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How detailed does the Ethics section need to be for an observational trial?

Answer: 

The understanding of ethical concerns should clearly emerge from the proposal. Please check which ethics issues in the ethics issues table (part A/proposal submission form) apply for the activities envisaged in your proposal. The information that needs to be provided in proposal section 5.1 (part B) depends on the ethics issues ticked. The EC guide ‘How to complete your ethics self-assessment’ will exactly guide you through the points to be discussed in proposal section 5.1 for each ethics issue.