Module232025

07/05/2025

Ethics Guideline published 18 Sept. 2017, EudraLex Vol 10 https://ec.europa.eu/health/sites/healt h/files/files/eudralex/vol 10/2017_09_18_ethical_consid_ct_with _minors.pdf §9.1 To ensure feasibility of trials to be performed, it is recommended that the trial design be set up following consultation of the patients from age groups to be involved in the trial (in older children or adolescents) or from patient representatives. Gaining the child’s assent

Documents 40+ pages Reading age 25+ (or post doc standard) 8-10 pages of Data Privacy language

The Organisation for Professionals in Regulatory Affairs

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Information Sheets –an opportunity?

Readability Scoring: https://www.readabilityformulas.com/free-readability-formula-tests.php Clinical Trial Regulation, Preamble (30): Prior to obtaining informed consent, the potential subject should receive information in a prior interview in a language which is easily understood by him or her. 8-14 years Information Sheet

• Flesch Reading Ease score: 51.9: fairly difficult to read • Gunning Fog: 13.9: hard to read • Flesch-Kincaid: 12th Grade (16-17 y.o) • Coleman-Liau Index: 10th Grade (14-15 y.o.) • SMOG* Index: 11th Grade (15-16 y.o.) • Automated Readability Index: 18-19 yrs. old ( college level entry ) • Linsear Write Formula : college graduate and above

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