Section 3: Special provisions for research carried out in the context of medically assisted procreation

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…