100% client-side & Zero-PHI:Data stays in your local browser storage. Client-side processing by design — avoids server-side PHI ingestion. No login required.
Deviation Log Assistant
Turn short notes into a CAPA draft — never put patient identifiers in the free-text notes. Use structured occurrence time and Site ID (for binder print) instead of embedding those in the narrative.
Draft Protocol Deviation Logs Without Risking PHI
Writing up a protocol deviation under time pressure makes it easy to accidentally include a subject identifier, a date that narrows down identity, or other detail that shouldn't be in an administrative log — and once it's written into a CAPA draft, it's hard to walk back.
Deviation Log Assistant helps structure CAPA drafts with built-in PHI guardrails, so the deviation gets documented clearly and consistently without identifying information creeping into fields that should stay administrative.
Drafts stay in your browser's session storage — nothing is sent to a server, no login required, no BAA needed.
Who this is for: CRCs documenting protocol deviations in real time, and site staff standardizing CAPA language across a team.
Kept in this browser's localStorage on this workstation, persisting across restarts, until you clear it or export a backup. Never transmitted to our servers.
Severity
Your site's initial assessment — CRA, sponsor, or IRB may reclassify this after review.
Who is this write-up for?
Documentation details
Neutral fields for CRA-ready logs — classification and status only, not blame. No subject identifiers.
Safety / data-integrity impact?
IRB / regulatory notification needed?
Structured field separate from “who is this write-up for” tone. Reporting thresholds vary by IRB and study type — drug trials fall under 21 CFR 312.66 (investigators must promptly report unanticipated problems involving risk to subjects), while device trials fall under 21 CFR 812.150 (IRB reporting focuses on deviations affecting patient safety or scientific validity; minor deviations still must be recorded even if not IRB-reportable). WCG IRB, for example, only requires prompt reporting for deviations causing subject harm, substantial risk, or unresolved complaints. Always verify against your protocol's specific reporting matrix.
PI sign-off status
Independent of export/print — you can mark Reviewed or Signed without finalizing the whole record.
Has this happened before at this site, within this category (Out-of-Window Visit)?
Your draft write-up
Brief Note to File — what happened, when, fix, status
Defaults to NTF for minor / CAPA for major — override anytime. Not every entry needs a full CAPA.