The minutes of the 102nd meeting of the EMA Management Board which was held in London on 12-13 December 2018, is published.
Clinical Trials Information System required by the Clinical Trial Regulation
a) Update on the CTIS Project: [EMA/MB/744007/2018; EMA/743977/2018] The board noted the Update on the status of the development of the Clinical Trials Information System (CTIS). There is a significant delay in the delivery of the system for the User Acceptance Testing (UAT7) of Release 0.7 (auditable release) after the ongoing Site Acceptance Testing (SAT) identified necessary bug-fixings and additional findings were identified in a Preliminary User Acceptance Testing (pre-UAT7) on 5-13 November, in which both Member State and Sponsor UAT Champions participated. Member States UAT champions concluded that Release 0.7 of CTIS is not yet ready for a full UAT. Release 0.9 (safety reporting) is being developed under another contract and is making progress as planned. At the October meeting of the Management Board, the EU CTR Coordination Group was mandated to work on the implementation of the main recommendations from the external review reports, to supervise UAT7 and prepare the action plan with a clear time frame for the December meeting. In view of delays and slow rate of bug-fixing, EMA discussed with the Coordination Group in November and December possible options within the current landscape, which were then also submitted to the Topic Coordinators so that recommendations on the way forward could be prepared for the board.
b) Update from the EU CTR Coordination group: The board heard and discussed the update from the EU CTR Coordination group presented by Xavier De Cuyper and endorsed the recommendation of the EU CTR Coordination Group on options to ensure CTIS delivery. At the meeting of the Coordination Group in Vienna on 20 November the progress in the implementation of the new governance and the successful performance of pre-UAT7 with the involvement of Member States champions and experts was acknowledged. However, the high number of bugs and issues reported, as well as the overall delays incurred, prompted the Coordination Group to ask EMA to prepare options to mitigate further delays and ensure delivery of CTIS. The presented options were compared on the basis of criteria referring to time to deliver, risk level, estimation of cost and level of uncertainty. On this basis at the meeting of 6 December 2018 the EU CTR Coordination Group identified the option to revise the delivery approach requiring the Contractor currently developing CTIS to modify its delivery team accordingly, as the most likely to deliver with minimal delay a system which is meant to increase innovation and competitiveness in the EU for the benefit of patients. Key success factors would include: requiring adhesion to strict timelines; adjusting the working methodology to a transparent iterative process and strengthened participation by end-users; limiting change requests in the interest of go-live of the system as soon as possible, but retaining the possibility to extend functionalities in the future; close monitoring of progress against milestones and timelines by a small subgroup of the Coordination Group and careful implementation of the project assurance recommendations, particularly in strengthening project management. The Management Board would decide after six months of activity whether the new approach is deemed appropriate to enable the Contractor to deliver release and system ready for UAT7. The EU CTR Coordination Group, in view of the great complexity of the project and the importance and urgency of the system for the EU, invited the board to endorse the option proposed, mandating the Coordination Group to implement this decision focussing on the delivery of a functional (basic) EUPD and reporting on progress on the basis of key success factors at every meeting of the board. EMA, with the support of the European Commission would be asked to prepare a fall-back solution in case the expected results are not being delivered after six months of activity.
In the discussion that followed there was a request for further assurance on involvement of experts and on improved project management. The representative of the European Commission DG SANTE stated that the Commission could back the option proposed by the EU CTR Coordination Group, as the one presenting fewer risks and timelines allowing implementation of the legislation on Clinical Trials by December 2020. The other conditions proposed by the Coordination Group are very important, in
particular the proposal to review the decision in six months. Other members stressed that the decision in front of the board was only a first step, and that the new governance in place will allow closer collaboration, while the implementation of the recommendations of the independent project assurance reports might bring further benefit. The proposed solution is pragmatic and workable, and will be accompanied by mitigation measures and a fall-back plan. The Executive Director informed that he had considered the option of terminating the current contract for the development of CTIS and exploring other manners of delivering the system, but accepted the analysis and recommendation of the Coordination Group to revise the delivery approach, while a possible fall-back scenario is being
prepared in case the expected results are not being delivered after six months. He reassured the board that EMA will continue to build the system beyond going live, and that the new sprint methodology together with proper capacity and capability resourcing at EMA based on the profiles suggested by the independent project assurance reports will bring improvements. The board endorsed the recommendations by the Coordination Group, including the request for full commitment by the Member States and EMA, and a review in six months’ time.
The full report can be found on the following link: https://www.ema.europa.eu/en/documents/minutes/minutes-102nd-meeting-management-board_en.pdf