Module 5 Presentations

05/07/2024

Organization related

Master data sources (xEVMPD / SPOR) • Timely registration of active substances / products in Medicinal Product Dictionary • Registration of your organization(s) in OMS / nomination of Sponsor admin • CTIS will only take the information at the time of its creation in CTIS (no live update) • Adjustment of the governance and management of master data sources for more alignment with clinical operations related activities (entity name changes, etc.) may be required CTIS, User Management and associated support systems • Strategic decision around keeping those in house / partly / fully delegating them • Direct impact on the outsourcing strategy and third party vendors / CRO qualification • need to a account for operational impacts of vendor changes on those aspects

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

45

Operational related

• User management • New activity around delegation and management of users through your organization and vendors (depending on your decision to manage Portal). • User delegation will only be by user name and individual (no company wide delegation) => Factor in the user management as part of your insourcing / outsourcing strategy and consider volume and scalability of that oversight depending on size of your portfolio • Availability of your organization details to be applied for sponsorship to new trials « open to all » till a Sponsor admin is nominated (switch to Organization-centric mode) • Intrinsic limitations with user delegation i.e. no geographic assignment for Part II preparers, Q-IMPD • CTR impacts on clinical operations • No overlapping substantial modifications: need to minimize number of amendments and better plan for their submission and deployment • New dynamics of applications procedures: anticipate differences in site activation ramp-ups and possible reduction of time between first and last site activations (EU wide): demand in clinical resources for site initiations may require more attention • New EU-wide notifications requiring even more focus on clinical systems’ compliance => Do not under-estimate the impact of CTR on Clinical Operations (not only submission related)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

46