Protocol deviation classification record
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StatMedAnalysis | Original downloadable worksheet | 6 November 2026

Classify deviations consistently without selecting exclusions based on results.

How to use this worksheet
Define deviation categories and their possible consequences before unblinded review
where feasible. Distinguish treatment adherence, eligibility, data quality and
administrative issues. Record actual timing of decisions and relate each deviation to
the estimand and analysis plan. Preserve all decisions and their reasons.

Save a working copy and keep the original blank version. Use public, hypothetical or
aggregate information only; do not enter patient identifiers, credentials or confidential
records. Keep source evidence in your approved project workspace. Mark unresolved text
fields UNKNOWN or NOT REPORTED with a reason; never substitute zero for an unknown count.

Project/version __________________  Prepared by role/date __________________

Working fields
1. Deviation category and definition
Response/evidence: _________________________________________________________
___________________________________________________________________________

2. Protocol requirement affected
Response/evidence: _________________________________________________________
___________________________________________________________________________

3. Discovery date and available results
Response/evidence: _________________________________________________________
___________________________________________________________________________

4. Potential data or estimand impact
Response/evidence: _________________________________________________________
___________________________________________________________________________

5. Prespecified handling rule
Response/evidence: _________________________________________________________
___________________________________________________________________________

6. Proposed action and rationale
Response/evidence: _________________________________________________________
___________________________________________________________________________

7. Analysis-set consequence
Response/evidence: _________________________________________________________
___________________________________________________________________________

8. Review and reporting location
Response/evidence: _________________________________________________________
___________________________________________________________________________

Hypothetical worked case
A fictional missed visit is a protocol deviation and creates a missing outcome.
Automatically excluding the participant from all analyses would add an analysis decision
that needs its own justification.

Decision rule and limitations
Do not equate any deviation with exclusion. Apply consistent prespecified rules where
appropriate and disclose later decisions and their possible bias.

Decision _______________________  Remaining uncertainty ____________________
Next action ____________________  Owner / review date ______________________
Independent check and discrepancy resolution _______________________________

Official method or reporting reference checked 6 November 2026
https://www.consort-spirit.org/

This is an original planning aid, not an official checklist, validated instrument,
clinical recommendation or certificate of expert approval. Apply the referenced
guidance to the specific design and record any additional requirements.