Medicines Australia Clinical Trial Agreement

“Organisations participating in a joint research project should ensure that an agreement is reached with the partners on the management of the research. Such an agreement should follow the general principles of this Code, including integrity, honesty and the duty of excellence. The Group Collaboration Agreement is designed for individual research collaborations between two or more parts of the Melbourne Academic Centre for Health Group from time to time. This proposal for a Research Collaboration Agreement is assumed that there is no specific part of the research cooperation for which it is used. It houses the parties that make available “materials” for research cooperation and for small to medium amounts spent by the parties. However, if more complex cooperation is proposed, in particular those concerning the commercialization of intellectual property or the financing conditions of per capita financing agreements, it is likely that a more detailed and tailor-made cooperation agreement will be more appropriate and that the parties should involve their respective legal advisers in the assistance. For more information, please refer to the MACH guidelines. Fill out the right agreement relevant to your study. The agreement may take several forms, including a legal contract signed by the Chief Executive Officer, an exchange of letters or a research management plan signed by all parties, or management plans signed by appropriate representatives of all parties.

“Clinical Trial Notifications (CTN) must be completed and submitted electronically by the study sponsor to the Therapeutic Goods Administration (TGA). For more information on eCTN forms, click here. All commercially sponsored clinical studies must use Medicines Australia`s standard research agreements: if you opt for a non-standard agreement or are commissioned by a third party who wishes to use a non-standard agreement, legal verification is required. Research Ethics & Governance (REG) may arrange this on your behalf by collaborating with legal advisors for MCRI and/or RCH. However, it is highly recommended to use a standard chord. A formal research agreement is a requirement of the Australian Code for Research Responsibility (2007). It states that all commercially supported clinical trials of MCRI and/or RCH must be implemented by medicines Australia Standard Form of Indemnity (MCRI/RCH Standard Wording). This form has been adapted to reflect the fact that MCRI is now part of the campus, not RCH. There are a number of different types of agreements. The agreement you need to use depends: NHMRC-funded research, which involves cooperation between two or more sites, must have a Multi-Institutional Agreement (MIA). The MIA is a model NHMRC agreement that describes how NHMRC funds are disbursed to the parties during the funding period and contains details about the managing entity, intellectual property, publication rights, insurance and indemnity obligations, etc.

Please contact the MCRI Grants Office for more information about MIA`s and NHMRC Grant Funded Research….

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