The subject of a Clinical Investigation (CI) has to give their consent to being the subject of a Clinical Investigation and a record has to be made that consent has been given.

Simplify Understanding

The following information must be explained and presented in a way that the intended subject can understand.

• The nature, objectives, benefits, implications, risks and inconveniences of the CI
• The conditions under which the CI is to be conducted, including the expected duration of the subject’s participation
• The subject’s rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification
• The subject’s right to be informed when a clinical investigation report and a summary have become available in the electronic system
• The possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued
• The damage compensation system referred to in Article 69