation to template details
Timing
Assessment of results
Talking points depend on company or sponsor specific content on this slide.

24. How to Use the Common Protocol Template
CPT Version 1.0 – Basic Word
CPT Core Backbone and Libraries in MSWord (.docx)
Instructional text provided as red hidden text available by toggling paragraph marks
Word doc, no installation needed (Open file and “Save As”)
Open on a workstation to author a protocol or
Use for mapping exercise to compare sponsor template to CPT

25. What will be provided to support Implementation?
Tools
What is it?
Introductory Video
Short video providing an introduction to the template and the CPT Project
CPT Implementation Toolkit – Slide deck
This deck. Used for communication to various company or sponsor audiences – e.g. senior leadership, group of stakeholders for doing impact assessment, participants authoring “pilot” trials, team members who will review and approve the protocol for “pilot” trials, broad audiences for awareness.
Frequently Asked Questions (FAQs)
A summary of questions, and responses from the team, that various stakeholders may have about how the CPT was developed, how it will be implemented, and how it will be maintained.
Mapping Table Exercise; Mapping Table Instructions
A tool to compare the CPT to a company or sponsor protocol template. Allows identification, section by section, of differences in headings and content, and prompts team members to assess impact of implementation and possible mitigations needed.
Stakeholder Map
A tool to assess the impact that implementing the CPT will have on each stakeholder group. Allows the Implementation Lead to plan for appropriate training and mitigation of concerns.
Text Color Guide
Color coding used within the Common Protocol Template to distinguish common, suggested, example and instructional text. Paragraph marks must be visible in order for the instructional text to be displayed.
CPT Feedback
Feedback can be submitted via the TransCelerate website

26. THANK YOU