Monitoring plan compliance

The monitoring plan, executed — not filed.

A monitoring plan states cadence, tolerance windows, and report deadlines — then usually sits in a folder while visits get scheduled from memory and email threads. Nuqleus turns those written obligations into the visits a monitor actually works, on the schedule the plan specifies.

How it works

From a written plan to visits inside their window.

01

Every rule carries the sentence it came from.

Nuqleus reads the approved plan into structured visit rules — type, anchor event, cadence, tolerance window either side, and report deadline. Each rule arrives with the plan section behind it, the verbatim sentence it was drawn from, and a confidence rating, so a reviewer checks it against the source rather than taking it on trust.

02

Where the plan contradicts itself, nobody guesses.

Competing cadences are surfaced as conflicts, with each candidate value and the quote behind it, instead of being quietly resolved. Approve & Lock stays disabled until a reviewer has settled every one — and only then does the plan become visit templates and reach the study's monitored sites.

03

One chain per rule, generated from first enrolment.

At the first patient enrolled, routine visits generate across a twelve-month horizon — and a plan carrying both an on-site and a remote routine produces two independent chains on their own cadences. A site's risk tier sets the on-site interval for visits still to come, never for those already scheduled.

04

The window is a limit, not a suggestion.

Rescheduling a visit outside its tolerance window is refused outright rather than warned about, and the originally planned date stays on the record either way. Report deadlines are counted in business days in the site's own timezone, with a reminder before one falls due and escalation to the monitor and the sponsor once it passes.

Scheduled directly

The visits no cadence can predict.

A generated chain needs an anchor and an interval. Three kinds of visit have neither, so a monitor schedules them by hand — and each carries its own rules.

Site initiation

Scheduled directly by the covering monitor, on-site by definition rather than by choice, and limited to one live initiation visit per site.

Out-of-window visits

Recorded as what they are, tagged either as expected by the plan or as ad hoc — a distinction that matters later, when someone asks why a visit sits outside the schedule.

Close-out

Completing it cancels the site's remaining scheduled visits and closes the site to new ones. It cannot complete while another visit at that site is still in progress, so nothing is stranded behind it.

See your monitoring plan operationalized.

Tell us about your study and we'll walk you through it — your plan, your sites.

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