This message was posted by a user wishing to remain anonymous
Hi everyone,
I work in the CRO space and when I'm apart of global studies where the client is already using an IMPD for EU I have in the past used the IMPD in lieu of the QOS for initial HC CTA for efficiency and sparing my client in billable activity as the IMPD and QOS covers the same information. However it's been a while (2 years) since I've done CTA that way and I currently don't see guidance that says you can not complete a HC CTA that way. I would like to know has any one recently completed a HC CTA using the IMPD? Did you receive a NOL? Where there any RFI/Clarifax required of you because you used the IMPD?