Module 5 Presentations

19/07/2024

Form of Information

● Tone (invitation) ● Content (short but comprehensive and relevant, clear and understandable to a lay person) ● Opportunity to ask questions/ reflect ● Updates (iterative process; N.B. ADRs) ● Consent subject to approval by ethics committee

The Organisation for Professionals in Regulatory Affairs

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Information requirements

• Information to be provided - Regulation No 536/2014/EU Art 29 • the nature of clinical trial including risks and inconveniences; • subject's rights and guarantees regarding his or her protection, e.g. right to refuse to participate and the right to withdraw at any time • the conditions under which the trial will be conducted, including duration of participation • possible treatment alternatives and arrangements if participation is discontinued • Compensation, payments and expenses • Summary results to be published on database

The Organisation for Professionals in Regulatory Affairs

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