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. 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. If this information is not disclosed, the review and approval of the agreements is delayed. 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. All clinical trials that are commercially sponsored, the standard research agreements of Medicines Australia: The Medicines Australia CTRAs, in accordance with the TGA Regulation, must require that the sponsor of a study be an Australian corporation. 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 wording is here: there are a number of regulatory documents required for 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. 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). As such, the following information should be used: For clinical, public and non-clinical research projects, clinical clinical clinical clinical notifications (NTCs) should now be finalized and transmitted electronically to the Therapeutic Goods Administration (TGA) by the study sponsor. For more information on eCTN forms, click here.