For commercially sponsored, multi-centre studies that involve non-SCHN sites - Medicines Australia Form of Indemnity (HREC review only) Please refer to this link for Medicines Australia indemnity forms and guidelines: . The indemnity form must be provided by an Australian corporate entity. This may be: An Australian company; or An Australian company that is subsidiary of an overseas parent company; or An Australian contract research organisation (CRO) that has been engaged by an overseas or Australian company to conduct the trial in Australia. The indemnified party details must be completed as per the following: Sydney Children’s Hospitals Network (Randwick and Westmead) “The ABN: 53 188 (incorporating The Royal Alexandra Hospital for Children), 579 090; a Statutory Health Corporation incorporated under the Health Services Act 1997 of Hawkesbury Rd and Hainsworth St, Westmead, NSW, 2145 (“the Health Service”).” Step 2 SAC and HREC Meetings – Your application will be listed for review by the SAC and HREC on consecutive meeting days. Step 3 Combined SAC and HREC Feedback – A single combined SAC and HREC feedback letter is issued to investigators within one week of the published HREC meeting date. Multi-jurisdictional low and negligible risk (LNR) research projects Page three (3) of this guideline provided an explanation regarding multi-jurisdictional LNR research projects. This section will outline the submission process for this type of NEAF applications. Step 1 Submission Closing Date – Submit application via email to on the SAC & HREC submission closing date. The application should contain the following documentation. The submission email should be from a valid organisational email address (e.g. not Gmail/Hotmail). National Ethics Application Form (NEAF) completed online at , downloaded – and emailed as an original PDF (i.e. not scanned) Electronic signatures or scanned signature page. This link provides guidance for obtaining electronic signatures on the online forms website:
For commercially sponsored, multi-centre studies that involve non-SCHN sites - Medicines Australia Form of Indemnity (HREC review only) Please refer to this link for Medicines Australia indemnity forms and guidelines: . The indemnity form must be provided by an Australian corporate entity. This may be: An Australian company; or An Australian company that is subsidiary of an overseas parent company; or An Australian contract research organisation (CRO) that has been engaged by an overseas or Australian company to conduct the trial in Australia. The indemnified party details must be completed as per the following: “The Sydney Children’s Hospitals Network (Randwick and Westmead) (incorporating The Royal Alexandra Hospital for Children), ABN: 53 188 579 090; a Statutory Health Corporation incorporated under the Health Services Act 1997 of Hawkesbury Rd and Hainsworth St, Westmead, NSW, 2145 (“the Health Service”).” Step 2 – SAC and HREC Meetings Your application will be listed for review by the SAC and HREC on consecutive meeting days. Step 3 – Combined SAC and HREC Feedback A single combined SAC and HREC feedback letter is issued to investigators within one week of the published HREC meeting date. Multi-jurisdictional low and negligible risk (LNR) research projects Page three (3) of this guideline provided an explanation regarding multi-jurisdictional LNR research projects. This section will outline the submission process for this type of NEAF applications. Step 1 – Submission Closing Date Submit application via email to on the SAC & HREC submission closing date. The application should contain the following documentation. The submission email should be from a valid organisational email address (e.g. not Gmail/Hotmail). National Ethics Application Form (NEAF) – completed online at , downloaded and emailed as an original PDF (i.e. not scanned) Electronic signatures or scanned signature page. This link provides guidance for obtaining electronic signatures on the online forms website:
neaf_quick_submission_guideline_-_v3_-_dec_2016_0.docx