Regulation & Governance
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Hi,
I was hoping to get some advice on working with collaborating sites in the EU. Has anyone found any difficulties a) agreeing who is data controller and b) agreeing the lawful basis for data processing for a trial?
Specifically, we have sites in Italy, the Netherlands and Germany that are suggesting that the lawful basis ought to be consent – which brings risks to the research data, and we therefore would usually avoid. They are also suggesting they should be joint controllers with us, which is not in line with how we work with sites in the NHS, nor with ICO guidance.
Has anyone else had problems like these? How have you tackled them, if so? Was it necessary to compromise on positions you’d usually take with UK sites? Have you needed to take into account any measures to plan for no-deal Brexit as part of this?
Any advice would be very gratefully received.
Thanks in advance,
Will Cragg
Regulatory and Governance Affairs Officer
Clinical Trials Research Unit
Leeds Institute of Clinical Trials Research
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