Your Clinical Systems Are Connected - Your TMF Governance Isn't

About this session

Part of Session 5, Track E: TMF Interoperability (Chair: Karen Roy, CDISC).

Clinical platforms have evolved. The eTMF no longer operates in isolation; it now sits within an interconnected ecosystem that includes CTMS, EDC, ePRO, and other clinical systems generating data, milestones, and evidence directly tied to TMF expectations.
This convergence creates a governance challenge. These systems follow different workflows, data models, and ownership structures, while traditional TMF governance, focused on document filing and periodic review,was not designed to manage cross-system dependencies or upstream accountability.
This session examines how TMF governance must evolve in a connected clinical environment. We explore how the TMF Governance Committee's scope expands from document oversight to cross-application data flows, process alignment, and system interactions. We discuss shifting roles and accountability when upstream system activity drives TMF expectations. Finally, we redefine TMF completeness, moving beyond document counts to confirming that expected evidence exists, is progressing, or is justified using metrics, metadata, and system signals,enabling continuous oversight across an ecosystem.

Speakers

• OR

  Olga Radyushkina

  Epista

  Speaker

• TN

  Tiffani Nelson

  Gilead

  Speaker

• KR

  Karen Roy

  CDISC

  Chair