Panel Discussion: The TMF Is the Trial - What eTMF Audits Actually Find

About this session

Inspectors don't open your protocol first — they open your file. And in audit after audit, the finding isn't that the work wasn't done; it's that the documentation can't prove it was. Missing delegation logs, training records signed months after the fact, notes to file written to explain gaps rather than prevent them, and version drift between site and sponsor copies turn sound trial conduct into citable findings.

In this panel, auditors who conduct eTMF reviews and mock inspections walk through the deficiencies they encounter most often — what produced them, what they cost, and what would have prevented them. Panelists discuss how documentation expectations have shifted under ICH E6(R3)'s risk-based approach, where site and sponsor filing responsibilities blur, and how to run a structured self-assessment before someone else runs one for you. The second half of the session is open to audience questions.

Speakers

• 

  Sandy Smith

  SVP, Clinical Solutions & Strategic Partnering · WCG Clinical

  Speaker

• MS

  Marilyn Stasinopoulos

  Sr. Manager, CTMS Services · WCG

  Speaker

• CF

  Carol Federline

  Senior Clinical Document Manager · Ocular Therapeutix, Inc.

  Speaker

• ST

  Suzanne Turner

  Owner & TMF Consultant · ICE Consulting

  Speaker