EMA Clinical Trial Information System Summary Status

Provided by Simon Lee, Dagmar Chase and Martine Dehlinger-Kremer – EUCROF management board

The EMA held a Stakeholders Meeting on 23 July 2020 to provide an update on the progress being made with the development of the Clinical Trial Information System (CTIS). EUCROF was represented at this virtual meeting by Martine Dehlinger-Kremer (EUCROF President), Simon Lee (EUCROF Secretary) and Dagmar Chase (Chair of the Clinical Trial Legislation WG). Given the importance of this IT system to the implementation of the EU Clinical Trial Regulation and the critical stage of its development , we wanted to provide you all with a summary update of its status based on what was learnt at the meeting.

Development  Progress

The EMA switched to a new approach to develop this important project in 2019, which now involves an iterative and more agile project delivery model such that the project develops and delivers functionalities through short-cycled sprints that require planning of the scope, analysis, design, development and delivery. EUCROF continues to contribute to the CTIS development directly through its two Products Owners (POs) who play an integral role in the testing of the system identifying any issues that require resolution prior to the next stage. As a reminder EUCROF’s POs are Lydia Dominguez ( AECIC & SERMES) and Vicki Iassonidou (AFCRO & PRA Health Services) and our continued thanks to both for their continued commitment to representing EUCROF in these development activities.

At the meeting the EMA CTIS team updated stakeholders on the progress made since the last meeting in April 2020. At the time of the meeting the project was midway through Release 14, the fifth release under the new delivery model, addressing items that emerged from Operational Assessments 2 and 3 earlier in the year. Release 15 starting in September will be the last release where audit scope can be implemented before the audit of the CTIS starts in December 2020. The EMA expressed its thanks for everyone’s commitment and involvement during the last 3 months and for working together as ‘One Team’, ensuring adherence to the 2020 plan.

Audit

The audit of the CTIS is a critical milestone for the project and the EMA are still on track to receive the audit in December 2020 in accordance with the plan endorsed by the EMA Management Board last December. The EMA confirmed that following a final prioritisation exercise conducted by the POs in June 2020, the final audit scope list (containing 356 items) was now available and had been endorsed by the Expert Group, Monitoring Sub Group and Coordination Group for the project.  This is excellent news and means that, subject to some final audit readiness confirmation in the coming months, the CTIS is closer to the being audit ready and there is increasing confidence within the EMA team in the ultimate audit outcome. Also the EMA announced that following a formal tender and selection process during April through to June 2020, the specific contract for the audit had been awarded to KPMG AG in Germany and subject to final contract signature the EMA will start liaising with KPMG to initiate audit preparations and planning.

Activities in the coming months will continue at a pace with a further five development sprints between now and the end of the year with Readiness Confirmation (#14) and User Acceptance Testing (#14) both in September 2020.

Training

The EMA are planning to implement a CTIS high level training programme to ensure all future users of the system have the necessary awareness and skills to be able to effectively use it once introduced. The programme will be organised in batches, each encompassing several modules (ca. 20) with the last batch of training materials expected to be delivered by June 2021 in order to be ready for the ‘Go Live’, which is currently anticipated to be from July 2021 onwards, subject to the outcome of the audit and final confirmation of a definitive implementation date by the EMA. Activity levels concerning the programme have increased recently to support the preparedness of the Member States, the Sponsor Users and organisations, and this will continue in the coming months.

On 21 September 2020 there will be a joint EMA/DIA demo webinar, showing some of the training material developed up to that point in time. The EMA said that they would confirm who and how many people could attend shortly.  Also soon there will be a call from the EMA/DIA aiming to identify trainers for the Sponsor training programme, so we will let you know as soon as we hear any news on each of these important points.

The next Stakeholder meeting is scheduled for 23 September and therefore we will provide a further update shortly thereafter.