CTIMPs
If the site was not included in the list of proposed
trial sites in the original REC application, then sponsors (or their
representatives) must submit the European Commission Notification of
Amendment Form to the main REC only. There is no requirement to notify
the MHRA.
If the new site or
principal investigator is within the NHS or Health and Social Care (HSC)
in Northern Ireland, the main REC will confirm a favourable opinion
within five working days on condition that permission is given by the
R&D office at the site. There is no need to submit a Site-Specific
Information (SSI) Form to a local REC for Site-Specific Assessment
(SSA).
If the new site or principal investigator is outside the
NHS / HSC, you should submit the SSI Form to the relevant local REC for
SSA, together with the supporting documents listed in the checklist for
non-NHS site SSA in IRAS. The 35-day clock for review of the amendment
starts when both a valid application for SSA and the notice of amendment
have been received.
The main REC will acknowledge receipt of the notice of
amendment. The local REC will acknowledge receipt of a valid application
for SSA and will notify the main REC whether or not there is any
objection and the main REC will then issue an opinion to the chief
investigator within 35 days. A copy will be sent to the sponsor and the
MHRA will be notified by NRES so that it has an up-to-date list of all
approved trial sites in the UK. .
All other research
If the new site or principal investigator is within the
NHS or Health or Social Care (HSC) in Northern Ireland, there is no need
to notify the main REC or apply for SSA to a local REC. All NHS sites
and investigators are approved as part of the favourable opinion for the
study on condition that permission is obtained from the R&D office
for the site.
If the new site or principal investigator is outside the
NHS / HSC, the procedure depends on whether the study requires
Site-Specific Assessment (SSA). Studies normally require SSA if they are
medical device studies, other clinical trials or investigations, or
studies involving adults lacking capacity to consent for themselves. The
main REC may exempt some studies or individual sites from SSA in
certain circumstances. Please check with the main REC if you are unsure
whether SSA is required.
If the study requires SSA, you should submit the SSI
Form for a new non-NHS site to the relevant local REC for SSA, together
with the supporting documents listed in the checklist for non-NHS site
SSA in IRAS. (It is not necessary to submit a notice of substantial
amendment to the main REC.) The local REC will acknowledge receipt of a
valid application for SSA. It will undertake the SSA and notify the main
REC within 25 days whether or not there is any objection. The main REC
will then issue an opinion to the chief investigator within 35 days. A
copy will be sent to the sponsor.
If the study does not require SSA, the sponsor may add
the new site or principal investigator as soon as the study has
permission from the organisation responsible for the site. There is no
need to notify the main REC or apply for SSA. All sites and principal
investigators are deemed to be approved within the terms of the
favourable opinion from the main REC.
