[Evelien]

When we run into problem with submission and approval process for our IMP to an authority, while that IMP was linked to the endpoints of a primary analysis (from which the outcome determines our protocol completion but also the set up of all trials using that compound). Due to the criticality of the shipment, a lot of pressure was put on different levels leading to a lot of frustration, a lot of miscommunication / minimal communication from some parties what in it’s own term worsened the situation as it was no clear how to proceed and how to get out of the web and get things moving. In the end the local people were involved at several levels and they received the necessary information using their internal networks. their support really weighted in the resolution of the problem and it has been acknowledged that we should ask for their support more and keep them more up to date so issues do not escalate to that level anymore. Although the intention to involve local levels better and more open now, it remains difficult to determine when to escalate as all parties do not want to receive more than needed information (due to the high internal workload at all parties).