Clinical Trial Plain-Language Summary Editorial Quality Checklist

Role: Senior Plain-Language Medical Editor and Health Literacy Specialist

Context

• Clinical Trial Identifier: {{trial_name}}
• Therapeutic Area: {{therapeutic_area}}
• Target Reading Grade: {{target_reading_level}}
• Primary Endpoint Findings: {{primary_endpoint_summary}}
• Study Sponsor: {{sponsor_organization}}
• Compliance Framework: {{regulatory_framework}}

Task

Generate a comprehensive editorial audit checklist to verify that the draft plain-language clinical study summary for {{trial_name}} is medically accurate, free of promotional bias, accessible at {{target_reading_level}}, and fully compliant with {{regulatory_framework}} standards.

Method

1. Review the primary endpoint findings from {{primary_endpoint_summary}} to identify high-density medical terminology requiring non-technical translation.
2. Analyze narrative structure against lay communication standards within {{therapeutic_area}} to ensure a logical flow from study rationale to outcome.
3. Formulate inspection checkpoints for medical terminology simplification, verifying each clinical term has a plain-language explanation.
4. Draft verification criteria for numerical and statistical presentation, ensuring percentages, relative risk, and absolute risk are explained without ambiguity.
5. Establish safety disclosure checkpoints that balance positive efficacy statements with fair presentation of adverse events.
6. Construct compliance checks tailored to {{sponsor_organization}} governance and {{regulatory_framework}} transparency requirements.
7. Develop actionable verification items for formatting, visual readability, font hierarchies, and white space utilization.

Constraints

• Checkpoints MUST be phrased as clear, actionable binary verification questions (Yes/No with guidance).
• MUST NOT permit medical jargon without an accompanying lay definition.
• Include explicit guidance for handling statistical significance in layman terms.
• Restrict scope entirely to editorial, health literacy, and compliance auditing.

Output format

• Phase 1: Health Literacy and Reading Level Verification (5-7 checklist items)
• Phase 2: Scientific Accuracy and Endpoint Representation (5-7 checklist items)
• Phase 3: Safety, Adverse Events, and Neutrality Audit (4-6 checklist items)
• Phase 4: Regulatory and Sponsor Compliance Sign-Off (4-5 checklist items)
• Summary Matrix: Remediation priority table categorizing potential defects into Critical, Major, or Minor

Self-review

• Confirm every checkpoint directly references or accommodates {{target_reading_level}} and {{therapeutic_area}} nuances.
• Verify all variables including {{sponsor_organization}} and {{regulatory_framework}} are actively integrated into the evaluation criteria.
• Ensure no overlapping or redundant checkpoints across the four phases.