15th meeting of the monitoring sub-group of the Coordination Group on the EU clinical trials
Draft minutes of the meeting
Chair: European Commission
Wednesday 28 August 2019
, European Commission
- intermediate reporting to be continued for sprint 10
- Everis to provide additional data on the regression tests
- members of the monitoring sub-group to provide proposed conclusions of the monitoring period to
1. Adoption of the agenda
The agenda was adopted.
2. Sprint 9 reporting
Everis presented the results of the KPI for the sprint 9 on the basis of a powerpoint presentation (see
(due to new major bugs)
. This issue is further investigated Everis will provide
additional information, more specifically on the regression tests in the FAT environment and
possible cause of the performance issue (action point).
The intermediate reporting after FAT and SAT will be maintained (action point).
Everis has taken corrective actions, but some of them might have an impact only after the delivery of
the current release.
some remedial actions wil not be visible in the results from release 10. However, intermediate
results of the first sprint from relase 11 (sprint 11) will be known at the end of September.
Everis has also put in place an internal audit in order to identify new improvement actions the
results of this audit will be available for the next monitoring sub-group meeting.
With regards to sprint 10, a number of items
were excluded from the scope, implying that they
will not be further developped in the current release. On the other hand, some items that were
supposed to be in sprint 10 were already developped and covered in the business validation for
3. Internal discussion on results and thresholds
The results of the KPI were compared with the tresholds that were defined by the Monitoring sub-
group see the table below.
3. Readiness for
Release 1 scope
% actual/ planned % of items
% of readiness
items in scope
intermediate monitoring will be maintained in order to get quick feedback on the (intermediate)
result for sprint 10.
4. Preparation of the conclusions from the monitoring period
As the monitoring period comes to an end mid-September, conclusions need to be drafted on the
next steps for the CTIS period, and this on the basis of the results of the fixed price part and the
release done under the new delivery model.
All members of the monitoring sub-group are invited to share their (preliminary) conclusions in order
to formulate a document summarizing the outcome of the monitoring period to share with the
Coordination Group (25/09/2019) and subsequently with the EMA Management Board (4/10/2019).
Feedback can be sent to the Commission, who will draft a draft proposal to be tabled at the next
monitoring sub-group on the 17th of September.
5. Upcoming meetings
Monitoring sub-group (sprint 10 results)
CTR Coordination group meeting (results of release 1)
EMA Management Board