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1. Where SoHO entities carry out, in the context of approved clinical-outcome monitoring plans, SoHO clinical studies as referred to in Article 21(3), points (b) and (c), with SoHO preparations that are not yet authorised, the SoHO entities shall comply with the requirements set out in this Regulation and in particular with the standards laid down in Chapters VI and VII.

2. Before commencing a SoHO clinical study for the risk level referred to in Article 21(3), point (c), SoHO entities shall:

(a) apply for a favourable opinion from a relevant ethics committee and shall communicate such an opinion to their SoHO competent authority; such an opinion shall address the ethical, legal and methodological aspects of the SoHO clinical study in order to determine the capacity of the study, as designed, to draw robust conclusions;

(b) await approval by the SoHO competent authority of the clinical-outcome monitoring plan, as referred to in Article 19(2), point (d), and Article 21.

3. When applying SoHO to SoHO recipients in the context of a SoHO clinical study, SoHO entities shall ensure that the intended SoHO recipients, or persons granting consent on their behalf, are informed that the SoHO preparation concerned has not yet been authorised in accordance with this Regulation and that the SoHO preparation is being applied in the context of a SoHO clinical study that forms part of the authorisation process for that SoHO preparation.

4. The person responsible for the SoHO clinical study shall be adequately qualified and trained.

5. In the course of a SoHO clinical study, SoHO entities shall comply with the vigilance and reporting requirements set out in Article 44.