Date: Friday, May 7 2021

Date Recorded: Tuesday, December 9, 2025

Course Type: Archived Event

Instructors: Ellen Vickery, MS

Learning Level: Fundamental

Primary Audience: All research team members

Prerequisite: None

Course Collection(s): Clinical Research Operations, Regulatory and Research Ethics

Audit readiness isn’t about surprise inspections — it’s about the everyday habits that make your studies compliant and stress-free.

Access the recording and materials from the December 9, 2025 Clinical Research Staff Quarterly Training: Everyday Audit Readiness: No Panic, Just Preparation. At this one-hour session, we unpacked what different types of audits look for, shared real-world tips to strengthen your documentation and processes, and showed how coordinators can turn routine work into proof of quality and participant safety every single day.

Learning Objectives

After completing this course, you will be able to:

• Describe the different types of audits and inspections (internal QA, sponsor, and regulatory) and what each aims to evaluate.
• Apply key documentation principles (ALCOA+) to ensure study records are accurate, complete, and traceable.
• Leave with at least one specific task to complete on your own study as a self-audit exercise or to enhance current processes.