Activities of Heide RÜHLE related to 2012/0192(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Amendments (10)
Amendment 74 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘'Substantial modification’': any change to any aspect of the clinical trial, including early termination of the clinical trial and change in number of subjects participating in the trial, which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely tocould have a substantial impact on the safety or rights of the subjects, or on the reliability and robustness of the data generated in the clinical trial;, i.e. change the interpretation of the scientific documents used to support the conduct of the clinical trial, or if the modifications are otherwise significant.
Amendment 84 #
Proposal for a regulation
Article 2 – paragraph 2 – point 30 a (new)
Article 2 – paragraph 2 – point 30 a (new)
(30a) 'Clinical study report': a report containing the full protocol and its eventual subsequent modifications, a statistical analysis plan, summarised efficacy and safety data on all outcomes, and individual anonymised patient data in the format of tabulations or listings.
Amendment 89 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4a An authorisation for a proposed clinical trial by a competent authority of a Member State must be taken after the approval by the concerned ethics committee.
Amendment 110 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. The assessment report shall be submitted through the EU portal and be made publically available.
Amendment 126 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial in the Member State concerned
Amendment 128 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
(bb) infringement of more comprehensive national legislation for clinical trail subject protection, particularly regarding vulnerable persons
Amendment 137 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
The sponsor may withdraw the application at any time until the assessment date. In such a case, the application may only be withdrawn with respect to all Member States concerned. A record of withdrawn applications shall remain in the EU data based and reasons for each withdrawal shall be given.
Amendment 141 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter and if it has been previously approved by an independent Ethics Committee.
Amendment 172 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial and a clinical study report.
Amendment 175 #
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. For the purpose of this Regulation, if a suspended or temporarily halted clinical trial is not restarted, the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial. In the case of early termination, the date of the early termination shall be considered as the date of the end of the clinical trial. After 12 months' of temporary halt, the clinical trial data shall be made publically accessible, even if incomplete.