Your Staff is trained, but can you prove it?

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

Transcript

Darshan 0:00

So, how do I staff and train my team? So, sponsors expect your staff to be trained in good clinical practices, protocol adherence, safety reporting. If your staff training is not documented, inspections can and have gone very poorly, even if your team is competent. I help create training SOPs and templates for logs, so staff training is fully documented. I also review contracts with coordinators, sub-investigators, and other staff to clarify roles and liabilities. Additionally, I provide coaching for handling protocol deviations and escalation procedures. This way, when the FDA or sponsors review your records, your site demonstrates a culture of compliance and readiness.