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Review Checklist: [Deliverable Type]

Overview

Deliverable: [What is being reviewed] Source materials: [List the source documents used] AI tools used: [List any AI tools or workflows used] Risk tier: [Low / Medium / High] Reviewer: [Name] Date: [Date]

Source accuracy

  • All factual claims are supported by the cited source material
  • Numerical data (endpoints, p-values, confidence intervals, sample sizes) are accurately reproduced
  • Study design and population descriptions match the source
  • Timepoints and study phases are correctly represented
  • Statistical significance and clinical significance are correctly distinguished
  • Conclusions align with the source’s stated conclusions, not AI interpretation

Completeness

  • All relevant efficacy findings are included
  • Safety data is present and not minimised or omitted
  • Study limitations are preserved
  • Relevant qualifiers are retained (subgroup, post-hoc, exploratory, interim)
  • Comparator details are accurate and included

Unsourced content

  • No claims appear that cannot be traced to the provided source materials
  • Background information comes from appropriate, verifiable sources
  • No AI-generated content has been left in that was not verified against a source
  • Definitions or explanations are accurate and appropriate for the audience

Language and appropriateness

  • Language is appropriate for the target audience
  • Medical terminology is used correctly and consistently
  • No inappropriate certainty (e.g., “proves” instead of “demonstrated”)
  • No inappropriate hedging that understates clear findings
  • Tone is consistent and professional

Compliance (where applicable)

  • Claims are within the approved messaging framework
  • References are correctly cited and support the claims made
  • No off-label implications or suggestions
  • Balance of efficacy and safety information is appropriate
  • Fair balance requirements are met (for promotional content)
  • Prescribing information requirements are addressed (for promotional content)

Format and structure

  • Deliverable meets the specified format requirements
  • Headings, structure, and flow are logical
  • Length is within the specified range
  • All required sections are present

AI-specific checks

  • AI-assisted sections have been specifically reviewed for accuracy
  • No hallucinated data, references, or citations
  • No blended or merged findings from different sources or study arms
  • No extrapolated conclusions beyond what the source supports
  • AI outputs have been compared against the original source, not just reviewed for readability

Review outcome

  • Approved — content meets all requirements
  • Approved with minor changes — changes noted and implemented
  • Requires revision — significant issues identified, returned for rework
  • Rejected — fundamental accuracy or compliance issues

Notes

[Space for reviewer comments, specific issues found, or changes requested]
Reviewer signature: _______________ Date: _______________