[Ed Groleau]

Reply To: Pooled supply at sites – Shipping kits without a specified protocol

Hi Nathan – Interesting idea. I did a little digging and the consensus is that this approach would not work in the EU. Without a trial alias on the label QPs would not be able to release the drug. A space to add the information at a site does not meet the regulatory requirements. The best I’ve been able to do aside from the JIT option you mention is to list multiple trials on the label with a box next to each allowing the site to indicate the trial. This approach still receives a lot of push-back though.