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Approaches to Implementing in Your Organization

This document outlines various options for adopting the Common Protocol Template (CPT) and provides guidance on the implementation process. It also includes a mapping table exercise to assess the impact of adopting the CPT. Companies and sponsors can choose their own path to adoption and set their roll-out timeline. The document also covers the adoption of other common templates such as Statistical Analysis Plan (SAP) and Clinical Study Report (CSR).

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Approaches to Implementing in Your Organization

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  1. Approaches to Implementing in Your Organization November 2018

  2. 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) • ParticipantLibraries (Healthy, Patient, Pediatric) • Therapeutic AreaLibraries (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 Harmonization Value

  3. 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/sponsortemplate. • Consider: Impact to adding this content? Identify differences in wording of same topics in company/sponsortemplate vs CPT. • Consider: Can company decide to accept CPT wording? EXAMPLE

  4. 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 SAPthat is not currently in a company/sponsortemplate. Consider: • Impact to adding this content? Identify differences in wording of same topics in company/sponsortemplate vs Common SAP. Consider: • Can company/sponsor decide to accept Common SAPwording? EXAMPLE

  5. 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/sponsortemplate. Consider: • Impact to adding this content? Identify differences in wording or location of same topics in company/sponsortemplate vs Common CSR. Consider: • Can company/sponsor decide to accept Common CSRwording?

  6. Mapping Tools:Results of Initial Impact Assessment • *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 • Each Company or Sponsor to tailor this slide. !

  7. Thank you

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