What is an audit trail in a research study system?

A record of who changed a participant record and when. It lets a lab answer questions about a record without relying on anyone’s memory.

How often should a lab review who has access to participant data?

On a schedule your institution agrees, and whenever someone joins, changes role or leaves. Many labs review at the start of each study period.

Does a spreadsheet have an audit trail?

Only if you set one up, and a shared file rarely records who changed what in a way you can rely on. This is one of the common reasons labs move to a system.

Research Study Data Access and Audit Trail Checklist: 10 Things to Check

A research lab can check its data access and audit trail by answering ten questions about who can see participant data, how changes are recorded and where the data lives. Use the checklist below on your current spreadsheets, on REDCap, or on any tool you are thinking of buying. Your institution and...