1. Status of Adoption and Maintenance/Governance
November 2018

2. Status of Adoption
Almost 6,000 Downloads of the CPT from TransCelerate website through September 2018!
Member companies, other sponsors, academic institutions, major cancer centers health authorities. Across all major global regions.
15 Member Companies (MC) are adopting CPT. 2 MCs evaluating.
Adoption Status Reported via voluntary Public Survey (2017):
Study Phases using CPT
I, II, III, IV
Geographies where CPT is used
N America, S America, UK, Europe, Japan, China, Asia Pacific, Africa/Middle East
Therapeutic Areas where CPT is used
Cardiovascular, Dermatology, Gastroenterology, Immunology, Infectious Diseases, Metabolic Disorders, Neuroscience, Oncology, Ophthalmology, Respiratory, Urology, Vaccines, Women’s Health, Devices
Health Authority comments on CPT text/format
95% no comment; 5% comment(n=1);
0% rejected/mandatory revisions due to CPT text/format
IRB/ERC comments on CPT text/format
100% no comment; 0% comment;
Legally approved October 2018

3. CPT Maintenance/Governance
Governance Model implemented
Posted Templates & Implementation Toolkit
Ongoing Maintenance & Governance of Templates
Collect and report metrics and feedback
Updates to the templates and libraries
Update of the templates and libraries as needed based on stakeholder feedback, regulatory guidance etc.
Additional libraries
Metrics to monitor extent of adoption, regulator feedback
Metrics to assess efficiencies gained
Feedback collected via the TransCelerate website
Legally approved October 2018

4. Testimonials and Value Stories
See the additional Toolkit Resource “CPT Testimonials and Value Stories” for recent feedback from the User Community, including:
Benefits realized by companies who have already adopted templates
Reactions to the templates from internal teams (Sponsor) and external users
Tips for organizations considering adopting templates
An example of a Sponsor journey
Legally approved October 2018

5. Thank you