Subsection 3: Application for substantial modification

When an application for a substantial amendment to an initial clinical trial is submitted, the competent Committee for the Protection of Individuals shall carry out the Part II assessment provided for in Article 7 of the aforementioned Regulation of 16 April 2014 within the time limits defined in Article 20 of that Regulation. The Committee shall issue a favourable, favourable subject to specific conditions or unfavourable opinion on this application….

Applications for substantial amendments are subject to a simplified assessment procedure. These applications are examined by a select committee made up of two representatives from each of the colleges mentioned in Article R. 1123-4, including at least one person qualified by virtue of their expertise in biostatistics or epidemiology, and the Chairman or, in his absence, the Vice-Chairman. The Select Committee shall meet, including by means of a telephone or…

When the Committee for the Protection of Individuals examines an application for a substantial amendment, the Committee may provide the competent authority with ethically-related comments on elements falling under Part I provided for in Article 6 of the aforementioned Regulation of 16 April 2014 within 15 days of the date of validation of the application referred to in Article 17(5) of this Regulation. If the competent authority has sent a…

For requests for substantial changes to the list of investigation sites or principal investigators, the Chairman issues the opinion on behalf of the Committee on the proposal of a single rapporteur.