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9d. UHL IMAGING CBU RESEARCH PROPOSAL FORM – Instructions for completion This form must be completed by the investigator of a new research study that requires patients to undergo tests performed by the Imaging CBU / Nuclear Medicine department. Please include a copy of the study protocol with this form. STUDY TITLE: Full title Short title: Please place a short, consistent, title here that we can use to identity the trial on request forms Investigator: Lead Investigator name Is the trial funded and by who? What is the funding for the radiological tests? If no funding, why not? State funding for tests UHL Site: Site at which Imaging will be conducted State reasons: e.g. imaging would have been performed anyway, standard management, Imaging CBU agreed to cover costs etc. Proposed start date: Proposed end date: Number of patients: This is the number of anticipated patients at UHL only Investigations required: Imaging Protocol Frequency / Timing ~ no: Ix per patient Specific protocol for imaging, if it is not stated we may do the wrong thing. For example: Chest x ray Standard PA PA and Lateral Baseline, visit 6, end of study 3 Ultrasound Abdomen / Pelvis / Liver Screening 1 CT or MRI eg Chest / Abdomen / Pelvis / Head / Neck etc None Specified / Standard Reported to RECIST/ WHO etc Baseline, Screening, end of cycle 3, 6 etc 6 PET CT Eg Base of Brain to groin / Local protocol Screening, 6 months, 1 year 3 Nuclear Medicine: Bone Scan / Isotope scan / Dexa / Muga None Specified / Standard Screening, 1 year 2 Are there any additional archive requirements? If yes, please give details. If images are required for external review please state number of CDs and frequency of submitting data etc. Revised Jan 2011 Are these investigations part of normal medical management? *Advice should be obtained from the Radiation Protection Advisor Investigation EITHER Indication If so please give indication If not please give estimated dose OR Dose reference limit* 1: List clinical indication 2: e.g. Brain CT Possible brain metatases 3: CXR Normal volunteer 4: eg CT visits 3 & 6 Above standard care, required for study protocol. Seek advice from Radiation Protection Advisor PRINT NAME: SIGNATURE: Must be lead investigator. This is a legal form to justify imaging tests Must be signed by lead investigator CONTACT NO: DATE: Please sign and send original to: Professor B. Morgan Radiology Dept Leicester Royal Infirmary Please sign and send original copy to Professor B Morgan. (Copy email may be sent if required). IMAGING APPROVED BY DATE: COMMENTS Once approved by Imaging CBU you will be required to send this form with your R&D application Revised Jan 2011