EU-X-CT: TF1 Mapping Exercise Logo
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  • The EU Cross-border Clinical Trials Multistakeholder Initiative

    Borders should no longer be barriers
  • Survey regarding legal, regulatory & ethical landscape regarding cross-border access to trials
     
    Welcome and a sincere thank you for your interest in taking part in our cross-border access to clinical trials mapping exercise which is part of the EU-X-CT Initiative. With the following few questions, we are aiming to collect legal, regulatory, and ethical aspects of cross-border access to clinical trials.
     
    The EU-X-CT initiative aims to bring together reliable and accessible information regarding legal, regulatory and ethics as well as practical aspects on conditions and options for cross-border access to clinical trials with medicinal products (drugs) according to Article 2.2 of the EU Clinical Trial* Regulation 536/2014 or respective national law. This is particularly important for patients with life-threatening and/or rare diseases for whom a medicinal product under investigation might be the only therapeutic option.

    In addition to your responses to the questionnaire, we will also collect some personal data to be able to contact you for follow up (if needed). Moreover, we would like to share with you the mapping exercise results, initiative outcomes and invite you to the future EU-X-CT events.
     
    We will only collect and store the data you provide for the EU-X-CT initiative and will not use your contact details for any other purpose.
     
    *‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
    (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
    (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
    (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

  • Personal Data

  • Background Information

  • Dear colleague,
     
    We highly appreciate your support for this initiative by providing detailed answers to the questions below regarding national information on the legal and regulatory framework and options for cross-border participation in clinical trials.
     
    According to your field of expertise, you will be provided with a set of questions. There are two sets of questions, one for knowledgeable persons with Legal and/or regulatory background, and one for knowledgeable persons with ethical background; you select one or both options (i.e. knowledgeable in one or all fields). Each set of questions takes approximately 10-15 min to answer.
     
    Please be informed that in addition to the current mapping exercise regarding legal, regulatory and ethical frameworks, other surveys are conducted to capture the reimbursement and operational situation related to cross-border participation in clinical trials.

  • We are aware of the complexity of the topic and the questionnaires. It is possible that you would not be able to answer all questions. This does not matter. Any information you can share is valuable and it does not have to be fully complete.

  • LEGAL and REGULATORY aspects

  • Is there a legal or regulatory framework which enables cross-border access to clinical trials in the following situations:

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  • In case there is NO legal or regulatory framework for cross-border access to clinical trials, how are such requests dealt with in the following situations:

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  • Is there a legal or regulatory framework which enables cross-border access to clinical trials in the following situations:

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  • In case there is NO legal or regulatory framework for cross-border access to clinical trials, how are such requests dealt with in the following situations:

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  • ETHICS aspects

  • Is there an ethics framework/rule which enables cross-border access to clinical trials in the following situations:

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  • In case there is no such ethics framework/rule, is participation in a clinical trial possible on a case-by-case basis in the following situations:

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  • Is there a legal or regulatory framework which enables cross-border access to clinical trials in the following situations:

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  • In case there is NO legal or regulatory framework for cross-border access to clinical trials, how are such requests dealt with in the following situations:

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  • Any comments?

  • Terms of Use and Data Protection Policy

  • Terms of Use and Data Protection Policies

    We respect your trust, and the protection of the personal data is important to us. Therefore, we act in accordance with the European General Data Protection Regulation (GDPR). By filling out this form you acknowledge that your personal data will be provided to EU-X-CT Core Management Team, EU-X-CT Members, and Task Force members carrying out the mapping exercise to identify and collect available contacts who can provide information on enabling cross-border access to clinical trials. The contact information may be shared with EFPIA Staff, but will not be given to any other third party and, will be handled by EFGCP within the framework of the EU-X-CT Project according to the EFGCP Privacy Policy. If you have additional questions on data privacy policy or you might want to have your personal data deleted or amended, you can contact the EFGCP Data Protection Officer of the EFGCP in writing at secretariat@efgcp.eu.

    In the scope of this survey, EFGCP will process your data as data controller for the purposes that were presented to you. The legal basis for processing your personal data is consent (Article 6(1)(a) of Regulation (EU) 2016/679). Your data will be processed according to the EFGCP Privacy Policy.

    By filling out this survey, you agree for your personal data to be stored by EFGCP, and made accessible to the EU-X-CT Members. You have the right to ask your data to be amended or deleted by contacting secretariat@efgcp.eu.


    EFGCP will provide its services in a professional and compliant manner using best efforts to protect personal data. When sharing your personal data for the purpose of the EU-X-CT Project to the participating stakeholders, EFGCP will implement appropriate safeguards. Each participating stakeholder is an independent controller and has agreed to carry out the tasks assigned to it in this Project with care and diligence applying their own safeguards for the received personal data. The parties hereto acknowledge and agree that nothing in this statement contained, and nothing done pursuant hereto by participating stakeholders shall be deemed to constitute a direct or indirect guarantee by EFGCP of any liability. EFGCP cannot be held responsible for any data leaks, IT issues, hacks, misuses, or any harms to you, your organisations or your activities, due to your involvement in the EU-X-CT Project Activities.

     
    Personal Data Gathered:

    • Name, Surname
    • eMail Address
    • Organisation, Role
    • Country
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