A protocol deviation is any departure from the approved protocol, and ICH E6(R3) now expects that tracking to connect directly to your risk-based quality management, not sit in a separate spreadsheet. Capture's edit checks, auto-queries and field-level audit trail already give you that link, from form field to deviation to resolution.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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R3
ICH E6(R3) formally expects deviation tracking tied to risk assessment
Auto
query raised the moment an edit check catches a deviation-causing value
Field-level
audit trail: who, what, when, why, on every change
0
separate deviation-log spreadsheet needed
The standard
ICH E6(R3) frames protocol deviations as part of risk-based quality management, not a compliance afterthought: sponsors are expected to identify important deviations, understand why they happened, and feed that back into how the study is monitored, rather than just logging them for an end-of-study summary. That expectation works best when a deviation is tied to the actual data and field that triggered it.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
How it works in Capture
Attach a range, comparison or custom rule to any field on your CRF. The moment a site enters a value outside a visit window, a dosing rule, or another protocol-defined limit, Capture raises a query automatically, tied to that exact field and subject, with your own message template filled in.
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The difference
Before you switch
Edit checks, auto-queries and the audit trail are part of every plan, including the free sandbox.
Capture does not certify or automatically classify deviations as major or minor; that judgment is your team's, applying your own protocol and risk assessment to the flagged records.
Edit checks are added field by field in the same builder used for the rest of the CRF.
Bring an existing deviation log across as reference data while new deviations flow through edit checks going forward.
Email support, typically under 24 hours, plus documentation on Enterprise.
Free sandbox with every feature. No credit card, no sales call.
No. Capture raises an auto-query when an edit check catches a value that breaks a rule, tied to that exact field and subject. That query, and its resolution in the audit trail, is the record you classify and log as a deviation.
R3 frames deviation tracking as part of risk-based quality management: identify important deviations, understand why they happened, and feed that into ongoing monitoring, rather than a static end-of-study log.
Yes. By-site and date-range filtering, plus CSV/Excel exports with an automatic data dictionary, let you pull every flagged item for a review.
No. Edit checks catch anything expressible as a range, comparison or custom rule on a field. A deviation outside the data itself, like a missed visit with no data entered, still needs a human process to flag.
Yes. That page covers the audit trail generally; this page focuses specifically on the deviation-tracking use case built from edit checks and queries.
Yes. The free sandbox includes every feature with sample data, no credit card required.
Keep exploring
Query management software
The auto-query mechanism deviation tracking is built on.
ICH E6(R3) guide
The risk-based quality management standard behind this expectation.
Audit trail software
The field-level history every deviation resolution is recorded in.
Risk-based monitoring and SDV software
How flagged records feed into a monitoring plan.
ALCOA+ data integrity checklist
The data-integrity principles behind a clean deviation record.
Free sandbox with every feature. No credit card, no sales call.