Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) recently published an updated Version 2.3 of the draft Questions & Answers (Q&As) relating to the Clinical Trials Regulation (EU) No 536/2014 (CTR). The Q&As have been discussed progressively since December 2014 and the final draft (Version 1) was finalized in April 2018. The Q&As enter into force on application of the CTR which depends on the notice of the full functionality of the EU Portal / database (CTIS).

Changes compared to the superseded Version 2.2 are:

Q&As added or revised: 1.7, 5.2, 2.8 What should be understood under conditions (NEW)

  • 1.7 A study might involve the administration of a medicinal product, while the object of the investigation is not the administered medicinal product, but exclusively the physiology of the body. Are these studies 'clinical trials' as defined in the CTR?
    In principle the answer is "No". In studies, which have the only objective to investigate the physiology of the body, the medicinal product is used as a tool with the aim to provoke a well characterized physiological response. These studies are not 'clinical trials' (CTs) as defined in the CTR and the medicinal product administered is not an investigational medicinal product (IMP). Thus, these studies are not regulated at EU-level and it is therefore up to Member States (MS) to decide whether and how they regulate these studies. However, care has to be taken as to whether the object of an investigation is being 'switched', in the course of a study, from the physiology of the body to the pharmacological effect triggered by the medicinal product. In this case, a study may 'turn into' a CT which falls within the scope of the CTR.
  • 5.2 How responsibilities are shared in case of co-sponsorship?
    In case a CT has more than one sponsor, all co-sponsors shall in principle have the responsibilities of the sponsor. This implies that all of them are jointly responsible (e.g. also for the safety issues) and a MS concerned may expect the execution of a sponsor's obligations from any of the co-sponsors. However, the co-sponsors shall jointly determine, in a written contract which sponsor will be responsible for the following tasks:
    - compliance with a sponsor's obligations in the authorization procedure;
    - a contact point for receiving questions from subjects, investigators or any MS concerned regarding the CT and for replying to them;
    - implementing corrective measures imposed by any of the MS concerned.
    Each task mentioned above can be attributed to one single sponsor. Co-sponsors cannot have a joint responsibility for any of the tasks mentioned above. This means that the responsibility for compliance with each of the above tasks will lie with one single sponsor and cannot be shared by several sponsors. This does not preclude that the sponsor can delegate certain tasks to third parties. The co-sponsors may split up all remaining responsibilities by contractual agreement. If they do not do this, the principle of joint responsibility applies. However, the sponsor bearing the overall responsibility for the obligations in the authorization procedure remains responsible to fulfil this role and therefore this sponsor needs to have full access to the documentation. It is assumed that co-sponsors have agreed through a contractual agreement on the exchange of information necessary to allow the responsible sponsor to take informed decision for compliance on behalf of all sponsors during the authorization procedure.
  • 2.8 What should be understood by conditions?
    Q&A 2.8 “How to use conditions” was endorsed by the CTFG (Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency). An authorization of a CT subject to conditions is
    - restricted to conditions which by their nature cannot be fulfilled at the time of that authorization,
    - only possible in case of an application with a positive benefit / risk balance,
    - possible when the conditions are related to an issue already identified in the request for information (RFI) submitted during the assessment. 
    When all MS concerned are in agreement, conditions can be used: 
    - To request additional data not available at the time of the authorization,
    - To indicate aspects that the sponsor need to fulfill after the authorization.

More information can be found in the draft CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 2.3.

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