Description

<![CDATA[

Plain Language Summary (PLS) Development

Patient-friendly plain language summaries meeting EU Clinical Trial Regulation (CTR) requirements and journal publication standards. Accessible communication of clinical research for lay audiences.

Regulatory Requirements

• EU CTR (536/2014) – Mandatory lay summary requirement
• Health Canada – Plain language summary guidance
• GPP3 – Patient engagement standards
• INVOLVE – Patient involvement in research

PLS Types

• EU CTR Lay Summary – Regulatory requirement for EU trials
• Journal PLS – Publication accompanying summary
• Patient-Facing Results – Study participant communications
• Visual Abstracts – Infographic summaries

Development Process

• Content development at 6th-8th grade reading level
• Flesch-Kincaid readability verification
• Patient reviewer input (optional)
• Visual design and layout
• Translation-ready master

Quality Features

• Jargon-free language
• Clear benefit-risk communication
• Accessible formatting
• Multi-language support

Timeline

Standard: 2-3 weeks | With patient review: 4-5 weeks

]]>