Clinical Study Notifications (CTNs) must now be finalized by the study sponsor and sent electronically to the Therapeutic Goods Administration (TGA). For more information on eCTN forms, click here. There are a number of regulatory documents that are required in a research project, including agreements, insurance and compensation. If you need further explanation of when these documents are needed or if you need an appropriate signatory, please consult the process map for regulatory documents or the crdo website for more information. A formal research agreement is a requirement of the Australian Code for Responsible Research Conduct (2007). It says that all commercially assisted trials must be subject to an insurance certificate as compensation. Please note that the insurance certificate must be placed on the insurer`s header and not on a broker`s header. The MACH Group Research Collaboration Agreement model is designed from time to time for research cooperation between two or more parts of the Melbourne Academic Centre for Health (MACH). This research collaboration agreement assumes that there is no specific leadership or coordination in the research cooperation for which it is used. It accepts parties that provide “materials” for research cooperation and devote small to medium resources for the parties. However, if more complex cooperation is proposed, such as those relating to the commercialization of intellectual property or financing conditions, a more detailed and appropriate cooperation agreement is likely to be more appropriate and the parties should involve their respective legal advisors to support them.
More information can be found in the MACH guidelines. If you opt for a non-standard agreement or are activated by a third party who wishes to use a non-standard agreement, a legal check is required. Research Ethics – Governance (REG) can arrange this on your behalf by contacting MCRI and/or RCH legal advisors. However, it is highly recommended to use a standard chord. For clinical health, public health and non-clinical research projects that: Australia CTRAs Drugs, in accordance with TGA Regulations, require the proponent of a study to be an Australian legal entity. In order to minimize legal risk on behalf of its institutions, the SEBS Committee`s policy is to accept only Australian corporations as contracting parties in a CTRA they have negotiated. It also implies that no proposal to amend the CTRA CRO to include the international organization as the main part of the contract in a tripartite agreement is accepted. The SEBS Committee approved a standard formulation for extending third-party rights to international organisations.
The agreed text is available here: This can be used to cover the start-up tax and should be signed before or during the ethics review before the execution of the main agreement. “Organizations involved in a joint research project should ensure that agreement is reached with partners on research management. Such an agreement should follow the general principles of this code, including integrity, honesty and a commitment to excellence. For all commercially sponsored and conducted clinical trials on MCRI and/or RCH, MCRI/RCH Standard Wording (MCRI/RCH Standard Wording) must be used.