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Research DesignFeasibility, aims, hypotheses, methodology, sampling, power and study roadmapping.IRB & Ethics SupportProtocol review, submission readiness, consent materials and continuing-review workflows.Data ManagementeCRF planning, secure data capture, cleaning, coding, metadata and lifecycle governance.Statistics & Data ScienceSample size, statistical programming, modeling, machine learning and reproducible reporting.Evidence SynthesisSystematic reviews, scoping reviews, evidence maps, meta-analysis and bibliometrics.Publication ReadinessEthical academic editing, reporting-guideline checks, figures, references and submission readiness.Telehealth SolutionsScheduling, secure visits, intake, consent, patient engagement and outcome workflows.Medical BillingEligibility, coding review, claims, denials, credentialing and revenue-cycle analytics.

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Home/Research Tools/Protocol Checklist

Free governance tool

Protocol Completeness Checklist

Use a structured review to identify missing protocol components before internal, sponsor or ethics review.

Completion score

0 items

Scientific rationaleBackground establishes the knowledge gapPrimary research question is explicitObjectives and hypotheses are alignedFeasibility constraints are documented

Design and populationStudy design matches the questionEligibility criteria are operationalSampling frame and recruitment are describedSample-size rationale is documented

Outcomes and analysisPrimary outcome and time point are prespecifiedSecondary and exploratory outcomes are distinguishedStatistical analysis plan addresses assumptionsMissing data and sensitivity analyses are planned

Ethics and participantsRisk-benefit assessment is documentedConsent or waiver pathway is justifiedPrivacy and confidentiality safeguards are specifiedAdverse events and protocol deviations have workflows

Data governanceData sources and collection instruments are definedData dictionary or codebook is plannedAccess, de-identification and retention are specifiedQuality control and audit trail responsibilities are assigned

Operations and disseminationRoles, milestones and oversight are definedVersion control and amendment process are definedRegistration or preregistration is addressedReporting guideline and dissemination plan are selected

Completion indicates that an item has been considered, not that the content is scientifically or ethically adequate. Institutional requirements and study-specific regulations may add further elements.

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