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Common Protocol Template (CPT) Initiative - Approaches to Implementing CPT in Your Organization
- 1. December 2017 Approaches to Implementing CPT in Your Organization
- 2. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Options for Adoption of the Common Protocol Template 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. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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? EXAMPLE
- 4. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Mapping Tool: Results of Initial Impact Assessment *Insert Company or Sponsor Specific Details* Share results of Mapping Tool Exercise 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. !
- 5. Thank you
Editor's Notes
- Legally approved 8-Apr-2017 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.
- Legally approved 8-Apr-2017 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).
- Legally approved 8-Apr-2017 Talking points depend on company or sponsor specific content on this slide.