Clinical Trial Regulation (Regulation (EU) No 536/2014)

Preparing for the Regulation

The HPRA is working with the European Commission’s Expert Group on Clinical Trials, the European Medicines Agency, the Heads of Medicines Agencies Clinical Trials Facilitation and Co-Ordination Group (CTFG), the Department of Health, Ethics Committees and the Irish Pharmaceutical Healthcare Association to prepare for the implementation of the Clinical Trial Regulation (CTR).

The HPRA is also working closely with the newly established National Office for Research Ethics Committees (NREC) on a harmonised, national approach in advance of the introduction of the Regulation and the accompanying Clinical Trial Information System (CTIS).

In addition, the HPRA contributes to the development of International Council for Harmonisation (ICH) guidelines through the Expert Group on Clinical Trials and CTFG groups.

Further information on the CTR is available on the following websites:

The set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable, is available here.

Key Features of the New Regulation

Once implemented, the key features of the new Regulation will include:

  • Identical rules for conducting clinical trials throughout the EU;

  • Increase in the efficiency in approval process for clinical trials;

  • Single submission & approval of multinational clinical trial applications through an EU ‘Clinical Trial portal and database’;

  • A harmonised procedure for assessment by member states, divided in two parts;

  • Strictly defined deadlines for assessment;

  • Involvement of the ethics committees in the assessment procedure.

Clinical Trial Information System (CTIS)

The introduction of the CTR will also see the introduction of the new Clinical Trial Information System (CTIS) which will act as a single entry point for submitting clinical trial information in the EU and will support the daily business processes of Member States and sponsors throughout the life cycle of a trial. Additionally, the CTIS will also assist in making clinical trial information in Europe more accessible and transparent.

Training

The EMA has setup a dedicated CTIS training programme page, which will be updated throughout 2021 so stakeholders are encouraged to check the EMA page regularly for updates.  Training materials for clinical trial sponsors are available on topics such as an introduction to CTIS, Common Functionalities for all registered users, Authority Workspace and Sponsor Workspace.

To further support stakeholders ahead of the introduction of the CTR, and the launch of CTIS, the following training has also been organised by the EMA.

Dedicated training webinars detailing essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors

  • SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 (22 February 2021)

    The first training session will provide an overview of CTIS, user access management (including how to register users), sponsor user management and sponsor roles and permissions in CTIS.

  • SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 (4 March 2021)

    The second training session will cover submitting an initial trial application in CTIS, updating an initial trial application and making substantial modifications along with adding a concerned Member State, making non-substantial modifications and submitting trial results.

It is recommended that participants attend both training dates and a video of the webinar will be published by the EMA after the event.

EMA CTIS Master Trainers’ Training Programme for sponsors

To support the launch of the CTIS the EMA have prepared a CTIS Master Trainers’ Programme which will start in the second quarter of 2021.

The Programme is primarily intended, and due to its extent is suitable, for commercial sponsors from the Pharmaceutical Industry and Contract Research Organisations (CROs) that are likely to submit several clinical trial applications, and that will have many users with different CTIS user profiles within the organisation.

The CTIS Master Trainers Programme consists of 3 parts:

  • Part I: 3 half days training on Essentials for CTIS users.

  • Part II: 4 half days training on the clinical trial application process and the specific CTIS user roles available for sponsors.

  • Train the Trainers: 1 to 2 half days on training design, training delivery and facilitation.

During the first applications period, a maximum of one person per organisation will be eligible to apply. After this date, any remaining slots will be open and eligible organisations can opt to send in more applications. The applications period will close once the programme is full.

  • Deadline for the 1st applications’ period: 16 February 2021

  • Selection announced: 8 March 2021

  • Opening of the 2nd applications’ period: 8 March 2021

For any questions related the fees and registration to the CTIS Sponsor Master Trainers Programme, please contact emaevents@diaglobal.org.

Further information regarding upcoming EMA events and CTIS training can be located on the EMA News and Events and CTIS highlights pages. An EMA organised CTIS webinar on the ‘dynamic demo of sponsor workspace’ was also held in September 2020 and can be located here.