Subsection 2: Vigilance

For the purposes of this sub-section, the following definitions shall apply 1° Adverse event: any harmful manifestation occurring in a donor, in a person who takes part in research involving the human person carried out within the framework of medically assisted procreation or in a child born or to be born as a result of this medically assisted procreation, whether or not this manifestation is linked to the research or…

The sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions and any serious incidents occurring in France and outside national territory, and to the relevant Committee for the Protection of Individuals those occurring in France during the course of the research, without delay and at the latest within seven days of becoming aware of them. Relevant additional…

The sponsor reports every six months to the Data Protection Committee, in the form of a list accompanied by a summary, any suspected serious unexpected adverse reactions and serious incidents that have occurred in other research that it is conducting in France, or that have occurred outside national territory. The sponsor sends a copy of the six-monthly report mentioned in the previous paragraph to the Director General of the Agence…

The sponsor shall transmit to the investigators concerned any information likely to affect the safety of the donor, the person undergoing medically assisted procreation or the child born or to be born.

The investigator notifies the sponsor of all serious adverse events and serious incidents without delay after becoming aware of them. This notification is the subject of a written report and is followed by further detailed written reports. The investigator notifies the sponsor of adverse events and abnormal test results defined in the protocol as relevant to the evaluation of the safety of the donor, the person undergoing medically assisted reproduction…