Angela Pizzatti

Thank you for your response. I am still unclear about what needs to be included in the "Scientific Information" section. Should I include all the studies except the two we plan to remove, even if no changes are being made to the remaining studies? The guidelines state that we should "Include only the proposed modified key elements. If key element is not changing please add N/A in the mandatory field." However, the system requires at least one entry to validate the section and proceed. Is there a way to bypass this requirement?
Thanks

I need to submit a PIP modification to remove two Studies from the initial agreed plan. When completing the field in IRIS, coming to "Scientific information" how should I complete the part : Please provide all details on each proposed study/measure to be included in the new PIP Decision. For modified studies, include the same number/code as in the latest decision received for this PIP.?

Should I add the two studies that I want to be removed? and in this case how can I make clear that these studies are not new and instead they need to be removed? Could you please advise on the correct steps to follow?