Ref. Ares(2019)6643033 - 28/10/2019
16th meeting of the monitoring sub-group of the Coordination Group on the EU clinical trials
Draft minutes of the meeting
Chair: European Commission
Tuesday 17th of September
, European Commission
- members are invited to give comments to the conclusions document as discussed during the
1. Adoption of the agenda
The agenda was adopted.
2. Sprint 10 reporting
Everis presented the results of the KPI for the sprint 10 (and the complete release 10) on the basis of
a powerpoint presentation (see annex). The results of sprint 10 were discussed on the basis of slide
5. As for the release results (slide 11-12-13), some detail was given on the individual results for the
whole release (sprint 7 8 9 10) :
items were finalised and bugs were created, resulting in a net result of
new bugs were identified. However, analysis is still ongoing to pinpoint the
origin and root cause
Regression test results were discussed in more detail. Remedial actions have been already put in
place, but some additional actions will only be taken in sprint 13 still almost 2 months away. The
importance of these tests was stressed they are indicative of the quality of development as a
whole. The evolution over time was clarified this was not clear in the slidedeck.
Additional questions on the whole slidedeck can be transferred to Everis (
3. Conclusions from the monitoring period discussion
A preparatory draft paper was circulated before the meeting as a basis for a discussion on joint
conclusions from the Monitoring Sub-group. A reading of this document was performed.
The group agreed on the conclusions chapter. The quality KPIs are crucial parameters for the project
and should be improved. A better graphic representation of the results is needed in order to not
confuse the reader with the abundance of data.
In the conclusions, a very basic assumption for the audit date is made based on the net items result
of release 10. It was emphasised that this is a very basic estimation that does not take into account
the complexity of the project. This will be clarified in the text, and a more substantiated calculation
will be delivered by EMA end of September.
With regards to the decision tree, there is a consensus that option 2 would be the most appropriate
It is clear that there is then a need to
prolong the monitoring period. Concrete steps were discussed:
Increase focus on the functionalities on the basis of the identified business blockers and
clusters instead of purely focussing on individual items. It was stressed that this should be
seen in a holistic way. In practice, an end-to-end exercise with sponsors and member states
should bring more clarity on the exact status of CTIS, getting a view on which bugs are
blocking the functionalities. It is expected that such exercise would lower the workload to do
before the audit.
A higher quality of work needs to come from Everis. Both on the issue of bug generation
It was explained that the contract with Everis currently is based on the KPI, and is not very
different from the fixed price part. There is a willingness to change the contract in order to
incentivise Everis towards a better performanc
There was no consensus on the introduction of a lead PO. It was pointed out that a fast decision
process is already in place. However, there is still room for improvement. The need for clear
communication and fast decision making was stressed. The need for a lead PO will be further
assessed in the upcoming sprint on the basis of concrete interactions.
All members of the subgroup are invited to comment on the draft document by Thursday 19/09 EOB.
A new consolidated version will be circulated at the latest on 23/09 as a preparation for the
Coordination Group telco on 25/09.