Activities of António Fernando CORREIA DE CAMPOS related to 2012/0192(COD)
Plenary speeches (1)
Clinical trials on medicinal products for human use (debate)
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 (91)
Amendment 42 #
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and, rights and well-being of subjects should be protected and the data generated should be relevant, reliable and robust.
Amendment 43 #
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation. The conduct of a clinical trial should be conditioned to prior approval by an Ethics Committee.
Amendment 49 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) Whereas most clinical trials are implemented for the assessment of therapies consisting of large samples of patient populations, the present Regulation should not discriminate patients suffering from rare and ultra- rare diseases and should integrate the specificities of low-prevalence conditions when assessing a trial.
Amendment 55 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – introductory part
Article 2 – paragraph 2 – point 3 – introductory part
(3) ‘Low-intervention clinical trial’: a clinical trialstudy which fulfils all of the following conditions:
Amendment 58 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 61 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial; and a low interventional clinical trial as defined in Article 2 (2) and (3), respectively.
Amendment 63 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’'Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; in accordance with the current reliable scientific evidence; (This amendment applies throughout the text.)
Amendment 64 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10 a (new)
Article 2 – paragraph 2 – point 10 a (new)
(10a) 'Ethics Committee': an independent body in a Member State, which includes healthcare professionals, laypersons and at least one well-experienced knowledgeable patient or patient representative, for the review of the scientific, medical and ethical aspects of a clinical trial and whose responsibility is to protect the rights, safety and well-being of subjects and to provide public assurance of that protection.
Amendment 65 #
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘Sponsor’: an individual, company, institution or organisation which takes responsibility for the initiation and, management and/or financing of the clinical trial;
Amendment 66 #
Proposal for a regulation
Article 2 – paragraph 2 – point 15
Article 2 – paragraph 2 – point 15
(15) ‘'Subject’': an individual who freely and voluntarily participates in a clinical trial, either as recipient of an investigational medicinal product or as a control;
Amendment 67 #
Proposal for a regulation
Article 2 – paragraph 2 – point 19
Article 2 – paragraph 2 – point 19
(19) ‘'Informed consent’': a process by which a subject freely and voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate;
Amendment 71 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2
Article 3 – paragraph 1 – indent 2
– the data generated in the clinical trial are going to be relevant, reliable and robust.
Amendment 73 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4a Role of and guidelines for Ethics Committees 1. An authorisation for the conduct of a clinical trial by a competent authority of a Member States may be given after and only if the concerned Ethics Committee has given its approval. 2. The Commission shall, within one year, come forward with guidelines for Member States on Ethics Committees in order to streamline procedures and make it easier to conduct trials in several Member States, without compromising the safety of subjects.
Amendment 74 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 75 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 77 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within sixfifteen days following submissionthe appointment of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 80 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, and the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 82 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threfive days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 84 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 2
Article 6 – paragraph 1 – point a – point i – indent 2
– the relevance and acceptability of the clinical trial, taking account of the current state of scientific knowledge, and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products;
Amendment 85 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial and, methodology (including sample size and randomisation, comparator and endpoints); and the prevalence of the condition, especially for rare diseases (which affect no more than five persons per 10 000), and ultra-rare diseases (which meet a prevalence threshold of no more than one affected person per 50 000).
Amendment 86 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 2
Article 6 – paragraph 1 – point a – point ii – indent 2
– the characteristics of the intervention compared to normal clinical practicethe best current proven intervention;
Amendment 87 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
- the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options
Amendment 89 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
The reporting Member State shall submit Part I of the assessment report, including its conclusion, already comprising the views of the concerned Ethics Committee, to the sponsor and to the other Member States concerned within the following time periods:
Amendment 91 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 120 days from the validation date for low-intervention clinical trials;
Amendment 93 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 235 days from the validation date for clinical trials other than low- intervention clinical trials;
Amendment 95 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 3045 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 98 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account. and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, the reasons for such deviation shall be stated in the assessment report.
Amendment 104 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) compliance with the requirements for the protection of subjects and informed consent as set out in Chapter V;
Amendment 105 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
(aa) compliance with national legislative provisions related to ethics.
Amendment 106 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Each Member State concerned shall complete its assessment within twenty days from the validation date. It may request, with justified reasons, additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period.
Amendment 107 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within ten days from the assessment date or the last day of the assessment referred to in Article 7, whichever is later.
Amendment 109 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Where the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the clinical trial, provided that it was considered a low-intervention clinical trial in accordance with Article 5(2).
Amendment 110 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. TFor the purposes of this Article, the Member States concerned shall not request additional explanations from the sponsor after the assessment date.
Amendment 111 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In addition, the views of the concerned Ethics Committee shall be taken into account.
Amendment 113 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the decision shall be limited to the aspects covered by Part I of the assessment report.
Amendment 114 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor mayshall apply for an authorisation limited to aspects covered by Part II of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision with regard to Part II of the assessment report in accordance with Article 8. Failure in approval granting on any of the Parts I and II of the application file results in refusal of the authorization of the clinical trial.
Amendment 115 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
This Chapter is without prejudice to the possibility for the sponsor to submit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned. That application shall be considered as a new application for authorisresubmission of the application. It must be accompanied by any previous assessment report, by the considerations of another clinical trialconcerned Members States, and it must highlight the changes or the reasons justifying the resubmission of the application file.
Amendment 120 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 123 #
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 124 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused. Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within fifteen days from the assessment date.
Amendment 125 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 126 #
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision already comprising the views of the concerned Ethics Committee, within tfifteen days from the validation date.
Amendment 127 #
Proposal for a regulation
Article 20 – paragraph 7
Article 20 – paragraph 7
7. Where the Member State concerned has not notified the sponsor of its decision within the time periods set out in paragraphs 5 and 6, the substantial modification shall be considered as authorised, provided that it was considered a low-intervention clinical trial in accordance with Article 5(2).
Amendment 128 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered by Part II of the assessment report within tfifteen days from the validation date according to the procedure as referred to in Article 7(1).
Amendment 129 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date or the last day of the assessment referred to in Article 22, whichever is later.
Amendment 130 #
Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 131 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the substantial modification provided that it remains a low-intervention clinical trial in accordance with Article 5(2).
Amendment 133 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to amendcomplete Annexes I and II with the objective to adapt them to technical progress or to take account of global regulatory developments.
Amendment 138 #
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Written information given to the subject and/or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise, clear, relevant, and understandable to a lay person. It shall include both medical and legal information that shall be explained orally by a medical doctor to the subject. It shall inform the subject about his or her right to revoke his or her informed consent.
Amendment 139 #
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the research protocol has been endorsed by an Ethics Committee, with expertise in the relevant disease;
Amendment 140 #
Proposal for a regulation
Article 31 – paragraph 1 – point h a (new)
Article 31 – paragraph 1 – point h a (new)
(ha) The research protocol has been endorsed by an Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics;
Amendment 143 #
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, the clinical study report (CSR) and the full dataset of clinical trial data. These elements shall be made publicly accessible through the EU database.
Amendment 145 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
Article 34 – paragraph 3 – subparagraph 2
Amendment 147 #
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's data shall be submitted to the EU database and made publicly accessible, even if incomplete.
Amendment 149 #
Proposal for a regulation
Article 37 – paragraph 2
Article 37 – paragraph 2
2. The investigator shall immediately report serious adverse events to the sponsor, to the Agency and to the competent authority of the concerned Member States, unless the protocol provides, for certain adverse events, that no reporting is required. The investigator shall record all serious adverse events. Where necessary, the investigator shall send a follow-up report to the sponsor.
Amendment 151 #
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 fivetwenty years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.
Amendment 153 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
Any sponsor may delegate any or all of its logistic tasks to an individual, a company, an institution or an organisation. Such delegation shall be without prejudice to the scientific and ethical responsibility of the sponsor.
Amendment 166 #
Proposal for a regulation
Annex 2 – part 4 – point 4 – indent 2 a (new)
Annex 2 – part 4 – point 4 – indent 2 a (new)
- the rationale for the modification proposed;
Amendment 167 #
Proposal for a regulation
Annex 3 – part 1 – point 4 a (new)
Annex 3 – part 1 – point 4 a (new)
4a. The sponsor shall keep detailed records of all adverse events reported to it by the investigator(s) and register them in the EU portal.
Amendment 199 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – introductory part
Article 2 – paragraph 2 – point 3 – introductory part
(3) ‘Low-intervention clinical trialstudy’: a clinical trial which fulfils all of the following conditions: (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 209 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 215 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial and a low interventional clinical trial as defined in Article 2, second paragraph, points (2) and (3), respectively;
Amendment 218 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; in accordance with the current reliable scientific evidence; (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 261 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 263 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 268 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within sixfifteen days following submission of the application dossier, the proposed reportingappointment, this Member State shall notify the sponsor through the EU portal of the following:
Amendment 274 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, and the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 281 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threfive days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 309 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. The reporting Member State shall submit Part I of the assessment report, including its conclusion, already comprising the views of the concerned Ethics Committee, to the sponsor and to the other Member States concerned within the following time periods:
Amendment 311 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 120 days from the validation date for low-intervention clinical trials;
Amendment 314 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 235 days from the validation date for clinical trials other than low- intervention clinical trials;
Amendment 318 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 3045 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 320 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, the reasons for such deviation shall be stated in the assessment report.
Amendment 341 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Each Member State concerned shall complete its assessment within twenty days from the validation date. It may request, with justified reasons, additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period.
Amendment 349 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision already comprising the views of the concerned Ethics Committee, within ten days from the assessment date or the last day of the assessment referred to in Article 7, whichever is later.
Amendment 363 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the clinical trial, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 374 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In addition, the views of the concerned Ethics Committee shall be taken into account.
Amendment 389 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the decision shall be limited to the aspects covered by Part I of the assessment report.
Amendment 390 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor mayshall apply for an authorisation limited to aspects covered by Part II of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision with regard to Part II of the assessment report in accordance with Article 8. Failure in granting approval on either Part I or II of the application file shall result in refusal of the authorization of the clinical trial.
Amendment 400 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 411 #
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 420 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date.
Amendment 421 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 426 #
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the validation date.
Amendment 427 #
Proposal for a regulation
Article 20 – paragraph 7
Article 20 – paragraph 7
7. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods set out in paragraphs 5 and 6, the substantial modification shall be considered as authorised, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 430 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered by Part II of the assessment report within tfifteen days from the validation date, according to the procedure referred to in Article 7, paragraph 1.
Amendment 432 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date or the last day of the assessment referred to in Article 22, whichever is later.
Amendment 434 #
Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the substantial modification of the clinical trial.
Amendment 435 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the substantial modification. , provided that it remains a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 530 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. 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, the clinical study report (CSR) and the full dataset of clinical trial data. These elements shall be made publicly accessible through the EU database.
Amendment 602 #
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 fivetwenty years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.