Download Working Instruction for gathering approvals for imaging using

CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
EFFECTIVE DATE:
2014-08-01
INTENDED USERS:
Investigators seeking approval to conduct research involving
imaging modalities / CRIF / Radiology Research Governance
Committee / Nuclear Medicine / Radiation Physics / TASC
R&D approval and governance
AUTHOR:
C Weller/D Sutton/L Bidaut
REVIEW DATE:
2015-08-01
Version
Number:
Edited by (job title):
Effective
Date:
Details of edits made:
3.3a
C
Weller
Imaging
Manager
C
Weller
Imaging
Manager
C
Weller
Imaging
Manager
S
McVey
(clinical
scientist) and Mark
Ferguson
Imaging
Manager
1/7/12
Previous version
25/10/12
Revised formatting, updated
contact details
Added in section 2.3.1
3.4
3.5
4
1/5/13
1/8/14
CW
Contact details revised. Appendix 9
created.
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
Summary and Scope
This document has been produced to set out the mechanisms for notification and approval
relating to clinical research imaging within NHS Tayside and the University of Dundee.
These processes include several disparate groups across both organisations, with differing
clinical and research priorities. These include the NHS Radiology, Medical Physics and
Nuclear Medicine departments, NHS R&D as part of TASC, the Clinical Research Imaging
Facility, the Clinical Research Centre, and the College of Medicine, Dentistry and Nursing.
These processes have been discussed and agreed between the parties to provide robust and
timely approval mechanisms, for studies that may be locally-led or hosted, observational,
interventional, or involving CTIMPs or devices.
This Working Instruction is intended primarily to handle review processes for developed
projects that have defined protocols, identified funders and sponsors.
1. Confirmation of Resource Availability
1.1 Departmental Review Routes
All imaging using X-ray, CT, MRI, PET-CT or Nuclear Medicine should be passed to the
appropriate group for review and approval (see appendix 1 for contacts).
Choice of location
If the imaging location for radiological examinations is not clear, either the Radiology
Research & Training coordinator or the CRIF manager can advise, taking into account the
following





The investigator or sponsor may specify the location of the imaging activity
There may be an equipment requirement, such as 3T or 1.5T MRI.
Studies requiring intensive research support are recommended for CRC
Scans that are largely carried out as they would be in routine clinical practice are
recommended for the NHS department.
The CRIF PET-CT scanner may be used to meet tight dose constraints in CT scans
that would otherwise not be possible on NHS equipment.
Please note that separate approvals will be required for studies that make use of multiple
locations – the CRIF Manager or the Radiology Research & Training coordinator can assist
with these if necessary.
Clinical Research Imaging Facility
CRIF, based on level 5 of the CRC building, hosts the 3T MRI and PET-CT scanners, and
can also carry out CT scans.
A copy of the protocol, and any associated documentation, should be passed to the Imaging
Manager, either by email, or using the CRIF application form on the TASC website:
http://www.tasc-research.org.uk/_page.php?id=127
The CRIF Imaging Manager will review the proposal, which will include confirmation of
technical capability and costing, and signoff, using the CRIF Proposal form (appendix 3).
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
All studies involving the use of stand alone CT or MRI will require the identification to CRIF of
a named radiologist who has agreed to provide a report. Investigators are encouraged to
liaise with potential radiologists.
The person who has agreed to report PET/CT images must also be identified to CRIF.
A copy of the completed and signed form will be forwarded to the appropriate R&D
commercial or non-commercial manager, and a copy provided to the Principal Investigator (or
study contact).
NHS Radiology
NHS Radiology hosts 1.5T MRI, routine CT, X-ray, and Ultrasound.
The NHS Radiology Research and Training Officer will pass applications for research using
these modalities for review by the monthly Radiology Research Governance Group for
approval, using the Radiology Costing Form (appendix 4). This Group meet monthly, so it is
recommended that this be taken into account when considering startup timelines.
A submission can be made to the Radiology Research & Training coordinator by mail or
email, enclosing a copy of the protocol, and a completed Radiology Costing Form.
All studies involving the use of x-rays, CT, MRI or ultrasound will require the identification on
the costing form of a named radiologist who has agreed to provide a report. Investigators are
encouraged to liaise with potential radiologists.
Once a project has been favourable reviewed by the Radiology Research Governance
Committee, a letter confirming the approval will be sent to the appropriate commercial or noncommercial R&D manager, and a copy sent to the Principal Investigator (or study contact).
Nuclear Medicine
All proposals for studies involving Nuclear Medicine, for example, MUGA scans, bone scans,
DaTSCANs or other investigations provided by the department must be discussed in the first
instance with the Consultant Physicist in Nuclear Medicine.
1.2 Approval and notification
Once approval has been received from CRIF and/or Radiology, by signature of the
appropriate form, the PI (CI if locally-led, or other appropriate study contact) and R&D will be
notified by the CRIF manager, or Radiology Research & Training coordinator.
Receipt of a signed Radiology costing form or CRIF Proposal Form confirms availability of
resource, technical feasibility, and of associated costs. Additional NHS support costs for noncommercial eligible studies may be identified and costed as part of the NHS approval
process.
For studies involving Nuclear Medicine, a signature will be required on the SSI form to confirm
support,
Receipt of the approval CRIF form and/or NHS Radiology letter can be considered
equivalent to an SSI signature, provided that the protocol versions are the same.
Confirmation of availability does NOT mean that the project has ARSAC or IRMER
approval to scan.
RRG or CRIF do not need ARSAC or RPD approval in order to issue imaging approval –
these are governance issues for R&D/NHS Management approval to take into account.
2. IRMER
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
IRMER approval is required for all ionising radiation occurring during a clinical study, whether
routine or not. This means any exposure noted in the protocol.
The use of the forms discussed below is a local mechanism to show compliance with this
national legislation, so specific mechanisms may differ at other sites across the UK.
To apply for IRMER approval, choose from one or more of the following forms ( but see below
for singles site studies or studies that are locally led:
2.1 X-rays and standalone CT scans (including those on PET scanner in CRC)
Use a Radiation Protection Diagnostic (RPD) form – appendix 5.
This should be completed and passed to the contacts noted on the form – appendix 9.
2.2 PET-CT scans, (including CT as part of PET scan)
Use Radiation Protection PET (RPP) form – appendix 6.
This should be completed and passed to the contacts noted on the form– appendix 9.
2.3 Nuclear Medicine exposures: MUGA, SPECT, DXA
Use the Radiation Protection Nuclear (RPN) form – appendix 7
This should be completed and passed to the contacts noted on the form– appendix 9.
A completed form for each type of exposure should be submitted to the contact detailed on
the form, together with the following documents;
i.
ii.
iii.
iv.
RPD, RPP and/ or RPN Form (as noted above), completed using the instructions on
the form itself
Patient Information Sheet
IRAS part B section 3
Protocol
The Radiation Protection Therapeutic Form (RPT) is used for therapeutic exposure approvals
by the Head of Radiotherapy Physics, but is not covered in this WI. Exposure will be
significantly greater than for diagnostic purposes.
Local Medical Physics Experts will review the study protocol and the above forms, and will
communicate with each other to ensure that the cumulative dose has been considered.
A copy of the fully signed form must be provided to R&D as part of the documentation
required for R&D approval. R&D Management Approval must not be issued unless an
appropriate IRMER compliance form has been received.
3. ARSAC
ARSAC is a national licensing system for the administration of radioactive medicinal products
to humans. It operates on an individual licensing basis: per study, and per person. It can take
up to 6 weeks to procure, so should be requested as early as possible. An ARSAC certificate
is only required for research activities which are additional to routine care.
An ARSAC license is required for PET-CT, MUGA, and any of the Nuclear Medicine
procedures involving the administration of radioactive medicinal products to humans.
The ARSAC Licence holder should be contacted, and provided with IRAS form part B4, which
can be generated from the online IRAS system.
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
Please also supply the ARSAC Licence holder with a summary of the radiation and
imaging activity in a Word document – this can be generated from the IRAS
submission text.
The ARSAC Licence holder maintains parts A and C of ARSAC on a template, and will review
the information provided by the applicant, and apply for the certificate.
If Tayside is the lead site for the study, early contact with the ARSAC Licence holder is
recommended.
A copy of the fully signed ARSAC License must be provided to R&D as part of the
documentation required for R&D approval. R&D Management Approval must not be
issued unless an appropriate ARSAC certificate has been received.
4. R&D approval
As for all clinical research, the normal routes for an ethical favourable opinion and R&D/ NHS
Management approval apply.
The NHS R&D office, as part of TASC, is responsible for ensuring that the necessary
approvals for imaging work are in place before NHS management approval is issued.
The responsibility for gathering the imaging approvals noted above does not lie with R&D.
Although R&D may assist in order to expedite approval, the primary responsibility lies with the
local investigator and their study team.
A checklist is attached at appendix 8 to assist R&D and study teams in identifying the
necessary approvals for any given study.
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
Further Information
1. IRAS guidance:
https://www.myresearchproject.org.uk/help/IrasPartBSectionThreeCollatedHelp.aspx
2. NRES guidance
http://www.nres.nhs.uk/applications/guidance/research-guidance/?1311971_entryid62=67014
3. ARSAC home page:
http://www.arsac.org.uk/
4.
IRMER regulations 2000:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidanc
e/DH_4007957
5. TASC Imaging webpage
http://www.tasc-research.org.uk/_page.php?id=127
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
Glossary
1.5T/3T
1.5/3 Tesla (measurement of magnetic field strength)
ARSAC
The Administration of Radioactive Substances Advisory Committee
Bone Scan
Bone scintigraphy – involves administration of radioisotopes. Not to be
confused with DEXA; may require SPECT.
CI
Chief Investigator
CRIF
Clinical Research Imaging Facility
CT
X-ray Computed Tomography
CTIMP
Clinical Trial of an Investigational Medicinal Product
DaTSCAN
Ioflupane (123I) (used in the diagnosis of Parkinson’s Disease)
DXA/DEXA
Dual-energy X-ray absorptiometry (used in analysing bone mineral density
– not to be confused with a Bone Scan)
IRAS
Integrated Research Approval System
IRMER
The Ionising Radiation (Medical Exposure) Regulations 2000
MRI
Magnetic Resonance Imaging
MUGA
Multi Gated Acquisition Scan
NHS R&D
The NHS R&D Office, part of TASC
PET
Positron Emission Tomography
PI
Principal Investigator
RPD
Radiation Protection (Diagnostic) Form
RPP
Radiation Protection (PET) Form
RPN
Radiation Protection (Nuclear Medicine) Form
RPT
Radiation Protection (Therapeutic) Form
RRG
Radiology Research Governance
TASC
TAyside medical Science Centre
SSI
Site Specific Information Form (IRAS submission to R&D)
SPECT
Single-photon emission computed tomography
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CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Revision:
4
Appendix 1
Key Imaging Contacts
Last revision: 4th May 2012
Role
CRIF Director / Head,
Division of Imaging &
Technology
TASC imaging
manager / CRIF
Imaging Manager
Radiology Research
and Training
coordinator
Joint Clinical
Director Diagnostics
Physicist Nuclear
Medicine
Location
CRIF
Name
Prof Luc
Bidaut
CRIF/TASC
Dr Mark
Ferguson
email
[email protected]
extension
40246
NHS
Radiology
Norma
Gourlay
[email protected]
7783845
(83845 from
Uod)
36210
NHS
Radiology
Dr Gavin
Main
[email protected]
32661 / 35535
Nuclear
Medicine
Clare
Monaghan
[email protected]
Physicist Nuclear
Medicine
Radiation Physicist
Nuclear
Medicine
Radiation
Physics
Glen Gardner
[email protected]
40479
Siobhan
McVey
[email protected]
32604
NHST Radiation
Protection Adviser
Radiation
Physics
Dr David
Sutton
[email protected]
32794
ARSAC Licence
holder
PET-CT &
Nuclear
Medicine
Dr John
Davidson
[email protected]
33888
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[email protected]
36610
CLINICAL RESEARCH IMAGING FACILITY
WORKING INSTRUCTION:
IMG/WI001
TASC Imaging Approvals
Appendix 2
Summary Flowchart
(v1.1 21/5/12)
Appendix 3
CRIF Proposal form
(v1.1 28/3/12)
Appendix 4
RRG Costing form
(v1.1 13/1/09)
Appendix 5
RPD
V11 July 2014
Appendix 6
RPP
V6 July 2014
Appendix 7
RPN
V3 July 2014
Appendix 8
R&D Imaging Checklist
(v1.3 18/6/12)
Appendix 9
Authorised Signatories
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Revision:
4