1. IT Considerations for CPT TEE Implementation
November 2018

2. IT Subject Matter Expert Role in CPT Implementation
When implementing the Common Protocol Template (CPT) Technology-Enabled Edition (TEE), a recommended best practice is to include a Business Systems Analyst role(s) on the core implementation team.
The primary focus of this role will be to gain knowledge of the CPT TEE and influence implementation.
Ideally, this role would sit in the IT organization.
While there may not be a heavy IT “lift” with implementing the CPT TEE, there does need to be a strong collaboration between the business and IT to ensure appropriate release management and support are in place.
Legally approved October 2018

3. IT Subject Matter Expert Role – Key Skillset
Knowledge of CPT Technology-Enabled Edition (TEE) capabilities
Knowledge of CPT TEE IT components and architecture to influence implementation
Proficient in the use of Microsoft Word
Understanding of technology platform and configuration for central storage of files
Familiarity with regulatory authoring, the use of templates, and knowledge of the inter- relationships of content between document types
Technical understanding of Extensible Markup Language (XML) and its role in digitizing content
Knowledge of authoring environments such as SharePoint, Documentum, Vault, etc.
Strong communication, interpersonal, teamwork, and self-management skills
Legally approved October 2018

4. IT Subject Matter Expert Role – Key Responsibilities
DURING IMPLEMENTATION
Engage CPT business Power Users to align on CPT tasks, processes, training, and support requirements
Ensure CPT implementation aligns with Sponsor architecture guidance
IT SME responsible for validating implementation
Partner with CPT business Power Users to develop guidance documents
Create/maintain custom libraries
RELEASE MANAGEMENT
Monitor TransCelerate CPT release roadmap
Plan and communicate upcoming CPT releases to business and IT partners
Perform impact assessment of TransCelerate CPT releases
Facilitate release testing and implementation as well as deployment communications
SUPPORT
Manage IT support in resolving CPT issues; work with CPT business Power Users to document issues, perform root cause analysis, and identify resolutions/workarounds
Submit, track, and report CPT metrics
Maintain CPT assets in a version controlled repository
MISCELLANEOUS
Gather and communicate feedback and future requests for TEE CPT enhancements to TransCelerate
Participate in Sponsor TEE CPT change control/governance body
Legally approved October 2018

5. Thank you