Carolyn Costigan and Andrea Shemilt Nottingham University Hospitals NHS Trust
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1 Carolyn Costigan and Andrea Shemilt Nottingham University Hospitals NHS Trust
2 Why we are vigilant about radiation About R&DISU Streamlining research processes involving imaging and radiation Supporting a large portfolio of trials The future implications of a single approval
3
4 Ionising radiation is used in The risks may be short term Or years in the future CT scans X-rays Nuclear medicine Radiotherapy Bone scans Some surgeries Radiotherapy side effects Skin burns from cardiology procedures Induction of solid tumours (10+ years) Induction of leukaemia (2+ years)
5 procedure Effective radiation dose CT abdomen pelvis 10mSv 1 in 2000 CT chest 8mSv 1 in 2500 Risk of inducing fatal cancer CT brain 2mSv 1 in Skull x-ray 0.07mSv 1 in Chest x-ray 0.02mSv 1 in Dental x-ray <0.01mSv 1 in a few million For comparison, we are all exposed to background radiation from day to day living around 2-3mSv per year. Our existing risk of dying of cancer is 1 in 4. Our existing risk of getting cancer is 1 in 2. Source: Patient dose information, Public Health England
6 Approval of research involving ionising radiation, NRES Ionising radiation (medical exposures) regulations, 2000.
7 proportionate response to risk informed consent in research participation
8 Radiation governance IRMER approval Technical capability Capacity Costings
9 Radiation governance What exposures are planned? Does the PIS articulate them properly? Does the R&D form match the protocol? Is the radiation risk described in the PIS? Which exposures are standard care? Which are additional? What is the patient prognosis?
10 IRMER The risk vs benefit of the radiation exposures must be justified by a Practitioner a radiologist or other expert. This person takes legal responsibility to authorise the exposures at the research site in question. Ionising radiations (medical exposures) regulations, Statutory instrument 2000 No. 1059
11 capability Do we have the equipment and skills to do these procedures? Specialised staff for procedures Specialised coils for MRI High performance CTs Availability of Radioisotopes for Nuclear medicine
12 capacity Do we have the staffing and the appointment slots to carry out the work? Are the scans time sensitive or scanner specific?
13 costings The actual procedures and Image reporting Image transfer Even routine imaging may need extra reporting for research, and this needs to be costed for.
14
15 The Research and Development Imaging Support Unit (R&DISU) was funded by the Trent Comprehensive Local Research Network to Support the Trust in improving approval times for studies involving radiation and/or imaging Facilitate the growth of imaging and radiation related research Streamline the Imaging- and Radiation- based research authorisation and operation
16 By being a contact point for information By running teaching and outreach sessions By having staffing rotas to ensure coverage of services By developing robust systems and tools for approvals and management of research imaging and radiation exposures By building relationships with support departments and developing links with different staff groups
17 number of portfolio studies approved Total portfolio studies Around 25% of studies have radiation
18 1 whole-time equivalent Medical Physics Expert 0.75 Principal research radiographer 2x 0.5 Research radiographers 1 administrator
19
20 Pre-trial support: feasibility meetings Checking radiation and imaging aspects of trials Help departments follow the research imaging protocol correctly Image anonymisation and transfer Ongoing support: amendments
21
22 Centralised hub Local staff with specialist knowledge Robust and consistent delivery R&DISU toolkit
23 Pre-trial feasibility checklist One mailbox to reach R&DISU staff and to allow us to direct enquiries and applications appropriately Required document set for applications Bespoke database to track our applications Radiation governance checklist Imaging authorisation form Specialist staff: research radiographers Imaging protocols spreadsheet for support departments
24 Giving support departments ownership of their research exposures: Write and use their own research procedures parallel processing of trials by R&DISU and the support department in question This means higher quality and safer research imaging.
25
26
27 Application Documents R&D form (or IRAS form or REC form) Protocol Participant information sheet Site specific information form Imaging authorisation form Any other documents (eg imaging manual)
28 All trials submitted to R&DISU are entered on our database
29 We scrutinise the documents and send out to support department (s) for authorisation
30 Research radiographer directs the documents to Superintendent Radiographers for capacity and technical capability Radiologists for clinical acceptability, reporting capacity and IR(ME)R Radiology business manager to check costs and inform future workload
31 place a request for trial exposures
32
33 The Administration of Radioactive Substances Advisory Committee (ARSAC) requires that any procedure involving radioactive materials be pre-authorised by them. ARSAC certificates Standard of care Research ARSAC certificates Additional procedures
34 Nuclear medicine bone scans MUGA (cardiac ejection fraction) Radium treatments I 131 therapy Iridium wire Any kind of brachytherapy GFR (glomular filtration rate)
35 IRAS dataset section B part 3 question A Research ARSAC application Authorisation of procedures at the specific site IRAS section B part 3 question A needs to have the worst case scenario for the number of procedures, so that all possible administrations are covered by the research ARSAC certificate.
36
37 ARSAC certificates are location-specific Clinician-specific Procedure-specific Issued for a specific number of patients Issued for a specific timeframe
38
39 Providing copies of images or exams that have been de-identified Image copy requests are received via our R&DISU mailbox Our staff download the images from PACS and anonymise them Delivery is via CD, DVD or secure file upload
40 DICOM images contain hidden identifiers Specialist programmes can clean and reidentify images. These may then be exported to CD or uploaded via web based secure sftp. Simply ticking the anonymise button on a workstation isn t enough
41 Target 10 working days (soon to be 5) How do we do this? Daily trial review meetings Bi monthly meetings with R&I What are our pinch points? Staffing we are a small team ARSACS Equipment replacement and capacity issues
42
43 The HRA pilot of a central scrutiny system intends to raise standards of trial documentation and reduce the need for local rebuttal. Guardians Central MPE and CRE Local review Identify radiation content of trials Collect other relevant information (eg prognosis) Use this information to complete IRAS form Articulate radiation risk on the PIS With a much lighter touch than before
44 Why we are vigilant about radiation About R&DISU Streamlining research processes involving imaging and radiation Supporting a large portfolio of trials The future implications of a single approval
45 Andrea Shemilt Carolyn Costigan Nottingham University Hospitals NHS Trust
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