Before the visit

  • Confirm the date, the monitor's agenda and which subjects they plan to review
  • Book time with the PI and coordinator, and a workspace for the monitor
  • Arrange access to the records the monitor will need
  • Review open action items from the last visit and close what you can

What to check first

A short self-review catches a lot of what a monitor would otherwise find.

  • Consent: each subject signed the correct version, before any study procedures.
  • Source: visits are complete, corrections are explained, and data matches what's been entered in the EDC.
  • Visit windows: out-of-window visits are documented, along with any deviations.
  • Safety: adverse events are recorded and reviewed by the investigator.
  • Regulatory: approvals, delegation, licenses and training are current.
  • Product and samples: accountability, temperature logs and sample records are up to date.

During the visit

Keep someone available to answer questions, and check in at the end of each day so problems don't wait until the exit discussion. Record the visit in your site visit log. If you're giving monitors system access, make sure it's limited to what they need, and that blinded monitors can't see treatment information.

After the visit

  • Go through the follow-up letter when it arrives
  • Assign each action item an owner and a due date
  • Look for repeat findings, as they often point to a process problem
  • File the follow-up letter and your responses

Making review easier for everyone

Source data verification goes faster when monitors can find what they need without staff pulling it for them. Our clinical trial monitoring software gives monitors a read-only portal with an SDV trail, while your site keeps control of its records.

Want an easier next visit?

Tell us how monitoring visits run at your site today, and we'll show you what could change.

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