Your Staff is trained, but can you prove it?
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Your Staff is trained, but can you prove it?
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About this listen
Staffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff training. Competent staff is not enough if training is not documented. We walk through common failure points seen during FDA inspections, including missing GCP documentation, unclear staff roles, and poor escalation processes. We also discuss how structured SOPs, training logs, and clear contracts with coordinators and sub-investigators help demonstrate a real culture of compliance. The goal is simple. When sponsors or the FDA review your site, your records should tell a clear, defensible story.
Key Topics Covered
- GCP training and documentation expectations
- Why undocumented training creates inspection risk
- Common staffing failures seen during FDA inspections
- Training SOPs and staff training logs
- Defining roles and liability in staff contracts
- Managing protocol deviations and escalation paths
- Demonstrating a culture of compliance at the site level
Who This Is For
- Clinical trial sites
- Sponsors and CROs
- Principal Investigators
- Study coordinators
- Clinical operations leaders
Support the show
www.kulkarnilawfirm.com