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ARION
Protocol deviations

Automatic and manual deviations in one reviewable workspace

Out-of-window visits, prohibited medications, missed visits and eligibility waivers raise deviations automatically; review, severity, and CAPA tracking happen alongside manually reported ones.

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How it works

One workspace, whatever raised it

Four rule-engine origins and manual reporting all land in the same record, with the same review, severity and CAPA workflow regardless of how it was raised.

Protocol deviation sources fan into one workspaceFour automatic rule-engine origins -- visit window, prohibited medication, missed visit, and eligibility waiver -- plus manual reporting all fan into a single Protocol Deviation record, which then moves through Review into CAPA tracking.Visit windowauto_visit_windowProhibited medicationauto_prohibited_medicationMissed visitauto_missed_visitEligibility waiverauto_eligibility_waiverManual reportsite or reviewerProtocoldeviationReviewCAPA

Site roles create manual deviations with a restricted origin set; reviewer roles get the full manual origin range.

Four automatic origins

Visit-window, prohibited-medication, missed-visit and eligibility-waiver deviations raise themselves — no one has to remember to log them.

Full CAPA tracking

Title, description, category, severity, CAPA plan and completion date are all editable from the same study-wide detail panel.

Filterable at study scale

Status, category, origin and severity filters, all URL-backed so a dashboard drill-down and a manual filter change share the same state.

See it on your protocol

Bring a protocol or an existing study and we'll show you what this looks like in Arion.

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