Approaches to Implementing in Your Organization November 2018

Options for Adoption of the Common Protocol Template (CPT) CPT Components Companies and Sponsors select which to use TOC/Heading structure Common language (core/appendices) Participant Libraries (Healthy, Patient, Pediatric) Therapeutic Area Libraries (various) Word (BWE) or Tech-Enabled (TEE) template (“off the shelf”) Word (BWE) or Tech-Enabled (TEE) template (integrated into existing sponsor technology) Companies and Sponsors choose their own path to adoption By phases By use of libraries By use of Word or technology-enabled template 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 Legally approved Oct-2018 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. Sponsors may also choose to adopt the Word or Tech-Enabled template versions, and to use the template “off the shelf” or integrated into their existing technology. Harmonization Value

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/sponsor template. Consider: Impact to adding this content? Identify differences in wording of same topics in company/sponsor template vs CPT. Consider: Can company decide to accept CPT wording? Legally approved Oct-2018 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

Adoption of the Common Statistical Analysis Plan (SAP) and Mapping Table to Assess Impact Companies and Sponsors adopting the CPT may also choose whether to adopt the Common SAP. A Mapping Table Exercise will highlight the impacts and risks of adopting the Common SAP. 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 Common SAP. Consider: Is this information found elsewhere (e.g., Program SAP, Safety Analysis Plan, Issues Management Plan, Programming specifications, Standard Operating Procedures)? Identify content in the Common SAP that is not currently in a company/sponsor template. Consider: Impact to adding this content? Identify differences in wording of same topics in company/sponsor template vs Common SAP. Consider: Can company/sponsor decide to accept Common SAP 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

Adoption of the Common Clinical Study Report (CSR) Companies and Sponsors adopting the CPT may also choose whether to adopt the Common CSR. Mapping The Common CSR was built in adherence with ICH E3 and CORE guidance; as most companies/sponsors follow the same guidance, no mapping exercise has been created. The Common CSR vs. ICH E3 and CORE mapping document has been created for easy reference across sections. Identify content used in a company/sponsor template that is not included in the Common CSR. Consider: Is this information found/presented elsewhere (e.g., content to describe the Benefit/Risk profile of the intervention that would be better suited for a summary document and described across studies)? Identify content in the Common CSR that is not currently in a company/sponsor template. Consider: Impact to adding this content? Identify differences in wording or location of same topics in company/sponsor template vs Common CSR. Consider: Can company/sponsor decide to accept Common CSR wording? Legally approved Oct-2018 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).

Mapping Tools: Results of Initial Impact Assessment Each Company or Sponsor to tailor this slide. ! *Insert Company or Sponsor Specific Details* Share results of Mapping Tool Exercises 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 Technology Legally approved Oct-2018 Talking points depend on company or sponsor specific content on this slide.

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