TransCelerate is a nonprofit organization that aims to accelerate medical research by improving collaboration across the pharmaceutical industry. It has developed a Common Protocol Template (CPT) to standardize clinical trial protocols. The CPT provides a streamlined template for protocol content and format to make protocols easier to interpret, reduce complexity and costs, and enable automation. The CPT benefits various stakeholders by improving efficiency and quality. Its adoption by sponsors is valuable as it leverages industry expertise, supports compliance, and balances quality improvements with efficiency gains over time.

1. Executive Summary
Common Protocol Template
(CPT)

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What is TransCelerate?
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.
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 core values
 Quality
 Transparency &
Openness to new ideas
 Trust & Integrity
 Collaboration
 Courage

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Why a Common Protocol Template?
Heard at a June 2015 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!”
“If you have
standards without
traceability, then
you aren't really
CDISC
compliant.”
Investigator
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.”
Patient Advocate

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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 streamlined 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.
Background:
Why a Common Protocol 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.

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Near Term Benefits to Sites
• Protocols streamlined and
organized with an investigator
focus
• Reduced burden on sites
working on multiple studies
The Common Protocol Template Potentially
Benefits Many Stakeholders
Sponsor
Sites
IRB
Patient
Regulator
Near Term Benefits to Sponsors
• Reduction in redundant protocol content
• Enabling of therapeutic area
standards
• Improved conduct of the study
and quality of data collected
Potential Future Benefits to Sponsors
• Automation of downstream
processes and reuse of content
• Enabling of therapeutic area
standards in additional TAs
• Enabling collaborative clinical trials
Potential Future Benefits to Sites
• Opportunity to harmonize
additional documentation
• Enable consistency of some
case report forms
Near Term Benefits to IRBs
Increased consistency between
sponsor protocols: easier
review and faster approval
Potential Future Benefits to IRBs
Enabler for automation
of IRBs submissions
Near Term Benefits to Patients
Increased efficiency / quality in
clinical development for
participants & future patients
Potential Future Benefits to Patients
• Improved access to protocol
information
• Getting medicines faster, for
participants & future patients
Near Term Benefits to Regulators
• Protocols streamlined, increased
consistency between sponsor
protocols to ease review
Potential Future Benefits to Regulators
• Increased ease of data interpretation
and ability to compare protocols
(improves input on protocol design)
• Increased use of data standards
enabling end-to-end use of metadata
and traceability
Near
Term Potential
Future State

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• A common protocol template structure
with proposed model 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
o Analytics-driven trial design, modelling,
scenario planning
• Role-based access to protocol
information (Principal Investigator [PI],
Ethics, Participants)
• Connection to other systems
Common Protocol Template is Intended to
Prepare for the Future State
Human-
Readable
Protocol
IRB/IECs
Sites
Regulators
Foundation
Machine-
Readable
Protocol Metadata driven
processes
Content Reuse
Disclosure
SAP
CSR
eCRF
Statistical Output
Future

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Current State/Future State:
Establishing Our Direction
Where we started…
– Paper-based, manual processing
Where we are…
– Electronic,
document based
Where we should be…
– Digital, Cloud-based,
computable, re-usable
Today
• Manual processes and interventions
• Duplication of company efforts
• Disconnected interfaces
• Lot of customization
• Long cycle times
• Variable quality
• High costs
• Rework
• Patient-centric clinical
trial design
• Automated/seamless
interfaces / parallel
processing
• Quality by design
• Shorter cycle times
• Cost efficient
• “Integration of Data
Analytics”Incremental
Transformational

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Advisory Committee – Initial Development
eProtocol
Advisory
Committee
STAKEHOLDER FEEDBACK
“…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)”
“EMA has not agreed to take up a
position on the Advisory
Committee…..Happy to provide
comments on any draft templates…”
FDA 18-Mar-2016:
“Today we’re announcing a draft clinical trial
protocol template developed by the Food and
Drug Administration (FDA) and National Institutes
of Health (NIH) that should help with that. …..We
are aware of other efforts in this area, including
one undertaken by TransCelerate Biopharma Inc.
(TransCelerate), which has issued a common
protocol template intended to be the basis for a
forthcoming electronic protocol. Although our
initial target audiences differ, we plan to
collaborate with groups like TransCelerate to
help ensure consistency for the medical product
development community.”
Other Advisors or Influencers

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Further Development –
Alignment of CPT with NIH Template – May 2017
• Rationale/Goal
• Mutual desire to harmonize CPT and NIH templates
– Acknowledged different audiences: NIH template targeted at single-center and
investigator led studies; CPT targeted at multi-center studies.
– Harmonizing templates will drive harmonization in resulting protocols regardless of
template used
• Alignment on all Level 1 headings, and most Level 2 headings.
• Both CPT and NIH templates to be maintained, modifications made to
each to achieve greatest harmonization
• Updates Included
• Revised order/placement of several sections
– Where different Level 2 headings are required, they are placed after the common
Level 2 headings.
• Combined several sections
• Harmonized terminology where applicable

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Value Proposition – Why Should Sponsors Adopt?
Quality
• The expertise of 18+ member companies has been tapped to develop the template – the
work has been done for you.
• The template includes TA –specific libraries based on sponsor best practices.
• Sponsors will have the opportunity to suggest revisions, and the template will be maintained
and updated over time.
• Broad adoption will help drive greater efficiency for investigators, sites, sponsors, , and
regulators.
Efficiency
• Sponsors can spend less time on low-value customization, and reduce time managing
template maintenance.
• The template is easy for authors to use.
• Sponsors can adopt in a phased approach, and can choose to use either the Word version
or Tech-Enabled version. You don’t have to go “all in” at the outset.
Compliance
• The template is supported by FDA, and Health Authority feedback to date has been
unanimously positive.
Quality + Efficiency + Compliance = Value
Harmonization Value

11. THANK YOU