Module 5 Presentations

05/07/2024

CTR impact considerations

While EU centric, CTR has a potential to affect global study operations around several areas: • Operational specificities affecting global core documents, processes and systems directly or indirectly connected with CTIS • Transparency requirements and their impact on document authoring and management of clinical trial applications / life cycle maintenance • Organizational considerations around scope and extent of activities retained in-house / outsourced A thorough impact assessment for your organization is therefore recommended to fully define company-specific impacts and drive the necessary adjustments

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

43

Readiness considerations

Readiness exercises standardly include: • Gap analysis of current state vs CTR requirements (impact assessment) • Identification of changes required , and their endorsement • Implementation of the changes (change management, resourcing, IT adjustments, trainings, communication) Now is the time to start your internal exercise if not already started Readiness exercises need to be adjusted to the: • Nature of your organization’s activities(Sponsor / CRO / specialized vendor) • Size, status and geography of your portfolio of studies (Transition) • Internal organization in relation to clinical trial systems and resources • Extent of outsourcing strategy

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

44