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    12. Resources (listed in descending order of precedence)
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    12. Resources (listed in descending order of precedence)

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    1. NHMRC (National Health and Medical Research Council) (2018) ‘Australian Code for the Responsible Conduct of Research’, NHMRC, Australian Government, https://www.nhmrc.gov.au/file/14384/download?token=gje4DNtT
    2. TGA (Therapeutic Goods Administration)(2020) ‘Application for approval to import/export unapproved therapeutic goods for experimental purposes in humans’, Publication no. d20-3559609, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/sites/default/files/importexport-unapproved-therapeutic-goods-experimental-application-purposes-in-humans-form.pdf
    3. TGA (Therapeutic Goods Administration)(2022) ‘Application for a permit to export human substances’, Department of Health and Aged Care, Australian Government. https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=permit-to-export-hum&tmFormVersion
    4. DHAC (Department of Health and Aged Care)(n.d.) ‘Apply for a DIR licence’, DHAC, Australian Government. https://www.ogtr.gov.au/apply-gmo-approval/apply-dir-licence
    5. DHAC (Department of Health and Aged Care)(n.d.) ‘Apply for a DNIR licence’, DHAC, Australian Government. https://www.ogtr.gov.au/apply-gmo-approval/apply-dnir-licence
    6. DHAC (Department of Health and Aged Care)(2022) ‘Guidance for conducting human clinical trials involving GMOs’, DHAC, Australian Government. https://www.ogtr.gov.au/sites/default/files/2022-10/guidance_for_conducting_human_clinical_trials_involving_gmos.pdf
    7. TGA (Therapeutic Goods Administration)(2021) ‘Australian Clinical Trial Handbook – Guidance on conducting clinical trials in Australia using ‘unapproved’ therapeutic goods’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/sites/default/files/australian-clinical-trial-handbook.pdf
    8. Australia and New Zealand Clinical Trial Registry (ANZCTR)(n.d) Frequently Asked Questions, ANZCTR, accessed 8 November 2022.
    9. National Health and Medical Research Council (NHMRC)(2019) ‘Management of Data and Information in Research – a guide supporting the Australian Code for the Responsible Conduct of Research, NHMRC, Australian Government. https://www.nhmrc.gov.au/sites/default/files/documents/attachments/Management-of-Data-and-Information-in-Research.pdf
    10. National Health and Medical Research Council (NHMRC)(2016) ‘Safety monitoring and reporting in clinical trials involving therapeutic goods’, NHMRC, Australian Government. https://www.nhmrc.gov.au/file/2891/download?token=SxYSaQ2D
    11. Therapeutic Goods Act 1989 (cth) https://www.legislation.gov.au/Details/C2021C00376
    12. Victoria Guidelines for Teletrials https://www.clinicaltrialsandresearch.vic.gov.au/teletrials 
    13. Queensland Guidelines for Teletrials https://www.health.qld.gov.au/research-reports/research/researchers/how-to/teletrials
    14. NSW Guidelines for Teletrials https://www.slhd.nsw.gov.au/rpa/research/teletrials.html
    15. Release of Teletrials in WA https://www.medicaldevice-network.com/news/western-australia-teletrial-programme-regional-patients/
    16. South Australia Guidelines for Teletrials https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/health+and+medical+research/clinical+trials/teletrials
    17. Northern Territory Guidelines for Teletrials https://health.nt.gov.au/data-and-research/nt-health-research/teletrial-program
    18. Medicines Australian Tools for Teletrials https://www.medicinesaustralia.com.au/policy/clinical-trials/tele-trials/
    19. ARCS White Paper on Terminology for DCTs https://www.arcs.com.au/public/153/files/News/DIRT%20White%20Paper%20of%20Definitions%20FINAL.pdf
    20. Rogers A, De Paoli G, Subbarayan S, Copland R, Harwood K, Coyle J, Mitchell L, MacDonald T, Mackenzie I (2022) ‘A systematic review of methods used to conduct decentralised clinical trials’ British Journal of Clinical Pharmacology, 88(6): 2843–2862,doi: 10.1111/bcp.15205
    21. Department of Health (n.d.) Making submissions to the Department of Health HREC, Department of Health, accessed 10 November 2022.
    22. Checklist – Determining Review Pathway (LNR or Full HREC Review)
    23. Mater Research (n.d) Method and timeline for review of HREC submissions, Mater Research, accessed 10 November 2022.
    24. St Vincent’s Hospital (n.d) Research Valet, St Vincent’s, accessed 11 November 2022.
    25. NHMRC (National Health and Medical Research Council) (n.d), Apply for HREC registration, accessed 11 November 2022.
    26. Monash Health (2022), Human Research Ethics Application, Monash Health, accessed 8 November 2022.
    27. Monash Health (n.d), Indemnity & Compensation Guidelines, Monash Health, accessed 8 November 2022.
    28. TGA (Therapeutic Goods Administration)(17 August 2021) ‘Regulatory framework for biologicals’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/regulatory-framework-biologicals
    29. TGA (Therapeutic Goods Administration)(27 June 2022) ‘Schedule of fees and charges’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/how-we-regulate/fees-and-payments/summary-fees-and-charges/schedule-fees-and-charges
    30. TGA (Therapeutic Goods Administration) (n.d) Login to TGA Business Services, Department of Health and Aged Care, Australian Government. https://adfs.tga.gov.au/adfs/ls/?wtrealm=https%3a%2f%2fbusiness.tga.gov.au&wctx=WsFedOwinState%3dk4fk9URQ0v-Ul0BVyRGFpaOOAVbOtmF_o4PddLr2ptw6f40Od1NdHbkIUnasKqmx109_D0ksG6CgtumTcIOvyuj5ASYkIcVQLYUYD_qfJPkeAYSBf11J5Fh8CetAv_7q&wa=wsignin1.0
    31. TGA (Therapeutic Goods Administration)(27 June 2022) ‘Clinical trial notification (CTN) form – user guide’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/sites/default/files/clinical-trial-notification-ctn-form-user-guide.pdf
    32. NHMRC (National Health and Medical Research Council) (2019) ‘Management of Data and Information in Research’, NHMRC, Australian Government, https://www.nhmrc.gov.au/sites/default/files/documents/attachments/Management-of-Data-and-Information-in-Research.pdf
    33. Privacy Act 1988 (cth) https://www.legislation.gov.au/Series/C2004A03712
    34. Department of Health (2023) ‘National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia' https://www.health.gov.au/sites/default/files/2023-07/national-standard-operating-procedures-for-clinical-trials_0.pdf
    35. Pharmaceutical Inspection Convention (1 February 2022) ‘Guide to good manufacturing practice for medicinal products annexes’, Pharmaceutical Inspection Convention, accessed 8 November 2022.
    36. TGA (Therapeutic Goods Administration)(April 2013) ‘Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/resources/publication/publications/australian-code-good-manufacturing-practice-human-blood-and-blood-components-human-tissues-and-human-cellular-therapy-products
    37. Department of Health and Aged Care (n.d.) ‘Office of Drug Control’, Office of Drug Control, Australian Government. https://www.odc.gov.au.
    38. Customs (Prohibited Exports) Regulations 1958 (cth) https://www.legislation.gov.au/Series/F1996B03403
    39. TGA (Therapeutic Goods Administration) (n.d.) ‘Regulation basics’, Department of Health and Aged Care. https://www.tga.gov.au/regulation-basics
    40. Quarantine Act 1908 (cth) https://www.legislation.gov.au/Series/C1908A00003
    41. TGA (Therapeutic Goods Administration)(25 September 2021) ‘Import/export of unapproved therapeutic goods for experimental purposes’, Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/resources/resource/forms/importexport-unapproved-therapeutic-goods-experimental-purposes
    42. The Department of Health and Aged Care (21 September 2020) ‘Australia’s Human Biosecurity Portal – Bringing in or Exporting Human Remains or Ashes’, Department of Health and Aged Care, Australian Government. https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-biosec-human-remains.htm
    43. Australian Border Force (ABF) (n.d.) Australian Border Force, ABF, accessed 12 November 2022.
    44. NHMRC (National Health and Medical Research Council) (n.d.), ‘Import and export of cell lines from human embryo clones’ NHMRC, Australian Government. https://www.nhmrc.gov.au/research-policy/embryo-research-licensing/import-and-export-cell-lines-human-embryo-clones
    45. Australian Border Force (ABF) (2 December 2020) How to Export, ABF, accessed 12 November 2022.
    46. TGA (Therapeutic Goods Administration) (20 January 2020) ‘Export of human substances’ Department of Health and Aged Care, Australian Government. https://www.tga.gov.au/resources/publication/publications/export-human-substances
    47. COSA (n.d.) Regional & Rural Oncology Group, COSA, accessed 12 November 2022.
    48. National Health Act 1953 (cth) https://www.legislation.gov.au/Details/C2022C00198
    49. Health Insurance Act 1973 (cth) https://www.legislation.gov.au/Details/C2022C00174
    50. Freedom of Information Act 1982 (cth) https://www.legislation.gov.au/Series/C2004A02562
    51. European Medicines Agency (March 2023)  Guideline on computerised systems and electronic data in clinical trials (europa.eu), European Medicines Agency.
    52. NHMRC (National Health and Medical Research Council) (n.d.), ‘Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities’ NHMRC, Australian Government.
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