November 2019: EU Clinical Trial Regulation Update

On Nov 7, the EC published an updated Draft Questions and Answers Document (Version 2.2) (Eudralex Volume 10 – Clinical trials guidelines – Set of documents applicable to clinical trials under Regulation EU No 536/2014)

Q&As that were added or revised include, 1.6, 2.2, 2.7 (NEW), 2.8 (NEW), 3.3 (NEW), 6.2:

  • THE SCOPE OF CLINICAL TRIALS REGULATION IN THE EU — 1.6 Is the definition of ‘medicinal product’ relevant for the scope of the Clinical Trials Regulation?
  • APPLICATIONS LIMITED TO PART I  — 2.8 Will the assessment report on part I and II be made public at the time of decision?
  • SUBSTANTIAL MODIFICATIONS — 3.3 What are the sponsor’s responsibilities regarding changes to a clinical trial which are not substantial modifications (SM), but are relevant for the supervision of the trial (Art. 81.9)?
  • SUBMISSION OF RESULTS OF CLINICAL TRIALS — 6.2: Which endpoints need to be summarized in the lay summary of results of a clinical trial?

October 2019: EMA Update

In October 2019, EMA’s Management Board endorsed the six-monthly monitoring report on the development of the CTIS, which assesses the performance of the IT supplier against agreed key performance indicators. The Board agreed that actions proposed in the report should be further developed, for example improving the quality of the work delivered by the supplier and selecting the critical items needed for audit, as well as extending the monitoring period for at least three releases.

The product owners validated the first release developed in the agile, iterative delivery in September 2019, confirming that all 79 items had been delivered.

The release enhanced CTIS functionalities for the submission of clinical trials and the assessment process, user management and included other general improvements.

The product owners will begin to carry out an operational assessment of the system to identify critical business blockers, in order to enable EMA’s Management Board to consider the timing of the audit of the system.

August 2019: What’s New on EudraCT

New updates on the EudraCT website:

August 2019: What’s New on EudraCT

A new template for requesting assignment for results is now available, and can be found here. The template letter for requesting assignment to trials has been slightly modified to allow the automation process to approve/reject the letters.

July 2019: What’s New on EudraCT

Joint Letter by the European Commission, EMA and HMA

A joint letter by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) is published on 03 July 2019.

Relevant protocol and results related information regarding clinical trials that are authorised in the EU needs to be kept in the EU Clinical Trials Database (EudraCT) and publicly available through the EU Clinical Trials Register. In order to improve compliance on the posting of results, the primary aim of this communication is to remind all sponsors about their obligation for the reporting of clinical trial summaries in the EU Clinical Trials Database.

The joint letter is available here.

June 2019: EudraCT Regulatory Update

Version 2 (June 2019) – Questions and Answers on Clinical Trials-Regulation (EU) 536/2014

A draft for the Version 2 of CLINICAL TRIALS REGULATION (EU) NO 536/2014 – QUESTIONS & ANSWERS has been submitted for the discussion.

The draft version is available here.

June 2019: EudraCT Regulatory Update

List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01: Version 2.0

Version 2.0 of the list of fields to be made public from EudraCT for paediatric clinical trials is published. Version 1.0 of the document which was published in February 2009 has been revised to harmonize the title of the fields with the “Technical Guidance On The Format Of The Data Fields Of Result-Related Information On Clinical Trials Submitted In Accordance With Article 57(2) Of Regulation (Ec) No 726/2004 And Article 41(2) Of Regulation (Ec) No 1901/2006”.

According to the recent version, additional data fields related to the Age Range of trial subjects will be made publicly available in the European Clinical Trials Register (EU CTR).

The version 2.0 of the document is available here.

June 2019: EudraCT Regulatory Update

List of fields contained in the “EudraCT” clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02: Version 2.0

Version 2.0 of the list of fields in the EudraCT clinical trials database to be made public is published. Version 1.0 of the document which was published in February 2009 has been revised to harmonize the title of the fields with the “Technical Guidance On The Format Of The Data Fields Of Result-Related Information On Clinical Trials Submitted In Accordance With Article 57(2) Of Regulation (Ec) No 726/2004 And Article 41(2) Of Regulation (Ec) No 1901/2006”.

According to the recent version, additional data fields related to the Age Range of trial subjects will be made publicly available in the European Clinical Trials Register (EU CTR).

The version 2.0 of the document is available here.

March 2019: What’s New on EudraCT

Updated FAQs: EudraCT has updated the FAQs available on its website on March 18, 2019. The newer version (V1.3) is available on the site https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAQ_for%20publication.pdf

The newer version has some newly added content as well as some amended content. The new or amended content is available along with the applicable tag.

February 2019: What’s New on EudraCT

From 15 February 2019 Sponsors/MAH/Third country data providers who wish to assign Clinical Trials to other parties are invited to use the CT result request PDF form. The PDF form will replace the letter format, and its use will be mandated from 1 March 2019. There will be a transition period from 15 to 28 February during which the “letter format” will still be accepted. While the process remains the same the introduction of the form is expected to improve user experience and the processing of requests.

The Clinical Trial assignment request PDF form is available and users can refer to the Guidance for completing the PDF form when filling in the form.