Form: GLP Protocol Deviation and Study Director Impact Assessment

This is a ready-to-use deviation form for a GLP nonclinical study. Use it for any unplanned departure from the protocol or an SOP that has already occurred; use a signed, dated protocol amendment instead for any planned, prospective change to the design. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal document control. A filled specimen follows. Verify each cited regulation against the current source before you rely on it.

When to use this form versus an amendment

	Deviation (this form)	Protocol amendment
Timing	After the event already happened	Before the changed work is done
Nature	Unplanned	Planned, prospective
Example	A dose administered outside the scheduled window because of equipment failure	Adding a recovery group, or changing the high dose before dosing starts
Who signs	Study director’s impact assessment	Study director, as a formal protocol change

Field table

Field	Format	Required	Who completes	When
Deviation ID	Unique ID, tied to the study number	Yes	Study personnel / QAU	On identification
Study number	Text	Yes	Study personnel	On identification
Date of event	Date	Yes	Study personnel	On identification
Description	Text: what happened, which animals/samples/data affected	Yes	Study personnel	Same day as identification
Root cause	Text	Yes	Study personnel, verified by study director	Within a defined turnaround
Affected data	Text, naming the specific records, animals, or time points	Yes	Study personnel	With the description
Impact assessment	Text: effect on study integrity, on the endpoint(s) affected, and on the study’s overall conclusion	Yes	Study director	Before final report finalization
Study director signature and date	Signature, date	Yes	Study director	With the impact assessment
Reported to QAU	Date	Yes	Study personnel or coordinator	Same day as identification
Reflected in final report	Yes / No, with section reference	Yes	Study director	At report finalization

Instructions

Complete the description and affected-data fields the same day the deviation is identified; do not wait for the impact assessment to record what happened.
Notify the QAU the same day; phase-inspection and report-audit coverage depends on the QAU knowing about deviations as they occur, not discovering them at report time.
The study director’s impact assessment must be specific: “no impact” without stated reasoning is not an acceptable assessment. State what was checked and why the deviation does not (or does) affect the endpoint or the conclusion.
Every deviation must be closed, meaning the impact assessment is signed and dated, before the final report is finalized. An open, unassessed deviation at report finalization is a common and citable finding.
Confirm the final report’s “circumstances that may have affected the data” section reconciles to every entry in the deviation log; no deviation should be missing from that reconciliation.
Retain per the study’s records retention schedule, filed with the study archive per 21 CFR 58.190.

Filled specimen

Field	Entry
Deviation ID	DEV-014
Study number	TX-2026-031, 28-day repeat-dose rat toxicology
Date of event	2026-04-12
Description	Group 3 (mid-dose) afternoon dose administered at 16:45 instead of the scheduled 14:00 window
Root cause	Dosing pump failure; replacement pump retrieved and qualified before the affected animals were dosed
Affected data	Day-7 dosing record, Group 3 animals 31-40
Impact assessment	Single delayed dose, well within the 24-hour dosing interval specified in the protocol; toxicokinetic sampling for this group was not scheduled around this dose; no effect on PK or toxicology endpoints assessed
Study director signature and date	[signed] 2026-04-13
Reported to QAU	2026-04-13
Reflected in final report	Yes, Deviations section 8.2

Common inspection findings this form prevents

Deviations that exist only as an informal note, with no study-director impact assessment.
Open, unassessed deviations still on the log when the final report is signed.
A deviation log that does not reconcile to the final report’s description of circumstances affecting the data.
“No impact” assessments with no stated reasoning behind them.
Deviations not reported to the QAU until report time, defeating the QAU’s ability to inspect the affected phase.

How to adapt this form

Set your document number and study-specific fields.
If your facility classifies deviation severity, add a severity field and route critical/major deviations to a faster QAU notification path.
Point the “reflected in final report” field to your actual report template’s deviations section.
Pair with the GLP Study Plan so protocol elements and deviation tracking use consistent terminology.