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of the aforementioned Regulation of 16 April 2014, the same EU trial number as a previous dossier that has lapsed, been withdrawn or that has…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.
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…
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….
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
