Hi everyone,
This thread didn't receive attention 3 years ago when initially posted, but I now have the same question for my own knowledge, but particularly in regards to the IMPD to be used for a CTA developed for an IIT in the UK. Would the investigator (sponsor) be responsible for developing their own IMPD for a CTA for an IIT, or is there a letter of authorization process available in the UK, as there is in the US, that the company could provide the investigator (sponsor) for their CTA in the UK?
Many thanks in advance!
------------------------------
Ashley Butler
Associate Director, Regulatory Operations
Cambridge MA
United States
------------------------------
Original Message:
Sent: 15-Jun-2020 12:18
From: Anonymous Member
Subject: Investigator Initiated Trials in the UK
This message was posted by a user wishing to remain anonymous
Dear RAPS Colleagues,
I am looking for the Investigator-Initiated Trials (IIT) regulatory process for MHRA in the UK. Do any of you have any experience regarding this pathway?
Thanks!