11th meeting of the monitoring sub-group of the Coordination
Group on the EU clinical trials Regulation
Tuesday 11th of June 2019
, European Commission
1. Adoption of the agenda
The agenda was adopted.
2. Decision tree for the success of progress on CTIS (EC EMA)
EMA presented the decision tree proposal that was circulated, including some comments from the
s, checked against the
tolerance criteria that the monitoring subgroup have defined. If all KPI are met, the project can
However, when Everis should not meet the KPI tresholds, different scenario could arise, depending
target. The decision tree is
Most difficult will be the problems of predictability and quality as is it not possible on forehand to
define what the course of action will be. It was emphasised that the monitoring of the KPI is an
ongoing process, and that the subgroup will continue to monitor the results of the upcoming sprints.
This message should also be conveyed to the EMA Management Board.
The monitoring subgroup adreed on the decision tree proposal as discussed during the meeting. It
was agreed that the KPI, the tolerance criteria and the decision tree could be presented to the EMA
management board. The KPI will be monitored and further refined (if needed) during summer, and
will than be discussed at the EMA Management Board of October.
Members are invited to send comments to the decision tree to
Coordination Group meeting on Friday 14/06.
3. Results for sprints 5 and 6 (EMA IT4U)
The outcome of sprints 5 and 6 (i.e. fixed price part) were discussed. Some KPI were generated
although the KPI were not designed for this model. The schedule adherence for sprint 5 was not in
line with defined tresholds. However, as a whole, the results for iteration 4 (i.e. sprint 5 + 6 + SAT)
were positive. There were no blockers remaining.
4. CTIS project update (EMA- IT4U)
Everis was invited for this part of the meeting and explained the interim update slides. He stressed
that a critical phase of the project has started today 11th of June. The
on the safety
reporting took some more time than foreseen. A new version of the sandbox will be deployed soon.
It is proposed to start the next meeting of the Monitoring Subgroup with the reporting from Everis, in
order to have sufficient time to monitor the progress.