Substantial modifications to clinical investigations
1. If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Chapter II of Annex XV as part of the notification. Changes to the relevant documentation shall be clearly identifiable.
2. The Member State shall assess any substantial modification to the clinical investigation in accordance with the procedure laid down in Article 71.
3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph, unless:
|(a)||the Member State in which the clinical investigation is being or is tobe conducted has notified the sponsor of its refusal based on the |
grounds referred to in Article 71(4) or on considerations of public
health, subject and user safety or health, of public policy, or
|(b)||an ethics committee in that Member State has issued a negative |
opinion in relation to the substantial modification to the clinical
investigation, which, in accordance with national law, is valid for
that entire Member State.
4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.