June 2021: EMA Update

EudraCT and EU CTR application maintenance weekend 18 to 20 June 2021

The European Medicines Agency (EMA) will be performing essential maintenance to IT infrastructure components during the weekend of 18 to 20 June 2021. As a result, EudraCT and EU CTR websites will be unavailable to users between 18:30 hrs. (Central European Time, CET) on Friday, 18th June and 23:59 hrs. (CET) on Sunday, 20th June 2021.

April 2021: What’s New on EudraCT

The below update was posted on EudraCT What’s New section, on April 16, 2021:

A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results.

Changes:

  • Q. 30: Provides more information regarding a third country trial
  • Q. 55: Provides an additional reference for contents of results information to be included in a summary attachment
  • Q. 67: Question updated to add ‘user or delegated preparer
  • Q. 70: Provides information for a sponsor to directly upload a PDF document; previously, the NCA was to be contacted who would then upload the document
  • Q. 78: Statement added ‘A link to the old version will remain published in the EU CTR to keep track of the changes and for transparency reason.
  • Q. 81: Addition of statement about errors and warning
  • Minor grammatical and typographical corrections

February 2021: Clinical Trials Information System (CTIS) Update

Clinical Trials Information System (CTIS): training programme

European Medical Agency (EMA) made available a page, Clinical Trials Information System (CTIS): training programme, for a variety of online training modules, on February 09, 2021.

Each module contains a summary of the topics it covers and learning materials. These consist of e-Learning courses, quick guides, infographics, videos, frequently asked questions (FAQs) and instructor guides. The learning materials are accessible via links unless they are not yet available.

EMA will add new modules and materials throughout 2021.

December 2020: EMA Update

IT systems temporarily unavailable from 31 December 2020 to 1 January 2021

Several European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable between 08:00 on Thursday 31 December 2020 and 18:00 on Friday 1 January 2021 (Central European Time, CET).

This is due to essential maintenance related to the end of the transition period for Brexit: the United Kingdom’s withdrawal from the European Union. EudraCT, EMA Account Management, Clinical data website are among the systems to get affected due to this maintenance next week.

Click here to go to the original news.

December 2020: UK Regulatory Update

An FAQs document was published by MHRA on 21 December 2020. The guidance document referred to in the FAQs is the guidance document published on September 01, 2020 (LINK).

Section C, questions 3, 4, 5, 7, 8 and 9 deal with disclosure related aspect. Below are the summarized points based on the questions and answers:

  1. For the UK clinical trials (CTs) approved and entered in EudraCT prior to January 01, 2021, the results posting can still be completed in EudraCT. This will meet the UK publication requirement.
  2. For CTs approved after January 01, 2021, results can be posted on a public database, where the study is registered.
  3. Once the results are made public, an email confirmation must be sent to MHRA about the same.
  4. If a clinical trial is not on a public register (e.g. Phase 1 healthy volunteer), summary results should be submitted to the MHRA.
  5. The Health Research Authority (HRA) at [email protected] will need to be contacted, in case deferral is required.
  6. If a Phase 1 healthy volunteer study is approved before December 31, 2020, and entered on the EU Clinical Trials Register (but not visible to the public), then either a copy of the EU Clinical Trials Register upload or a copy of the CSR synopsis has to be submitted to MHRA

December 2020: CTIS Update

The second issue of the Clinical Trials Information System (CTIS) Highlights is published on December 09, 2020.

This issue explains the CTIS benefits, CTIS features including user administrators and roles,  member states and sponsor interaction, CTIS training and audit.

Additionally, it also provides the future developments for CTIS as below:

Go-Live is planned for December 2021 and CTIS will be further
developed to include:

  • The safety reporting module which will be fully combined with
    the CTIS components and other safety reporting features will
    be improved;
  • The sponsor workspace with enhanced functionalities;
  • Enhanced functionalities available for oversight, cooperation,
    supervision and visibility within and among Member States;
  • Improved users’ navigation and experience.

After Go-Live more functionalities will be released such as:

  • The public register will be enhanced;
  • Reporting, cooperation, interoperability functionalities will be
    improved;
  • User experience features will be further strengthened.

December 2020: What’s New on EudraCT

The below update is posted on EudraCT What’s New section, on December 07, 2020. The information is not new as such, and all the points that have been published so far regarding the Brexit and the action required therefore, are reported in a summary format. The sponsor is required to make changes to the Clinical Trial Application (CTA) as mentioned below:

From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:

  1. Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
  2. Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
  3. Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.

Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application (click on “EudraCT number, CTA & Login for posting results”, then “load -> EEA CTA”, add the CTA XML file, perform the changes and save the CTA file locally). The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.
Please note that it is already possible for sponsors to modify the XML file of their CTAs with the following:

  • Update section B.1 with a sponsor based in EU/EEA
  • Update section B.2 with a EU/EEA legal representative for third country sponsors having a legal representative based in UK
  • Update section D.9 with a Qualified Person based in EU/EEA

In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:

  • Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
  • Update section D.9.2.4.4 specifying “Northern Ireland” in the country field

When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.

November 2020: What’s New on EudraCT

EudraCT posted the following update on November 24, 2020:

The Frequently Asked Questions document has been completely revised. Sponsors are encouraged to refer to it for questions on EudraCT/EU CTR. Comments and suggestions on the document are also welcome, to be sent via the Service Desk.

The Service Level Agreement for the addition of a new active substance in EudraCT has changed. Now it could take 5-10 days to have a substance added in section D. of the Clinical Trial Application form. The process is described in the Frequently Asked Questions.

October 2020: What’s New on EudraCT

EudraCT What’s New section posted the below update on October 19, 2020:

In order to receive assistance with your EMA account, enable it again or recover a username / password, please refer to EMA Account Management.

October 2020: What’s New on EudraCT

The release notes for EudraCT version number 10.5.0.0 are now available in the Technical documentation section.

Section 2.1 of this document refers to the process a sponsor could follow to post results for prematurely ended trials.