Northern Sydney Local Health District HREC Application for an Amendment to an Approved Research Project Submission instructions Do not submit a cover letter with this form DO NOT use this form to submit amendments to the Research Governance Officer This form must be completed electronically. Handwritten forms will not be accepted New sub-studies cannot be submitted as protocol amendments. Contact the Research Office to discuss submission requirements Proposed amendments must not be implemented prior to HREC review and approval, and (for studies post July 2007) authorisation from the local Research Governance Officer If applicable, a Methods of Payment form must be submitted with this application Per NSW GL2010_014 (section 9.5) a tracked and clean copy of all amended documents is required (including Investigator Brochures and Protocols) Incomplete submissions may be rejected or their review delayed For all applications/submissions, you must submit one complete hard copy, and email all documents to the address below. Your submission will not be processed until both the hard copy and electronic copy are received: Research Project Details NSLHD File Number xxxx-xxxM or RESP/14/xx HREC/AURED Reference HREC/year/HAWKE/xxx (or HREC/year/HARBR/xxx) Number Co-ordinating Investigator (For single centre projects, this is synonymous with Principal Investigator) Study Title Method of Payment form Yes N/A Office use: Correct Incorrect attached Do not submit without payment Sub. to Finance date/initial________ form attached (consult Fee Schedule on website) Confirm Electronic Submission Yes Office use: Received Requested All documents have been emailed to date/initial________ nslhd-research@health.nsw.gov.au List all study sites approved by Do not include sites approved by other HRECs. NSLHD HREC Details of the current study status (eg. recruitment ongoing, closed to recruitment but participants on active treatment, all participants deceased, all participants completed etc) Project Amendment Details delete RED guidance text prior to submission – Documentation submitted as part of List all documents exactly as you require them to be listed on the this amendment HREC approval letter, including updated versions and date: – a TRACKED copy of all amended documents is required Summary of issues relating to the Summarise the relevant details relating to the amendment and ongoing amendment conduct ie safety update regarding xxx; change in sample size;
Northern Sydney Local Health District HREC Application for an Amendment to an Approved Research Project Submission instructions Do not submit a cover letter with this form DO NOT use this form to submit amendments to the Research Governance Officer This form must be completed electronically. Handwritten forms will not be accepted New sub-studies cannot be submitted as protocol amendments. Contact the Research Office to discuss submission requirements Proposed amendments must not be implemented prior to HREC review and approval, and (for studies post July 2007) authorisation from the local Research Governance Officer If applicable, a Methods of Payment form must be submitted with this application Per NSW GL2010_014 (section 9.5) a tracked and clean copy of all amended documents is required (including Investigator Brochures and Protocols) Incomplete submissions may be rejected or their review delayed For all applications/submissions, you must submit one complete hard copy, and email all documents to the address below. Your submission will not be processed until both the hard copy and electronic copy are received: Research Project Details NSLHD File Number xxxx-xxxM or RESP/14/xx HREC/AURED Reference Number HREC/year/HAWKE/xxx (or HREC/year/HARBR/xxx) Co-ordinating Investigator (For single centre projects, this is synonymous with Principal Investigator) Study Title Method of Payment form attached (consult Fee Schedule on website) Yes N/A Do not submit without payment form attached Office use: Correct Incorrect Sub. to Finance date/initial________ Confirm Electronic Submission Yes All documents have been emailed to nslhd-research@health.nsw.gov.au Office use: Received Requested date/initial________ List all study sites approved by NSLHD HREC Do not include sites approved by other HRECs. Details of the current study status (eg. recruitment ongoing, closed to recruitment but participants on active treatment, all participants deceased, all participants completed etc) Project Amendment Details – delete RED guidance text prior to submission Documentation submitted as part of this amendment – a TRACKED copy of all amended documents is required List all documents exactly as you require them to be listed on the HREC approval letter, including updated versions and date: Summary of issues relating to the amendment Summarise the relevant details relating to the amendment and ongoing conduct ie safety update regarding xxx; change in sample size;
NSLHD_HREC_TemplateAmendment.docx