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('Ct-3')(2011/C 172/01 11.6.2011 EN Official Journal of the European Union C 172/1 II (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01) 1. INTRODUCTION Area (‘EEA’) ( 2 ), sponsors and investigators, as well as persons to whom tasks and functions related to safety 1.1. Legal basis reporting have been delegated, should consider this guidance when applying Directive 2001/20/EC. 1. This detailed guidance is based on Article 18 of 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 1.2. Scope Member States relating to the implementation of good clinical practice in the conduct of clinical trials on 4. This detailed guidance addresses the collection, verification medicinal products for human use ( 1) (hereinafter and reporting of adverse events and adverse reactions ‘Directive 2001/20/EC’), which provides that: which occur in a clinical trial falling within the scope of Directive 2001/20/EC, i.e. a clinical trial as defined therein and performed in at least one EU Member State. ‘The Commission, in consultation with the Agency, Member States and interested parties, shall draw up and 5. For more details on the scope of Directive 2001/20/EC publish detailed guidance on the collection, verification reference is made to section 1.2 of the Detailed guidance and presentation of adverse event/reaction reports, on the request to the competent authorities for authori­ together with decoding procedures for unexpected sation of a clinical trial on a medicinal product for human serious adverse reactions.’ use, the notification of substantial amendments and the declaration of the end of the trial ( 3) (hereinafter ‘detailed guidance CT-1’). 2. According to Article 3(1) of Directive 2001/20/EC, all national provisions on the protection of clinical trial 1.3. Definitions subjects have to be consistent with the procedures and 6. The definitions contained in Directive 2001/20/EC, its time-scales set out in Directive 2001/20/EC, including implementing Commission acts and relevant Commission procedures and time-scales for the collection, verification guidance documents in their current versions also apply in and presentation of adverse reaction reports arising from respect of this detailed guidance. clinical trials on medicinal products for human use. This document provides guidance on these aspects. 7. Regarding the terms ‘adverse event’, ‘adverse reaction’, ‘suspected’, ‘unexpected’, and ‘serious’, reference is made to the respective sections of this detailed guidance. 3. National competent authorities and Ethics Committees of the Member States of the European Union (‘EU’) and of 2 the Contracting States of the European Economic ( ) For the purposes of this document, references to the EU, EU Member States or Member States should be understood to include the EEA or EEA Contracting States, unless indicated otherwise. ( 1 ) OJ L 121, 1.5.2001, p. 34. ( 3 ) OJ C 82, 30.3.2010, p. 1. C 172/2 EN Official Journal of the European Union 11.6.2011 8. For the purposes of this detailed guidance, ‘Member State — an adverse reaction to an IMP or non-IMP occurring in concerned’ means the Member State in which the clinical a clinical trial is only to be reported or followed up in trial has been authorised by the national competent accordance with Directive 2001/20/EC. In applying authority and received a favourable opinion of the that Directive, this detailed guidance should be Ethics Committee. complied with. 1.4. Interface with other guidance documents 13. Thus, the responsibilities of sponsors and investigators as regards safety reporting are determined only by Directive 9. This detailed guidance is to be read in conjunction with, 2001/20/EC. in particular: 3. RESPONSIBILITIES OF THE INVESTIGATOR AND — the detailed guidance CT-1, and SPONSOR AS REGARDS MONITORING AND SAFETY REPORTING — the Note for guidance on clinical safety data 14. The investigator’s responsibilities entail: management: Definition and standards for expedited reporting ( 4 ) (hereinafter ‘note for guidance ICH E2A’). — reporting of serious adverse events to the sponsor (see section 4), 10. Where appropriate, this detailed guidance reproduces the content of the above-mentioned guidance documents in order to facilitate application of the rules on safety reporting. — reporting of certain non-serious adverse events and/or laboratory abnormalities to the sponsor (see section 5). 2. INTERFACE WITH PHARMACOVIGILANCE RULES 11. The pharmacovigilance rules laid down in Directive 15. The sponsor’s responsibilities entail: 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 5) (here­ inafter ‘Directive 2001/83/EC’) and Regulation (EC) No — recording of adverse events (see section 6), 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of — reporting of suspected unexpected serious adverse medicinal products for human and veterinary use and reactions (‘SUSARs’) to the national competent establishing a European Medicines Agency (hereinafter authority (be it directly or through the Eudravigilance 6 ‘Regulation (EC) No 726/2004’) ( ) do not apply to inves­ Clinical Trials Module, see section 7.4) and the Ethics tigational medicinal products (‘IMPs’) and non-investi­ Committee (see section 80), gational medicinal products ( 7) (‘non-IMPs’) ( 8). — informing the investigators (see section 7.10), 12. It follows that: — annual safety reporting to the national competent — safety reporting falls either under Directive 2001/20/EC authority and the Ethics Committee (see section 8). or under the provisions on pharmacovigilance as set out in Directive 2001/83/EC and Regulation (EC) No 726/2004. Adverse reactions may not be reported under both regimes, i.e. Directive 2001/20/EC as 16. The sponsor should continuously weigh anticipated well as Regulation (EC) No 726/2004 and Directive benefits and risks of the clinical trial ( 9), which includes 2001/83/EC, ongoing safety evaluation of IMPs. ( 4 ) CPMP/ICH/377/95 (http://www.ema.europa.eu/pdfs/human/ich/ 037795en.pdf). ( 5 ) OJ L 311, 28.11.2001, p. 67. 17. The sponsor should arrange for systems and written ( 6 ) OJ L 136, 30.4.2004, p. 1. standard operating procedures to ensure compliance ( 7 ) For guidance on these terms, see Guidance on Investigational Medicinal with the necessary quality standards at every stage of Products (IMPs) and ‘non investigational medicinal products’ (NIMPs) case documentation, data collection, validation, evaluation, (http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm). archiving, reporting and following-up. ( 8 ) Article 3(3) of Directive 2001/83/EC, See also Article 107(1), 3rd subparagraph of Directive 2001/83/EC, as amended by Directive 2010/84/EU of 15 December 2010. ( 9 ) Section 2.2. of ICH E6 — Good clinical practice. 11.6.2011 EN Official Journal of the European Union C 172/3 18. Regarding clinical trials with advanced therapy investi­ ‘Any untoward medical occurrence or effect that at any gational medicinal products, specific guidance is dose results in death, is life-threatening, requires hospitali­ contained in the detailed guidelines on good clinical sation or prolongation of existing hospitalisation, results practice specific to advanced therapy medicinal in persistent or significant disability or incapacity, or is a products ( 10 ). congenital anomaly or birth defect’. 19. Delegation of tasks does not remove the ultimate respon­ 25. These characteristics/consequences have to be considered sibility of the sponsor or investigator for the conduct of at the time of the event. For example, regarding a life- the clinical trial in accordance with the applicable legis­ threatening event, this refers to an event in which the lation. subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. 4. REPORTING OF SERIOUS ADVERSE EVENTS BY THE INVESTIGATOR TO THE SPONSOR 26. Some medical events may jeopardise the subject or may 4.1. Legal basis and purpose require an intervention to prevent one of the above char­ acteristics/consequences. Such events (hereinafter referred 20. Article 16(1) of Directive 2001/20/EC reads as follows: to as ‘important medical events’) should also be considered as ‘serious’ in accordance with the definition. ‘The investigator shall report all serious adverse events immediately to the sponsor except for those that the 27. Medical and scientific judgement should be exercised in protocol or investigator’s brochure identifies as not deciding whether an event is ‘serious’ in accordance with requiring immediate reporting. The immediate report these criteria ( 12 ). shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter.’ 4.3. Timelines 28. The investigator has to immediately report to the sponsor 21. The purpose of this obligation is to ensure that the all serious adverse events with the exception of those that sponsor has the necessary information to continuously are identified as not requiring immediate reporting in the assess the benefit-risk balance of the clinical trial, in protocol or the investigator’s brochure (‘IB’) ( 13 ). accordance with Article 3(2)(a) of Directive 2001/20/EC. 4.3.1. Immediate reporting and follow-up report 4.2. ‘Serious adverse event’ 29. Immediate reporting should allow the sponsor to take the 4.2.1. ‘Adverse event’ appropriate measures to address potential new risks in a 22. An ‘adverse event’ is defined in Article 2(m) of Directive clinical trial.
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