10 Amendments of Corinne LEPAGE related to 2012/0192(COD)
Amendment 114 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) In order to follow a given trial from initial ethical approval to final publication, a Universal Trial Registration Number (UTRN) should be assigned to each trial to be conducted in the European Union or whose results are used as part of the Common technical document for a marketing authorisation of a medicinal product.
Amendment 119 #
Proposal for a regulation
Recital 14
Recital 14
(14) It should be left to the Member State concerned to determine the appropriate body or bodies to be involved in this assessment. This decision is a matter of internal organisation of each Member State. Member States, when determining the appropriate body or bodies, should ensure the involvement of lay persons and patients. They should also ensure that the necessary expertise is available. In any case, however, and in accordance with international guidelines, the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. The persons assessing the application should be independent from the sponsor, the institution of the trial site, and the investigators involved, as well as free of any other undue influence. Names, qualifications and declarations of interest of the persons assessing the application should be made publicly available.
Amendment 133 #
Proposal for a regulation
Recital 27
Recital 27
(27) The sponsor should assess the information received from the investigator, and immediately report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the Agency via the electronic database referred to in Article 36.
Amendment 168 #
Proposal for a regulation
Recital 52
Recital 52
(52) The database should contain all relevant information as regards the clinical trial and should be publicly accessible. No personal data of data subjects participating in a clinical trial should be recorded in the database. The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union.
Amendment 173 #
Proposal for a regulation
Recital 59 a (new)
Recital 59 a (new)
(59a) The right of access to documents is recognised by the Charter of Fundamental Rights of the European Union. In particular, Article 42 states the right of access to documents of the institutions, bodies, offices and agencies of the Union, regardless of the medium of the document. Those rules should be upheld.
Amendment 369 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. The names and declarations of interests of the persons validating and assessing clinical trial applications shall be made publicly available.
Amendment 401 #
Proposal for a regulation
Article 14 – paragraph 6 – subparagraph 1 a (new)
Article 14 – paragraph 6 – subparagraph 1 a (new)
The updated assessment report as regard to Part I shall be submitted through the EU portal and made publicly available.
Amendment 440 #
Proposal for a regulation
Article 25 – paragraph 2 – subparagraph 1 – point a
Article 25 – paragraph 2 – subparagraph 1 – point a
(a) a reference to the clinical trial or clinical trials which are substantially modified by using their Universal Trial Registration Number or the registration number in the EU portal;
Amendment 446 #
Proposal for a regulation
Chapter IV a (new)
Chapter IV a (new)
Amendment 604 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least twenty five years after the end of the clinical trial and, where a marketing authorisation has been granted for the investigational medicinal product tested, based on the clinical trial results, throughout the marketing authorisation life of any of the active principles having been investigated. However, the medical files of subjects shall be archived in accordance with national legislation.