Clinical Trial Agreement Medicines Australia

There are a number of different types of agreements. The agreement you must use depends on it: if you opt for a non-standard agreement or if you 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. This can be used to cover the start-up fee and must be signed before or during the ethics review before the main agreement is signed. For clinical, public health and non-clinical projects, which: Clinical Trial Notifications (CTN) must now be finalized and transmitted electronically to the Therapeutic Goods Administration (TGA) by the study sponsor. For more information on eCTN forms, click here. 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 agreement should be written down. It must cover intellectual property, confidentiality and copyright issues; sharing business revenues, ethical responsibility and security clearance; and reports to the relevant authorities.

It should look at the protocols that partners should follow for the dissemination of research results as well as for the management of primary research materials and research data. All commercially sponsored clinical studies must use Medicines Australia`s standard research agreements: the RCH and MCRI have a legal agreement that makes MCRI responsible for all clinical trials on campus. As a custodian of research, the MCRI should be mentioned as a party (institution) in all agreements; and if recruitment is done through the RCH, RCH should be listed as a site (schedule 1). The following information should therefore be used: “Organizations participating in a joint research project should ensure that an agreement is reached with partners on research management.

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