Office Use Only Routine Active HREC/Billing No:_________ RADIOLOGY, NUCLEAR MEDICINE & RADIATION ONCOLOGY SERVICES Any projects involving radiation oncology, nuclear medicine or radiology services must have a declaration from the relevant Resource Centre Manager. The form below is to be completed and signed before submission to the Ethics Committee. Before completing the form please read ‘Radiology & Nuclear Medicine Department Guidelines: Services for Clinical Trials’ document. Please list all required tests and attach a summary protocol and imaging protocol. DECLARATION FROM RESOURCE CENTRE MANAGER Resource Service you require (check all that apply): Radiology & MRI Resource Centre Manager: Helen Kavnoudias Email: RadSafeRes@alfred.org.au Victor Kalff Email: v.kalff@alfred.org.au Nuclear Medicine Resource Centre Manager: Radiation Oncology (William Buckland Radiotherapy Centre) Resource Centre Manager: Robin Smith Email: robin.smith@wbrc.org.au Section 1 Project Details: Short Title: Alfred HREC Number: Department/Unit requesting: Principal Investigator: Coordinator: (Request will not be processed without this number) Extension: Extension: Email: Expected commencement date: Expected completion date: Expected recruitment completion date: Submission date for The Alfred HREC approval? Resources Required: Imaging (e.g. CT abdomen) If requesting CT please specify with or without contrast No. of Patients Imaging schedule (e.g. baseline, 3month, annually) Is the test additional to routine patient care? Estimated cost (Radiation Services Centre to complete) † * Y/N † Please note that these estimated costs are exclusive of GST. Please see note on Page 3 regarding applicability of GST. *Please describe the routine patient care: E.g. CT every 8 weeks for 48 weeks Author: Research Coordinator Approved by: Research Coordinator Location: H:\Policy & Procedures\Research Unit Control Number: F-RAD-264/1-01 Approval Date: June 2013 Page 1 of 3 Review Date: June 2016 RADIOLOGY, NUCLEAR MEDICINE & RADIATION ONCOLOGY SERVICES Section 2 Please complete all questions below Do you require a study specific imaging protocol (see guidelines for explanation, commercial sponsors usually provide an imaging protocol separate to the main study protocol) Will you require a CD of the images (DVD available on request from Nuc Med) If yes, do they need to be de-identified? How many discs are required per patient visit? What information is to be printed onto the disc? Yes No Yes Yes No No Do you require more than a standard patient report? E.g. RECIST If yes, please provide the name or send the reporting protocol Yes No Do you require reporting by a specific consultant? If yes, please provide name Yes No Do you require a print out of the patient report? If yes, Name of requesting doctor Copies to: Yes No Do any study specific forms need to be completed by radiation services? Yes No If yes, please provide a copy of the forms (NB: radiation services staff will not complete CRFs or organise shipment of digitised data to sponsor) For CT imaging do you require 3D reconstruction of your images? Yes No N/A For PET imaging do you require SUV measurements? Yes No N/A Will you require any other image measurements If yes, please specify Yes No Will you require a ‘data dump’ of your imaging? If yes, how frequently Yes No Will you require QC imaging data to be sent to the sponsor ? If yes, how frequently? Yes No Will you require a NATA Accreditation Certificate Yes No Will you require a signed copy of Head of Department CV Yes No Author: Research Coordinator Approved by: Research Coordinator Location: H:\Policy & Procedures\Research Unit Control Number: F-RAD-264/1-01 Approval Date: May 2015 Page 2 of 3 Review Date: June 2016 RADIOLOGY, NUCLEAR MEDICINE & RADIATION ONCOLOGY SERVICES Section 3 Funding, Fees & Account Details: For explanation of fee structure please see ‘Radiology & Nuclear Medicine Department Guidelines: Services for Clinical Trials’ External Sponsor: Yes No If yes, Name of Sponsor: Research Funding Agency: NHMRC Other (specify): Internal, not sponsored: Yes No Billing Details For Establishment Fees (if the ICAN/ECAN form is not completed your project will not be reviewed): Person responsible for account payment: Establishment Fee payment from Alfred Health Cost Centre (please complete ICAN on Page 4) ($150 for internal & funding agencies, from Sponsor or external account (please note this will incur GST $350 for externally sponsored trials) charges) (please complete ECAN on Page 5) Billing Details For Imaging Fees: Imaging Fee payment from Alfred Health Cost Centre (number to be debited: ) from Sponsor or external account (please note this will incur GST charges) For imaging fee invoices direct to Sponsor provide contact details: Section 4 To be completed by the Resource Centre Manager: Short Title of Project: Radiation Services: Signature:...............……................................................................................... Date:……………. Name: ………………………………………………………………………………… Ext:………….….. Undertaking by Chief Investigator of the trial: Agrees to look after all funding arrangements between The Alfred and the sponsoring body; Agrees to ensure that adequate funds are available and that payments of invoices are from an Alfred hospital cost centre or special purpose fund and will cover all the agreed costs within the time frames set out by the servicing unit; Agrees to any conditions outlined by the supporting department; Knows that default of payment may prejudice approval of future trials; Will contact the supporting service at commencement of the trial; Agrees if the trial has not commenced within 6 months of the costing date, will re-confirm prices with the supporting department; Agrees to notify the relevant support services upon completion of the trial. Signature of Chief Investigator..….................................................................. Date:.................. Name:………………………………………………………………………………………………………………………………… Author: Research Coordinator Approved by: Research Coordinator Location: H:\Policy & Procedures\Research Unit Control Number: F-RAD-264/1-01 Approval Date: May 2015 Page 3 of 3 Review Date: June 2016 ICAN NO _ _ BAYSIDE HEALTH FINANCE USE ONLY JOURNAL : INTERNAL CHARGE ADVICE NOTE PERIOD : PLEASE COMPLETE ALL SHADED AREAS BATCH/TRANS: PLEASE CHARGE (DEBIT) COST CENTRE DESCRIPTION ALF DELETE NOT APPLICABLE ST.G CG PJ C C/CENTRE 5 FINANCE USE ONLY FINANCE USE ONLY TOTAL DEBIT DESCRIPTION OF CHARGES 0 0 0 0 0 0 DEFINITIVE 0 9 0 2 1 1 PLEASE REIMBURSE (CREDIT) COST CENTRE DESCRIPTION ALF JOURNAL NO.: DELETE NOT APPLICABLE ST.G CG PJ C C/CENTRE 5 FINANCE USE ONLY FINANCE USE ONLY TOTAL CREDIT 0 0 0 0 0 0 DEFINITIVE 0 9 0 2 1 1 Radiology/Nuclear Medicine Services Establishment Fee: (insert HREC number and project title) (Resource Centre Manager will submit ICAN to Finance) CERTIFICATION DEPARTMENT(S) CHARGED AUTHORISATION DEPARTMENT(S) REIMBURSED AUTHORISATION SIGNATURE : SIGNATURE : PRINT NAME : PRINT NAME : COST CENTRE : COST CENTRE : DATE : DATE : BOTH GST EXTERNAL CHARGE ADVICE NOTE (ECAN) (This is not an invoice) No: PLEASE CHARGE Requesting Department ADDRESS/ABN/UR No.: Contact Ext. No. Cost Centre ATTENTION OF DATE AMOUNT DESCRIPTION $ Radiology/Nuclear Medicine Services Establishment Fee (HREC No. & Project Title: ) GST $ $ 0 00 0 00 TOTAL VALUE Grand Total Including GST: ACCOUNTS USE ONLY (Please complete shaded areas. Resource Centre Manager will submit ECAN to Finance.) Authorised By Debtor Code Received By Invoice No. Date Date TOTAL ACCOUNT TO BE CREDITED