Common Protocol Template (CPT) Initiative - IT Considerations for CPT Implementation
- 1. December 2017 IT Considerations for CPT Implementation
- 2. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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. 2
- 3. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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 • 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 3
- 4. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * IT Subject Matter Expert Role – Key Responsibilities 4 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