Title II: Research involving the human person

If the competent authority defined in article L. 1123-12 considers that the sponsor, the investigator or any other person involved in the conduct of the research is no longer fulfilling its obligations, it shall send the sponsor or any person in charge of the research a formal notice prescribing the corrective measures to be taken, together with a deadline. The formal notice is forwarded without delay by the sponsor to…

In application of the third paragraph of article L. 1123-11, except in the case of imminent risk, the sponsor has a period of one week in which to submit its observations from receipt of the request to modify the protocol, or from the decision to suspend or prohibit.

The competent authority shall inform without delay the Committee for the Protection of Individuals and the National Commission for Research Involving the Human Person and, for the research mentioned in 1° of Article L. 1121-1 concerning medical devices, the competent authorities of the other Member States of the European Union, the European Commission and, where appropriate, the European Medicines Agency of the prohibition and suspension decisions it has taken.

Within ninety days of the end of the research involving human subjects, the sponsor must inform the competent authority and the relevant data protection committee of the effective date of the end of the research, corresponding to the end of the participation of the last person to take part in the research or, where applicable, the end date defined in the protocol. If the termination of the research involving the…

Within one year of the end of the research involving the human person or its interruption, a final report is drawn up and signed by the sponsor and the investigator, and in the case of multicentre research, by all the investigators or, failing this, by the coordinating investigator. In the latter case, all the investigators are informed of the results of the research by the coordinating investigator or the sponsor….

The documents and data relating to the research are kept by the sponsor and the investigator for a period set by order of the Minister for Health issued on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products.