1. How was the Common Protocol Template Developed and What Does it Look Like?
November 2018

2. How was the Common Protocol Template (CPT) First Developed
How was the Common Protocol Template (CPT) First Developed? Structure and Content
Structure – Level 1 and 2 Headings
Main focus - Streamlined structure for logical flow
Review of structure (Table of Contents) of anonymized member company templates
Input from SCRS (Society for Clinical Research Sites) Site Advocacy Group
Section Content
Identification of common wording in Core Backbone
Review of GCP, ICH, and EU requirements
Review of content from member company templates
Legally approved Oct-2018
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. ​ 

3. How was the CPT Developed? Initial Advisory Committee Engagement
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.”
“…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
Legally approved Oct-2018
TransCelerate sponsored formation of the Electronic Protocol Advisory Committee to inform the initial 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

4. How was the CPT Developed? Final Template
Focus on sites (investigators/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
Legally approved Oct-2018
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. ​ 

5. What Does the CPT Look Like?
Libraries group and store point and click content used to populate the template
Core streamlined, focused on site needs
Participant Libraries
Core Protocol Backbone
Common Level 1 & 2 Headings Common text
Used across all phases
Focus on sites (investigators/study staff)
Healthy Volunteer
Patient
Common Text can be used “as is”- relevant across study types
Pediatric
Therapeutic Area Libraries (various)
Endpoint Definitions modeled for TAs/indications
Legally approved Oct-2018
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. Additional content available for some specific therapeutic areas.
Appendices to apply as applicable
Appendices
Non-study specific info, items triggered by event
A sustainable Governance Model is in development
Common Protocol Template and Guidance
Governance Model
Implementation Toolkit Materials

6. What Does the CPT Look Like? CPT Editions
Basic Word Edition
A document based template for use across phases and study types
Use as-is or modify current format template to reflect CPT content
Initial Public Release: December 2015
Technology Enabled Edition
An MSWord-based template with add-ins
Automation to leverage “point and click” protocol text
Capture of protocol-level metadata to facilitate content reuse and extraction
Initial Public Release: June 2016
For Microsoft Windows-based usage, not compatible with Apple iOS.
Legally approved Oct-2018

7. What does the CPT Look Like? Basic Word Edition
Word documents; No installation needed.
Locate the Basic Word Edition files on the TransCelerate CPT Website
Under” Common Protocol Template Tools and Resources,” click on the blue bar “Basic Word Edition Template and Guidelines” to reveal all of the available resources. To download the CPT BWE, click on “Basic Word Edition Core Template.”
Participant and Therapeutic Area Libraries are also available. To download any of the files, click on the file and “Save As” to add the files to your desktop or local drive.
Start authoring your protocol.
Legally approved Oct-2018

8. What does the CPT Look Like? Basic Word Edition
Instructional text provided as red hidden text available by toggling paragraph marks
“Start” and “stop” of common text is indicated in green font
Legally approved Oct-2018
“Start” and “stop” of common text is indicated in green font

9. What Does the CPT Look Like
What Does the CPT Look Like? Tech-Enabled Edition It still looks like paper….but its not!
The Technology Enabled Edition of the Common Protocol Template (CPT) avoids media breaks by capturing structured and unstructured information in variables available for export and reuse downstream.
Libraries make model content available
Common layout of content
Export variables to XML or Excel for reuse in other processes
Legally approved Oct-2018
Information is captured in variables

10. Thank you