Checklist

Methodological Bias & Risk Checklist

Interactive checklist to detect selection, measurement, confounding, analytic, and reporting risks early. Rate residual risk, capture notes, choose mitigations, assign owners and due dates, and save assessments for comparison and tracking across projects.

Interactive Tool

Methodological Bias & Risk Checklist

Use this checklist to evaluate methodological risks across a study or project. For each area, indicate whether issues were identified, rate the residual risk, capture concise notes, and select recommended mitigations. Saved assessments let teams compare risk profiles across projects and over time.

How to use: Complete basic project metadata, work through each bias category, add any study-specific risks, then record recommended actions, owners, and a target date. Be specific in Notes and link to the protocol or analysis plan where possible.

A stable identifier to link this assessment to the study record or protocol.
Short descriptive title.
Person completing this checklist.
ISO date or yyyy-mm-dd.
Phase when this assessment is performed. Different mitigations may apply by phase.
Non-representative sampling, enrollment differences, inclusion/exclusion inconsistencies.
Estimate remaining risk after controls.
1.0 10.0
Concrete examples, affected subgroups, citations to enrollment logs or flowcharts.
Select suggested mitigations to assign.
Instruments, survey wording, observer differences, misclassification.
1.0 10.0
Reliability, validity, calibration, training gaps, gold-standard comparisons.
Mitigations to reduce measurement error.
Unmeasured or uncontrolled confounders, imbalance across arms.
1.0 10.0
Potential confounders, baseline imbalance, DAG references or rationale.
Statistical and design mitigations.
Differential loss to follow-up, patterns of missingness.
1.0 10.0
Missingness mechanism, dropout reasons, balance by group.
Practical mitigations and analyses.
Multiple unplanned analyses, undisclosed data-driven decisions.
1.0 10.0
Exploratory vs confirmatory analyses, undisclosed selective reporting.
Process and technical mitigations.
Underpowered study, unplanned interim looks without correction.
1.0 10.0
Power calculations, assumptions, observed event rates vs assumptions.
Operational and analytic options.
Opaque cleaning, undocumented exclusions, unreproducible code.
1.0 10.0
Where raw data, cleaning scripts, and analysis code are stored; reproducibility issues.
Technical and transparency mitigations.
Outcomes added/removed post hoc, incomplete methods reporting.
1.0 10.0
Differences between protocol and final reporting, undisclosed deviations.
Transparency measures.
Undisclosed COIs, sponsor influence on design/analysis/reporting.
Nature of potential conflicts and any mitigations already in place.
Assessor's overall judgment after considering all categories.
1.0 10.0
List prioritized actions. Be specific about what must change and why.
Person responsible for next steps.
Operational priority for mitigation.
Planned completion date (yyyy-mm-dd).
Paste URLs or repository references to protocols, preregistration, and code.
Any other observations useful to future reviewers.
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