EudraCT & EU-CTR Question and Answer table

1 Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the european union Address for visits and deliveries Refer to Send us a Question Go to Telephone +31 (0)88 781 6000 european Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EudraCT & EU-CTR Question and Answer table Frequently Asked Questions & Answers (FAQs) (July 2020) Note: Additional information on the EudraCT functionalities (user interface, navigation) is available in the user manual on the EudraCT public website: Additional information on the legal requirements for clinical trials is available in EudraLex Volume 10 Additional information on paediatric clinical trials is available on the EC website More information on the latest developments for clinical trials is available on the EC website Item no. Question Answer GENERAL INFORMATION 1.

2 How long is an unused EudraCT number valid for? A EudraCT number is a unique identifier of the trial and once issued, it never expires. It identifies a specific trial. 2. How many languages does EudraCT support? Although EudraCT supports entry of clinical trial data in any EU language, it is advisable that sponsors provide the information, such as for the title of the trial, also in English. 3. EudraCT application displayed a technical error, what should I do? Contact the EMA Service Desk ( EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 2/3 Item no. Question Answer er/portals), using your user credentials for a system hosted by EMA. Non-registered users can refer to this link and click Create an EMA account , before raising a ticket using the service desk portal.

3 4. Is a retrospective trial registration possible in EudraCT ? For any enquiry on the retrospective registration of a clinical trial, a sponsor needs to liaise directly with the National Competent Authority of the Member State where the trial is authorised. Refer to the following link: 5. Where can I obtain the XML schema to prepare a clinical trial application? The EudraCT clinical Trial application form schema (.xsd) is available in the Technical Information section of the supporting documentation pages of the EudraCT website: 6. Are trials using medical devices required to be included in the EudraCT database? Directive 2001/20/EC does not apply to medical devices, active implantable medical devices, and in vitro diagnostic medical devices as defined in Community legislation.

4 You are recommended to follow procedures on devices in place in the country where the clinical trial is conducted/will be conducted. Contact the National Competent Authority of the country(ies) concerned for further details: 7. I am a sponsor. How do I register a trial in EudraCT ? Updated All steps are described here: Directive 2001/20/EC establishes specific provisions regarding the conduct of interventional clinical trials, including multi-centre trials on human subjects involving EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 3/4 Item no. Question Answer medicinal products. Sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and the Competent Authority of the Member State concerned has not informed sponsor of any grounds for non-acceptance.

5 Before commencing a clinical trial, sponsor shall be required to submit a valid request for authorisation to the Competent Authority of the Member State in which the sponsor plans to conduct the study. The response from the Competent Authority, whether the request for authorisation is positive or negative, could take up to 60 days. Before submitting an application to the National Competent Authority, the applicant should obtain a unique EudraCT number from the EudraCT Community clinical Trial System by the procedure described in the Help file: # This number identifies the protocol for a trial, whether conducted at a single site or at multiple sites in one or more Member States. To obtain the EudraCT number automatically from the database the applicant will need to provide a few items of information. The applicant should submit a signed cover letter with the application.

6 Its subject line should contain the EudraCT number and the invariable sponsor protocol number (if EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 4/5 Item no. Question Answer available) with the title of the trial. Please note that the concept of sponsor and Legal Representative of the sponsor are both in the CT1 guidance attached and in the Directive as well. From a practical point of view you need to follow the instructions below: sponsor can create, save xml/pdf files of clinical Trial Applications locally only after obtaining a EudraCT Number from the system; sponsor has to load locally saved clinical Trial Applications to complete, validate, compare or use to prepare a package for submission to a National Competent Authority; sponsor has to click on create EudraCT number and fill in the information; The system will automatically issue an EudraCT number sending an email confirmation to the applicant (please check your spam folder/filer settings).

7 The automated message cannot be re-sent by the system; The applicant can now create, save and submit the CTA as per the above mentioned instructions. Note: Sponsor is unable to save xml files to the EudraCT system. Only National Competent Authorities are able to do this upon submission of the xml file. 8. I am a sponsor. Who is responsible to update the information for the end of trial? Moreover, for any It is responsibility of the National Competent Authorities to update the information, provided by the sponsor in the EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 5/6 Item no. Question Answer substantial amendment? EudraCT system for end of trial, substantial amendment and approval of the clinical trial application form. Off-note: If the trial is multi-county, the sponsor has to provide this information to each Member State and they will have to enter the same information in EudraCT for each country.

8 9. I am a sponsor. If the sponsor s information changes during the course of the trial or if there is a new sponsor taking over the management/responsibilities of the trial, how does it work the change in sponsorship? The EMA does not have any role in this matter. This has to be managed internally. There is no specific form to fill out. In order to change the sponsorship for a trial(s) there should be an internal agreement between the former sponsor and the new sponsor. This applies to both protocol information and results. Off-note: For protocol information: the sponsor should provide a substantial amendment form along with the amended XML CTA file to the NCA; For results information: the new sponsor can change the sponsors details directly in the results data model. 10. I am an external user. Where can I find the technical documentation ( release note) in EudraCT ?

9 Technical documentation is visible under the Technical documentation page (link below): 11. I am a sponsor. How do I log into EudraCT ? If you are a sponsor and you are preparing the clinical trial application form, you do not need the access to EudraCT , EudraCT & EU-CTR Question and Answer table EMA/370102/2016 Page 6/7 Item no. Question Answer unless you are a third country data provider preparing the clinical trial application form for a trial conducted in third country and which is part of a PIP (Paediatric Investigation Plan). Steps are described here: You can prepare the clinical trial application form on the screen. Follow instructions on the user manual # If you are preparing the clinical trial application form for a third country trial, follow instructions in Q83.

10 Off-note: the public view of EudraCT is the EU CTR ( european clinical Trials Register). Access to EudraCT secure is allowed only to the National Competent Authorities, EMA staff and european Commission according to Art. 11 of the Directive 2001/20/EC (link below): :02001L0020-20090807 12. I forgot my username/password/security questions in order to login into EudraCT , or my username/password/security questions don t seem to work when I try to login, who shall I contact? Sponsors need to send an email to in order to have their credentials re-set or their accounts re-activated. 13. I am a sponsor and I have requested the EudraCT number to start preparing the clinical trial application form. However, I have not received the automated You can contact your IT department to confirm that emails received are not being filtered, blocked or moved.