Medicines Australia Clinical Trials Agreement

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: There are a number of types of agreements. The agreement you must use depends on it: it can be used to cover the start-up fee and must be signed before or during the ethics review before the execution of the main agreement. NHMRC-funded research, which includes cooperation between two or more sites, must have a multi-institutional agreement (MIA). The MIA is an NHMRC presentation agreement that describes how NHMRC funds will be paid to the parties during the funding period, specifying who is the management institution, intellectual property, publication rights, insurance and compensation obligations, etc. For more information on MIA`s and NHMRC Grant funded research, please contact the MCRI Grants Office. If this information is not disclosed, the review and approval of the agreements is delayed. The agreement can take many forms, including a law contract signed by the Chief Executive Officer, an exchange of letters or a research management plan signed by all parties, or a management plan signed by all parties. For all commercially sponsored examinations, an insurance certificate must be presented to accompany the award. Please note that the insurance certificate must be placed on the insurer`s header and not on a broker`s header. On this page, you`ll find links to a series of standard search agreements and instructions on which agreement should be used and in which situations. For any research cooperation, there is only one agreement to be reached, i.e.

there is no need to use a Clinical Research Agreement (CTRA) and a Material Transfer Agreement (MTA), as the issues dealt with in the MTA are covered by the broader CTRA. For all commercially sponsored and conducted clinical trials on MCRI and/or RCH, MCRI/RCH Standard Wording (MCRI/RCH Standard Wording) must be used. This form has been adapted to reflect that MCRI is now the campus contract partner – not RCH. 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. This type of research should be carried out as part of MCRI, and researchers should hold an MCRI appointment – please contact MCRI HR for more information. All agreements must be verified by MCRI Legal before being passed on to your researchers. These agreements must be signed by James Dromey, MCRI Chief Operating Officer and MCRI Legal. Reg will organize signatures on behalf of the researchers. 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.