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

2. How was the Common CSR Template Developed? Structure and Content
Adherence with ICH E3 & CORE guidance
Consistent with CPT headings
Template only contains CSR body; appendices and TFLs are left to company standards
Section Content
Streamlined structure to report data (no benefit/risk interpretation)
Streamlined common wording consistent with CPT
Adherence with ICH E3 and CORE guidance
Avoidance of redundancy by referring to appended documents
Legally approved October 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. Approach to the common Clinical Study Report
Collaboration
The expertise of sponsor companies has been tapped to develop the template
Stakeholders have the opportunity to suggest revisions; the template will be maintained and updated over time
Broad adoption will help drive greater efficiency for regulators and better feedback for sponsors
Based on well-known standards
The template was initiated in adherence with ICH E3 and CORE
Improved efficiency
The template is lean
Reduced redundancy due to reference to Protocol and SAP in the appendices
Less chance of error
Avoids duplication and possible contradiction with submission summaries
Legally approved October 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

4. How was the Common CSR Template Developed?
Participating Member Companies
Legally approved October 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
Guidance
E3: Structure and Content of Clinical Study Reports
Clarity and Openness in Reporting: E3-based

5. How was the Common CSR Template Developed?
Focus on a streamlined template to be used to report data, retaining any interpretation of benefit/risk profile of the product for clinical summary documents.
CSR Structure and Content will provide value to regulators
The same information is located in the same place and means the same thing across Sponsors
CSR Structure and Content are adherent with ICH E3 and CORE (Clarity and Openness in Reporting: E3-based)
Information requested in guidance is present in CSR content; order has been rearranged in some places
Refer to primary sources of information (e.g. Protocol, SAP) in appendices instead of duplicating information in the protocol
CSR content is significantly shorter and allows writer and reviewers to focus on the results of the study
Legally approved October 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. ​ 

6. What Does the Common CSR Template Look Like? The Model
Common CSR Backbone
Common Level 1 Headings
Common streamlined text
Used across all phases
Focus on reporting data
Appendices & TFLs
Guidance & Governance Model
E3: Structure and Content of Clinical Study Reports
Clarity and Openness in Reporting: E3-based
Legally approved October 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.
Apply Sponsor specific standards
TransCelerate
Implementation toolkit materials
Governance model in development at TransCelerate

7. What Does the Common CSR Template Look Like
What Does the Common CSR Template Look Like? Common CSR Template 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 Common CSR content
Initial Public Release: November 2018
Technology Enabled Edition
An MSWord-based template with add-ins
Automation to reuse content from the protocol
Anticipated Public Release: Fall 2019
For Microsoft Windows-based usage, not compatible with Apple iOS.
Legally approved October 2018

8. Common CSR Template is Intended to Prepare for the Future State
Foundation
Future
Human- Readable CSR
Machine- Readable Protocol
Content Reuse
Machine- Readable CSR
Regulators
Metadata driven processes
A common CSR template structure with harmonized language
Streamlined content and consistent structure enables identification of critical information for end users
Facilitate automated reuse of content from protocol to CSR to ensure consistency and improve efficiency
Reconnect processes (protocol to SAP and CSR)
Enable efficient content reuse downstream of the CSR (e.g. disclosures)
Legally approved October 2018
Progress to date includes the development 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, with common endpoint definitions based on the CDISC Therapeutic Area User Guide (TAUG).

9. Thank you