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Research project or protocol with imaging*

Combined Imaging Approval Process V 1.2 25 June 2012. Research project or protocol with imaging*. Does the project involve using ANY Ionising radiation?. Radiation involved: IRMER Applies (PET/CT, CT, X-ray, etc). No radiation : MRI / Ultrasound ONLY.

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Research project or protocol with imaging*

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  1. Combined Imaging Approval Process V 1.2 25 June 2012 Research project or protocol with imaging* Does the project involve using ANY Ionising radiation? Radiation involved: IRMER Applies (PET/CT, CT, X-ray, etc) No radiation: MRI / Ultrasound ONLY. No requirement for radiation protection forms Single site study, or lead for a multisite study? Multisite Lead: Complete full IRAS form, seek (M)REC Approval Choose PET-CT, Nuclear Medicine, or CT/X-ray. PET/CT or Nuclear Medicine (e.g. MUGA) ARSAC Applies : Research ARSAC certificate required for research activities additional to routine care CT or X-ray If there are no radiopharmaceutic-als, no ARSAC certificate will be required ARSAC License holder will send submission to ARSAC Complete RPP/RPD/RPN** form for each type of radiation exposure, even if routine Choose imaging location(s) **A separate RPT assessment applies if radiotherapy is required REC Approval Process Up to 10 working days to review and signoff NHS Nuclear Medicine: MUGA, bone scan, etc. Contact Consultant Physicist in Nuclear Medicine. Clinical Research Imaging Facility (CRIF): CT. 3T MRI, PET-CT Pass protocol to CRIF Manager, or use website NHS Radiology: CT, 1.5T MRI, X-ray Pass protocol plus Radiology Costing Form to Radiology Research administrator ARSAC approval can take up to 6 weeks Required BEFORE SSI submitted NHS R&D Approval Process CRIF: Up to 10 working days Radiology meets monthly Technical and resource availability consideration Technical and cost review Radiology Costing Research Governance review and signoff SSI signature Signed CRIF Proposal Form confirms CRIF costs and support Letter from RRG Chair confirming approval, confirms Radiology support Copies to PI and R&D: Equivalent to SSI signature R&D review ARSAC/IRMER and location approvals for NHS Management Approval *Process flow assumes that funding and sponsorship issues have been addressed in advance: The department providing the resource should be involved at these earlier stages, if required for the study.

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