If you will be changing any of the information in Part B Section 3 of the
IRAS Form, you should notify Radiation Assurance of this by submitting:
This page provides guidance on how you should prepare and submit your
change/amendment to Radiation Assurance. Please note that any changes to Part B Section 3 will only be accepted through Radiation Assurance where one of the following criteria are met:
If you meet neither of these criteria then you should follow your local processes to update Part B Section 3.
For information on notifying an amendment to other relevant review bodies,
please refer to the amendment guidance for all review bodies here.
This page provides the following information:
Any changes to the study that will affect the information in Part B Section
3 will constitute a change or amendment that needs to be submitted to
Radiation Assurance. This includes, but is not limited to, any changes to
The number of scans – this can be an addition or reduction, as a result
of change in length of time participants are in follow-up, addition of
new arms to the study which include scans.
The type of scans – for instance CT may be introduced as an alternative
The dose calculation – for instance change in number of scans, new
scans or to allow for new sites having different procedures or
equipment which do not fit into the limits given in the original
Nuclear medicine procedures – for instance, changes to the radionuclide
used, on any site.
The participant group – this may affect the CRE justification.
Particular regard should be taken when adding adults aged 18-64, adults
aged over 65, children, healthy volunteers, or pregnant participants
for the first time, though the addition of other participant groups may
also require re-review.
The entry regarding the risk of ionising radiation exposure in the
participant information sheet (PIS) where this substantially alters the
meaning of the text, as this will have been previously reviewed and
authorised by the MPE and CRE.
Radiotherapy procedures – for example, changing the way the
radiotherapy is delivered, adding or removing sessions, or amending the
dose to be administered.
Other radiation exposures – these could be the use of a test that may
include exposure to ionising radiation e.g. GFR, or the inclusion or
removal of the need for biopsies that could be CT-guided.
An amendment to Radiation Assurance is not required for the following:
Substantial amendments will be processed through Radiation Assurance as any
change to the Clinical Radiation Expert (CRE) and Medical Physics Expert
(MPE) reviews will constitute a substantial amendment to the Research
Ethics Committee (REC). Where there are non-substantial changes to
documents that were reviewed as part of the Radiation Assurance process
these will not need to be notified to Radiation Assurance.
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You should submit your change/amendment to Radiation Assurance once all
proposed changes to research exposures are agreed with the sponsor but
before you submit for any other regulatory approvals. You will then need to
wait for the review to take place. Once you receive the amended CRE and MPE
reviews in the Research Exposure Form you will be able to update Part B
Section 3, obtain the necessary authorisations and proceed to submit this
part of the IRAS Form alongside your amendment to the REC and the ARSAC
You should submit the following documents affected by the change/amendment
in tracked changes (where possible):
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As Radiation Assurance occurs prior to regulatory approval submission, the
documents should be sent by email to
with the email subject “IRAS ID xxxxxx - New change/amendment submission
for Radiation Assurance”. The change or amendment should be managed in the
same way as the initial submission i.e. HRA-managed or self-managed but if
this does need to change this should be explained in the body of the email.
If an amendment is being submitted to add ionising radiation exposures for
the first time please ensure that this is clear in the body of the email.
The review process will be managed in the same way as a new submission
through Radiation Assurance – see our guidance on new submissions in the
Preparing and Submitting Applications
section of the Help pages.
When the review is completed the HRA will email you to confirm that
Radiation Assurance has been secured, and to give you further information
about what to do at this point, such as:
Copy the MPE and CRE reviews from the research exposure form into
IRAS Part B Section 3;
Seek authorisations from the lead MPE and CRE;
Make payment to the reviewing trust(s)/health board(s);
Make any changes the reviewers have requested to be made to the Participant Information Sheet;
Pre-REC favourable opinion: include this email in the submission to ARSAC (where required), and in the local information pack
to participating sites.
Post-REC favourable opinion: include this email in the amendment
submission to the regulatory bodies specified in the
Amendments for projects conducted in the NHS/HSC
section of the Help pages, the ARSAC (where required), and in the
amendment notification to participating sites.
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Page last updated: 11 November 2020
You should be aware that the standardised fee to pay for a change or an
amendment is different to that for new submissions (except for an amendment
to add ionising radiation exposures for the first time). Further guidance
on payment is available in the amendments section of the
Payments Framework Guidance.