Subsection 2: Procedure for initial applications for clinical trials on medicinal products

Pursuant to the third paragraph of I of Article L. 1124-1, the personal data protection committees carry out the assessment of Part II provided for in Article 7 of the above-mentioned Regulation of 16 April 2014. The Committee issues a favourable, favourable subject to specific conditions or unfavourable opinion on the clinical trial application. The Committee gives its opinion within the period defined in Article 7(2) of the aforementioned Regulation…

The Committees for the Protection of Individuals forward their unfavourable opinions to the National Commission for Research Involving the Human Person for information.

At the meeting at which the Committee for the Protection of Individuals examines the dossier, the Committee may formulate requests for additional information under the conditions set out in Article 7(3) of the aforementioned Regulation of 16 April 2014. If it requests additional information, the Committee may decide to issue a favourable opinion subject to the answers provided by the sponsor complying with the requirements defined by the Committee and…

At the request of the Committee for the Protection of Individuals, the sponsor or his representative appointed for this purpose, possibly accompanied by the investigator or, where appropriate, the coordinating investigator, may be heard by the Committee. The Committee, by decision of the Chairman, either hears the investigator in plenary or in a restricted committee, or has the investigator heard by the designated rapporteur. This hearing may be conducted by…

When examining the dossier, the Data Protection Committee may provide the competent authority with ethics-related comments on elements falling under Part I provided for in Article 6 of the aforementioned Regulation of 16 April 2014, within 22 days of the date of validation of the application referred to in Article 5(6) of this Regulation. If the competent authority has sent a request for additional information to the sponsor, the personal…