Subsection 1: Appointment of the committee

After submission of the application for clinical trial assessment defined in Article 5(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2004, a Data Protection Committee shall be appointed in accordance with the procedures defined in the first paragraph of II of Article R. 1123-20-1.

Notwithstanding the first paragraph of Article R. 1124-2, the following shall be allocated to the Committee for the Protection of Individuals to which the matter has previously been referred: 1° Clinical trial assessment application dossiers that have, in the Union portal mentioned in Article 80 of the aforementioned Regulation of 16 April 2014, the same EU trial number as a previous dossier that has lapsed, been withdrawn or that has…

The sponsor of a clinical trial, whose application has been submitted under the conditions provided for in 1 of Article 98 of the above-mentioned Regulation of 16 April 2014, may inform the designated personal protection committee within twenty-four hours that this application has already received a favourable opinion from another committee. The designated committee may ask the Minister responsible for health for this file to be allocated to the committee…

The sponsor of a clinical trial which consists of the extension of a previous trial may inform the designated personal data protection committee within twenty-four hours that this trial is linked to a parent study evaluated by another personal data protection committee. The designated committee may ask the Minister for Health to assign this file to the committee that assessed the first parent study.