Protocol Deviation Management
Every protocol deviation, one auditable record.
Vera Deviate™ gives sponsors and CROs a reviewed, signed and locked record of every deviation, without touching your source data.
Free · 10 questions · 5 minutes
What sponsors and CROs get from Vera
ShownCRO-delegated setup. In-house or hybrid? Vera fits how you run your study.
Keep oversight of every deviation
You can delegate the work. You can't delegate the oversight.
- You enter nothing. You just decide.Cases arrive classified, reviewed and evidenced. Sign off or request changes.
- The deviations that can't wait don't wait for the meeting.Route critical categories, such as consent or safety deviations, to a named decision-maker. Everything else waits for review.
- Every decision is its own evidence.Each decision is recorded with a name, role and timestamp, then locked. Export to your eTMF at any time.
- Every source, one record.EDC, site logs and other trackers in one place. Your sources stay put.
Show the oversight you were contracted to deliver
Your sponsor delegated the work. Vera proves you did it.
- Hand over finished cases, not spreadsheets.CRAs enter and classify. CPMs review before the sponsor sees it. Vera enforces independent operational review.
- Every step your team takes is on the record.Each step is logged with a name, role and timestamp. That's proof of delegated oversight for your sponsor and inspectors.
- Every source, reconciled as you go.Import EDC exports, site logs or other trackers. Repeats are skipped on re-import, and missing SOP fields are flagged.
- Catch stalled deviations before the review meeting.See every open deviation's stage and age, and act in time.
- Imported and classifiedSource: site logCRA · 08 Jul 2026, 10:58 UTC
- Operational review: changes requestedAdd CAPAClinical PM · 22 Jul 2026, 09:42 UTC
- CAPA recordedRoot cause, correction, preventionCRA · 29 Jul 2026, 14:05 UTC
- Medical review: more information requestedMedical Monitor · 05 Aug 2026, 09:40 UTC
- Information providedCRA · 12 Aug 2026, 16:20 UTC
- Medical review: concurMedical Monitor · 19 Aug 2026, 10:11 UTC
- Approved for sponsor sign-offClinical PM · 26 Aug 2026, 10:15 UTC
Why Vera?
Built for messy reality
Deviations live in EDC, site logs and people's heads. Vera turns them into one auditable record, without touching your source data.
Your process, not ours
Built by clinical operations people and configured to your SOPs, categories and roles. There's no generic template to bend your study around.
People decide. Vera proves it.
No AI makes the call. Every decision is made by a named person, recorded with a timestamp, then locked, so it's audit-ready.
Could you show an inspector how you oversee deviations you've delegated?
10 inspector questions. See your gaps and what to ask your CRO.
Free · 5 minutes
How each question is tagged
- FDA regulationBinding law: informed consent and IRB rules (21 CFR 50 and 56)
- ICH E6(R3)Expected under the current GCP standard
- FDA guidanceRecommended in FDA’s draft guidance on protocol deviations
- Good practiceSupports a regulatory goal; how you meet it is up to you
Sources are listed at the end of the self-check.
0 of 10 answered
Your score
/ 10
Your study looks like the ones Vera was built for: deviations from several sources, assessments the EDC can't hold, and critical decisions that can't wait.
Your gaps, most weight first
This self-check is a conversation starter, not an audit or a regulatory assessment. Tags show where each question connects to FDA regulations, ICH E6(R3) or FDA’s December 2024 draft guidance on protocol deviations, which is nonbinding. Bionabu is not affiliated with or endorsed by FDA or ICH.
Sources · Last checked: 1 Oct 2026
ICH E6(R3) Good Clinical Practice: principles and Annex 1 in effect in the EU since 23 July 2025. Annex 2 (decentralised, pragmatic and real-world data trials) was adopted in June 2026 and takes effect on 15 January 2027.
FDA draft guidance Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices (December 2024, docket FDA-2023-D-5016). As of Oct 1, 2026, FDA lists it as current draft guidance, with no newer final or revised version. FDA regulations: 21 CFR 50 and 21 CFR 56.
Bring us one protocol
Free · 10 questions · 5 minutes
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