Clinical Research Documentation: How to Stay Audit-Ready at All Times

Are your trial documents audit-ready? If not, you’re playing with fire. Here’s how to keep your documentation flawless and compliant.

You can spot them from a mile away—the ones who panic when the email hits: “FDA Audit scheduled. Please prepare all essential documentation.” Their face goes pale. Their breathing shortens.

And suddenly, what once passed for a neatly labelled binder becomes a minefield of missing signatures, illegible notes, and outdated logs.

If this is you—or ever has …