IT Considerations for CPT TEE Implementation

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.

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

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

5. Thank you