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Clinical Trial Research Agreements
Clinical Trial Research Agreements
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Health Technology Assessment (HTA)（https://www.medicinesaustralia.com.au/policy/health-technology-assessment-hta/）
Access to Medicines Working Group (AMWG)（https://www.medicinesaustralia.com.au/policy/access-to-medicines-working-group-amwg/）
Clinical Trials（https://www.medicinesaustralia.com.au/policy/clinical-trials/） Clinical Trial Research Agreements（https://www.medicinesaustralia.com.au/policy/clinical-trials/clinical-trial-research-agreements/）
Indemnity & Compensation Guidelines（https://www.medicinesaustralia.com.au/policy/clinical-trials/indemnity-compensation-guidelines/）
Research & Development Taskforce (RDTF)（https://www.medicinesaustralia.com.au/policy/clinical-trials/research-development-task-force-rdtf/）
Teletrials（https://www.medicinesaustralia.com.au/policy/clinical-trials/tele-trials/）
Oncology Industry Taskforce（https://www.medicinesaustralia.com.au/policy/oncology-industry-taskforce/） Addressing the challenges of access to new cancer medications（https://www.medicinesaustralia.com.au/policy/oncology-industry-taskforce/addressing-the-challenges-of-access-to-new-cancer-medications/）
About the OIT（https://www.medicinesaustralia.com.au/policy/oncology-industry-taskforce/about-the-oit/）
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Pharma Australia Inclusion Group (PAIG)（https://www.medicinesaustralia.com.au/policy/pharma-australia-inclusion-group-paig/）
Policy Submissions（https://www.medicinesaustralia.com.au/policy/submissions/）
Regenerative Medicines Consortium Programme（https://www.medicinesaustralia.com.au/policy/regenerative-medicines-consortium-programme/）
The panel reviewing Australian clinical trial agreements (previously known as SEBS) is now a national panel known as the National Clinical Trial Agreement (NaCTA) Panel. The NaCTA Panel is comprised of representatives from all states and territories.
Together with Medicines Australia the NaCTA panel have developed five Clinical Trial Research Agreements (CTRAs) as listed below, that are available for use by any sponsor and/or institution for specific clinical trial scenarios.
The NaCTA Panel has also developed standard Clinical Investigation Research Agreement (CIRA) templates with the Medical Technology Association of Australia (MTAA), available here（https://www.mtaa.org.au/clinical-investigation-research-agreements）.
Clinical Trial Research Agreement – Medicines Australia Standard Form（https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2021/08/Clinical-Trial-Research-Agreement-Medicines-Australia-Standard-Form-8-March-2017-b-2.doc）
Clinical Trial Research Agreement – CTRA: Contract Research Organisation acting as the Local Sponsor（https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2021/08/Clinical-Trial-Research-Agreement-Contract-Research-Organisation-acting-as-the-Local-Sponsor-8-March-2017-b.doc）
Clinical Trial Research Agreement – Collaborative or Cooperative Research Group (CRG) Studies（https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2021/11/Clinical-Trial-Research-Agreement-Collaborative-or-Research-Group-CRG-Studies-8-March-2017-a.docx）
Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines)（https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2020/11/Clinical-Trial-Research-Agreement-Phase-4-Clinical-Trial-Medicines-8-March-2017-a.doc）
Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines) Contract Research Organisation acting as the Local Sponsor（https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2020/11/Clinical-Trial-Research-Agreement-Phase-4-Clinical-Trial-Medicines-CRO-acting-as-Local-Sponsor-8-March-2017-a.doc）
*Note : Please ensure you are using the most current version of documents found on this page. The most recent version of the Clinical Trial Research Agreement – Medicines Australia Standard Form, was updated in 2017 and should have the title “Clinical-Trial-Research-Agreement-Medicines-Australia-Standard-Form-8-March-2017-b-2”. Schedule 3.3 (1) and (8) should have the words “his or herself” replaced with “themselves/their”; and 4.10 where the text has been changed to “…written approval of the Sponsor.” Using out-of-date forms may cause delays in executing CTRAs.
*Note for Tasmania: The Tasmanian Department of Health and the Tasmanian Health Service are bound to follow Treasurer’s Instruction, Contracts – Disclosure and Confidentiality in Government Contracting , issued under the Financial Management Act 2016 (Tas) (“TI C-1”). Tasmanian CTRAs must have amendments inserted into Schedule 7 or Schedule 4 ‘Special Conditions’ as appropriate, to provide clarity and ensure full compliance with “TI C-1”. For more information, to discuss NaCTA approvals prior to Tasmania joining NaCTA/SEBS or for Tasmanian approved CTRAs please see www.dhhs.tas.gov.au/research（http://secure-web.cisco.com/1cAvyn6lMTVPhSF3BpDu2vI5OX5lZeQHSQirqweSjR24rPaUtZ2CPIKlhZVWpO4SaHWdNUmpaR4UvPHXgJoGQyLw4jWhLkPgRutwXCkWVlEu3FxRjjy2JMx9H-jEe_u-SBsBjEhkIBiKiC_8vCIDq1DQI6YkZPqvpQdoR2FPZMrp-sM3Hwl-EocL7c7V48aY4JixzqRDJ0Iwv22pA0nxqJK8dirWMEwd7j3Gz8iVnx7Mt__0009OivaNBsj4XfQupWN0x9nDZ4EmbKst8j_8Hid2i-GGdDyEhCierFUn187VvxmfhQE7GADiHs9rEvvFEULpQU1d5w1aZn8lteFhUv8Ajixnfub2Gy8jOwxUpoYL1_Vd_KiySDZwM1lz5TZmhFrhhD7_XDnBQ-N6E5PM4fTy4IRiEOOKO2VRT3yAyr0ePOuwE17clFA8fHLNuj1DQo_iSTFfNIavJ9Yz80xQ9GadnAnMrGkWIHEnV4DBkJzaYeM3YhS8nX16hVx_T1Y85/http%3A%2F%2Fwww.dhhs.tas.gov.au%2Fresearch）
*Note for the Northern Territory: The Northern Territory of Australia through its agency the Department of Health, is required to comply with the Northern Territory Treasurer’s Direction (TD)（https://aus01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftreasury.nt.gov.au%2Fdtf%2Ffinancial-management-group%2Ftreasurers-directions&data=05%7C02%7CConstantine.Tablan%40medicinesaustralia.com.au%7C2e31415d580c40ff7e0308dd463e7875%7C6d1d31e94e5e4504a9bfa11070f76971%7C0%7C0%7C638743956326655807%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=r%2B5yI%2FYv1A8nYyhL79IpUc3tG5exq3LYvgtQZPSr%2FyQ%3D&reserved=0） in respect of insurance arrangements. Approved Northern Territory CTRAs must include specific amendments in Schedule 4 ‘Special Conditions’, as appropriate, to provide clarity and ensure full compliance with this TD. For more information on the amendments or to obtain a Northern Territory approved CTRA version please see https://health.nt.gov.au/data-and-research/nt-health-research/research-governance（https://aus01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhealth.nt.gov.au%2Fdata-and-research%2Fnt-health-research%2Fresearch-governance&data=05%7C02%7CConstantine.Tablan%40medicinesaustralia.com.au%7C2e31415d580c40ff7e0308dd463e7875%7C6d1d31e94e5e4504a9bfa11070f76971%7C0%7C0%7C638743956326671061%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Te4JsgudLQZ7K4Ju9iJkjRDLd5nl2FQHOly%2F4HMaMPY%3D&reserved=0）
Teletrials Subcontract
This subcontract is designed to complement the Clinical Trial Research Agreement – Medicines Australia Standard Form, which would form the Head Agreement when a study is conducted under a Teletrials model. The Subcontract is entered into between the Institution (as named in both the CTRA and the Subcontract) (also known as Primary Teletrials site) and the Subcontractor (that is, the Teletrials satellite site).
Any amendments proposed by either party to the Teletrials subcontract are to be negotiated between the parties.