D
Diirreeccttoorraattee ooff M
Meeddiiccaall IIm
maaggiinngg &
&M
Meeddiiccaall PPhhyyssiiccss
Medical Imaging & Medical Physics ( MIMP ) Imaging Research Approval Form
In order to comply with Research Governance regulations and the Ionising Radiation Medical Exposure Regulations (IRMER) it is important
that you fully complete the form below and give detailed explanations of the examinations required including the imaging reporting
requirements.
The MIMP Directorate includes Radiology, Nuclear Medicine, MRI and Ultrasound.
The fully completed MIMP Approval form plus an electronic copy of the Protocol, Patient Information Sheet, Consent Form, study
imaging manuals and the completed IRAS NHS REC application Form Parts A&B should be emailed to sally.fleming@sth.nhs.uk and
to bridget.billingham@sth.nhs.uk Please copy all research related correspondence to both Sally and Bridget.
Questions
Full title of study and protocol version number.
STH Research Department Registration Number.
Name and Title and of Principal Investigator.
Name of Study Coordinator and contact details.
Please supply the name of the Lead Site and the name of the
Authorising Ethics Committee.
Short title to be used for Radiology Information System - RIS code (No
more than 3 words).
Study commencement date and duration (including any follow up
period).
Authors, SF/BB
Latest update 8th March 2011
Version 8
Response
D
Diirreeccttoorraattee ooff M
Meeddiiccaall IIm
maaggiinngg &
&M
Meeddiiccaall PPhhyyssiiccss
How is the study funded?
Commercial
Grant funded
Charitable funded
NCRN/SYCLRN
Other, e.g. Directorate, own account, please state
Number of patients to be recruited to the study.
Site where examinations to be performed e.g. WPH, RHH or NGH.
RESEARCH PROTOCOL IMAGING REQUIREMENTS
Include modality, area of body to be imaged and if contrast is required. Also specify any reporting and image transfer methods required;
there may be additional charges for this service.
Examination/ Scan/
Therapy Type e.g.
CT Head with
contrast
Maximum number
of examinations
per patient
Authors, SF/BB
Latest update 8th March 2011
Version 8
How many of
these are
standard of
care?
Frequency of
procedures to be
performed e.g.
Baseline, 6, 12, 18
months
Specific reporting
requirements; state if not
standard hospital report
Do you require images
copying to disc
D
Diirreeccttoorraattee ooff M
Meeddiiccaall IIm
maaggiinngg &
&M
Meeddiiccaall PPhhyyssiiccss
The following section is to be completed only if using Nuclear Medicine imaging / therapy as part of your study.
ARSAC
If you have indicated that Nuclear Medicine Imaging / Therapy will be required for your research study a research Administration Radioactive
Substance Advisory Committee Certificate – ARSAC will be required.
The application for an ARSAC Certificate requires you to answer the following questions –
.
Has a suitably trained and experienced individual been identified to
hold the ARSAC Certificate for all radiation exposures included in the
study?
If the study already has an ARSAC Certificate for another UK site then
please supply the ARSAC reference number
Does the study involve the use of a radiopharmaceutical which is not
currently in routine use within STH?
Does the study involve the alternative use of an existing
radiopharmaceutical?
Yes / No
Please give details
RPC ……/…..…/…….
Yes / No
Please give details
Yes / No
Please give details
If an IRAS form has not been completed / included we will require a one page summary of the study which should include a reference to any
test involving the administration of Radioactive Substances and the reasons why they are being used e.g. to assess disease progression or
cardio-toxicity.
If you require further information please contact –
Sister Sally Fleming
Sister Bridget Billingham
Office number - 0114 2711813 or Bleep 872.
Authors, SF/BB
Latest update 8th March 2011
Version 8