Learning Objectives for the session:

Operationalizing Compliance from Study Start-Up to Close-Out

• Identifying where regulatory risks in clinical research live and methods to help avoid last-minute scrambles

Training Staff for Ownership, Not Just Tasks

• Shifting from checklist compliance to real accountability using onboarding strategies, role-specific expectations, and clear task delineation

Internal QA on a Budget: How to Make Internal Audits Actually Happen

• Prioritizing high-risk areas, keeping audit tools simple and accessible, and creating a feedback loop that improves performance over time

Sustaining Readiness in High-Turnover, High-Volume Environments

• Preventing compliance drift by standardizing tasks, cross-training staff, and documenting institutional knowledge so it doesn’t become person-dependent