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.