76 Amendments of Margrete AUKEN related to 2012/0192(COD)
Amendment 80 #
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, and approval by an ethics committee prior to commencement.
Amendment 83 #
Proposal for a regulation
Recital 3
Recital 3
(3) The existing definition of a clinical trial as contained in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use should be clarified. For that purpose, the concept of clinical trial should be more precisely defined by introducing the broader concept of ‘clinical study’ of which the clinical trial is a category. That category should be defined on the basis of specific criteria. This approach takes due account of international guidelines, and is in line with the EU legislation governing medicinal products, which builds on the dichotomy of ‘clinical trial’ and ‘non- interventional study’.
Amendment 92 #
Proposal for a regulation
Recital 8
Recital 8
(8) The timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file, while ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials. Against this background, Directive 2001/20/EC introduced the concept of tacit authorisationimplicit authorisation if there has been a vote in favour by the ethics committee and the competent authority has not objected within the deadline. This concept should be maintained in order to ensure that timelines are adhered to. In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly. NIn the event of a public health crisis no minimal timelines for approval should therefore be established.
Amendment 182 #
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – introductory part
Article 2 – paragraph 2 – point 1 – introductory part
(1) ‘Clinical studytrial’: any investigation in relation to humans intended (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 185 #
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – point c a (new)
Article 2 – paragraph 2 – point 1 – point c a (new)
(ca) to conduct a post-marketing safety or post-marketing efficacy trial on a medicinal product authorised within the last 10 years.
Amendment 186 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2
Article 2 – paragraph 2 – point 2
Amendment 203 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a
Article 2 – paragraph 2 – point 3 – point a
(a) the investigational medicinal products arehave been authorised for more than 10 years;
Amendment 210 #
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 anyll of the Member States concerned;
Amendment 214 #
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; study where the medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorisation and where the assignment of the patient to a particular therapeutic strategy falls within current practice and is not decided in advance by a trial protocol; the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Amendment 219 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6 a (new)
Article 2 – paragraph 2 – point 6 a (new)
(6 a) Best current proven intervention: a standard based on the most current proven scientific knowledge and evidence;
Amendment 223 #
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 a 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; or could change the interpretation of the scientific documents used to support the conduct of the trial, or any other change to any aspect of the clinical trial that is otherwise significant.
Amendment 226 #
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 237 #
Proposal for a regulation
Article 2 – paragraph 2 – point 20
Article 2 – paragraph 2 – point 20
(20) ‘Protocol’: a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial; the term protocol refers to the protocol, successive protocols and protocol amendments;
Amendment 241 #
Proposal for a regulation
Article 2 – paragraph 2 – point 30 b
Article 2 – paragraph 2 – point 30 b
(30b) 'Clinical study report': a report containing all results and all the supporting data, including 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 that is easily searchable;
Amendment 250 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2 a (new)
Article 3 – paragraph 1 – indent 2 a (new)
- the data generated in the clinical trial address a documented gap in scientific knowledge that could not be acquired through other means.
Amendment 253 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 254 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4a Ethics Committee An authorisation for the conduct of a clinical trial by a competent authority of a concerned Member States can be granted only if the concerned Ethics Committee has given its approval.
Amendment 255 #
Proposal for a regulation
Article 4 b (new)
Article 4 b (new)
Article 4b Toxicological experiment Protection of the trial subjects shall be safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial involving the use of a non-authorised investigational medicinal product.
Amendment 260 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 270 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) whether it is the reporting Member State or which other Member State concernedo is the reporting Member State;
Amendment 272 #
Proposal for a regulation
Article 5 – paragraph 2 – point e (new)
Article 5 – paragraph 2 – point e (new)
(e) the clinical trial registration number in the EU Portal.
Amendment 275 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposappointed 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, the clinical trial shall be considered a low-intervention clan explanation for the delay shall be submitted through the EU portal with an indical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member Statetion of when the notification will be given.
Amendment 278 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposappointed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within three 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 Regulointed Member State shall submit an explanation, the clinical trial shall be considered as a low-intervention clrough the EU portal with an indical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member Statetion of when the notification will be given.
Amendment 284 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the time periods referred to in paragraphs 2 and 4.
Amendment 289 #
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 of the clinical trial, including assurance that the groups of subjects participating in the trial represent the population to be treated in terms of age, gender and whether the subjects are healthy, volunteers or patients, as well as taking account of the current state of scientific knowledge, best current proven intervention 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 295 #
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, based on pre-determined primary outcome parameters, taking account of statistical approaches, design of the trial and methodology (including sample size and pre-determined sub-groups allowing for a stratified analysis by age and gender and randomisation, comparator and endpoints);
Amendment 310 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
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, it shall state the reasons for this deviation in the assessment report.
Amendment 322 #
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 to the EU database and made publicly available.
Amendment 334 #
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 the subjects and informed consent as set out in Chapter V;
Amendment 337 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point e a (new)
Article 7 – paragraph 1 – subparagraph 1 – point e a (new)
(ea) compliance with Article 46a;
Amendment 355 #
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) refusal of the Ethics Committee to approve the conduct of the clinical trial in the Member State concerned;
Amendment 375 #
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, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 380 #
Proposal for a regulation
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3a. The Commission shall, within one year following the entry into force of this Regulation, publish guidelines for Member States on Ethics Committees in order to streamline procedures and facilitate the conduct of trials in several Member States, without compromising the safety of subjects.
Amendment 386 #
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. Where national provisions on the protection of clinical trial subjects are more comprehensive than the provisions of this Regulation, the most protective measure shall apply.
Amendment 387 #
Proposal for a regulation
Article 11
Article 11
Amendment 404 #
Proposal for a regulation
Article 14 – paragraph 6 – subparagraph 5 a (new)
Article 14 – paragraph 6 – subparagraph 5 a (new)
The updated assessment report as regard to Part I shall be submitted through the EU portal to the EU database and made publicly available.
Amendment 405 #
Proposal for a regulation
Article 14 – paragraph 7
Article 14 – paragraph 7
7. The additional Member State concerned shall assess, for its territory, the aspects relating to Part II of the assessment report within ten days of the date of submission of the application referred to in paragraph 1. Within this time period it may request, with justified reasons, additional explanations from the sponsor regarding aspects relating to Part II of the assessment report as far as its territory is concerned.
Amendment 406 #
Proposal for a regulation
Article 14 – paragraph 10
Article 14 – paragraph 10
10. Where the additional Member State concerned has not notified the sponsor of its decision within the relevant time period referred to in paragraph 3, the conclusion on Part I of the assessment report shall be considered as the decision of the additional Member State concerned on the application for authorisation of the clinical trialadditional Member State shall submit an explanation through the EU portal with an indication of when the notification will be given.
Amendment 409 #
Proposal for a regulation
Article 15
Article 15
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 approved by an independent ethics committee before its implementation.
Amendment 412 #
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 414 #
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Where the reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the substantial modification applied for shall be considered as concerning an aspect covered by Part I of the assessment report, reporting Member State shall submit an explanation through the EU portal withe appln indication shall be considered as complete and,of wheren the clinical trial is a low-intervention clinical trial, it shall be considered as remaining a low- intervention clinical trial after its substantial modificationotification will be given.
Amendment 416 #
Proposal for a regulation
Article 17 – paragraph 4 – subparagraph 3
Article 17 – paragraph 4 – subparagraph 3
Where the reporting Member State has not notified the sponsor according to points (a) to (c) of paragraph 2 within three days following receipt of the comments or of the completed application, the application shall be considered complete and, where the clinical trial is a low-intervention clinical trial, that it will remain a low- intervention clreporting Member State shall submit an explanation through the EU portal with an indical trial after its substantial modificatiotion of when the notification will be given.
Amendment 418 #
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. 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.
Amendment 419 #
Proposal for a regulation
Article 18 – paragraph 4 a (new)
Article 18 – paragraph 4 a (new)
4a. The assessment report shall be submitted through the EU Portal to the EU database and made publicly available.
Amendment 422 #
Proposal for a regulation
Article 19 – paragraph 3 a (new)
Article 19 – paragraph 3 a (new)
3a. Where, regarding Part I of the assessment report, the substantial modification is acceptable or acceptable subject to conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report.
Amendment 423 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where the Member State concerned has not notified the sponsor within the time period referred to in paragraph 1, the substantial modification applied for shall be considered as concerning an aspect covered by Part II of Member State concerned shall submit an explanation through the EU portal withe assessment report and the appln indication of when the notification shawill be considered as completegiven.
Amendment 424 #
Proposal for a regulation
Article 20 – paragraph 3 – subparagraph 3
Article 20 – paragraph 3 – subparagraph 3
Where the Member State concerned has not notified the sponsor according to points (a) and (b) of paragraph 1 within three days following receipt of the comments or of the completed application, the substantial modification shall be considered as concerning an aspect covered by Part II of the assessment report and the applMember State concerned shall submit an explanation through the EU portal with an indication of when the notification shawill be considered as completegiven.
Amendment 425 #
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 within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 428 #
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 authorisedMember State concerned shall submit an explanation through the EU portal with an indication of when the notification will be given.
Amendment 429 #
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 ten days from the validation date according to the procedure referred to in Article 7(1).
Amendment 431 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. During the time period referred to in paragraph 1 the Member State concerned may request, with justified reasons, additional explanations from the sponsor regarding this substantial modification as far as its territory is concerned.
Amendment 433 #
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 in the Member State concerned;
Amendment 436 #
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 covMember State concerned by Part I of the assessment report shall be considered as the decision of the Member State concerned on shall submit an explanation through the EU portal withe appln indication for authorisation of the substantial modificatioof when the notification will be given.
Amendment 439 #
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 the registration number in the EU portal;
Amendment 460 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 461 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively informed of the nature, duration, significance, implications and risks of the clinical trial. I, including whether the clinical trial has to be discontinued, the eventual treatment alternatives, and any other information, as provided for in national legislation. Information shall also be given orally with the opportunity to ask questions, and the subject shall be provided with comprehensive information in writing which he or she is allowed to keep. Adequate time shall be given to the subject to consider his or her decision. The information provided and the informed consent shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness, trustful for the subject, may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given. The following information shall systematically be indicated on the document by which informed consent is given: a. The trial registration number in the EU portal, and b. A statement that the results will be made available in the EU portal within one year after completion of the trial, together with the indication of the approximate date.
Amendment 474 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 476 #
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is considershall be followed by the investigator;
Amendment 491 #
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 533 #
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 trialll results and all the supporting data of the clinical trial in the form of a complete clinical study report; the report shall be easily searchable.
Amendment 536 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
Article 34 – paragraph 3 – subparagraph 2
However, where, for justified scientific reasons, it is not possible to submit a summary of the results within one year, the summary of resultsthe full study report with all results and all the supporting data within one year, it shall be submitted as soon as it is available. In this case, the protocol shall specify when the results are going to be submitted, together with an explanationfull clinical study report with all results and all supporting data is going to be submitted, together with a justification. The justification shall be made publicly accessible in the EU database.
Amendment 542 #
Proposal for a regulation
Article 34 – paragraph 3 a (new)
Article 34 – paragraph 3 a (new)
3a. In case of non-compliance by the sponsor with the obligation referred to in paragraph 3, harmonised penalties shall be enforced by the concerned Member States. The amount shall be up to 7 000 EUR for the 30 first day of non- compliance and up to 7 000 EUR per each additional delay day until compliance.
Amendment 548 #
Proposal for a regulation
Article 36 – paragraph 1
Article 36 – paragraph 1
The European Medicines Agency established by Regulation (EC) No 726/2004 (hereinafter, the ‘Agency’) shall set up and maintain an electronic database for the reporting provided for in Articles 38 and 39, which shall be publicly accessible.
Amendment 550 #
Proposal for a regulation
Article 37 – paragraph 2
Article 37 – paragraph 2
2. The investigator shall immediately report serious adverse events to the sponsor unless the protocol provides, for certain adverse events, that no. The investigator shall record all serious adverse events. The sponsor shall submit copies of these repcorting is required. The investigator shall record all serious adverse events. Where necessary, the investigator shall send a follow-up report to the sponsords to the EU database through the EU portal. The investigator shall send a follow-up report to the sponsor and the sponsor shall submit a detailed follow-up report to the EU database as soon as possible.
Amendment 559 #
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
Amendment 570 #
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 584 #
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Amendment 597 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. All clinical trial information shall be recorded, processed, handled, and stored in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection with easily searchable clinical study reports being publicly available online.