Study Startup Best Practices: Kickoff Meeting

The TMF is evaluated at inspection, but its success is determined at the kickoff meeting. This is where expectations are set, ownership is established, and the foundation is laid for a Trial Master File that must hold up from study start through final inspection.

In Part 1, Gill Gittens and Laurel-Ann Schrader break down what an effective kickoff meeting must include to support TMF readiness across the full study lifecycle. The discussion focuses on early stakeholder alignment, clear definition of roles and responsibilities, and the decisions that most often create downstream gaps. This session sets the stage for Part 2, where those decisions are carried forward into eTMF execution and system activation.