To help the Office of Research Grants and Contracts prepare the Clinical Trials Research Agreement, complete this notification form and offer form and send it to the office. If necessary, the Risk-Legal Research Scholarships and Contracts Office may benefit from specific advice regarding these agreements (including the establishment of special conditions) or for the review of third-party agreements. Risk – Legal requires the completion of this communication to provide advice. Clinical studies include the collection, use or disclosure of personal and sensitive information (sometimes all three) or access to personal or sensitive information held by third parties (e.g. B Medicare, a family doctor`s office or a public hospital). „Sensitive information“ includes, among other things, medical information and information about racial or ethnic origin or a person`s sexual orientation or practices. In accordance with the G-CTHandbook, the TGA has adopted a risk-based approach to the governance of clinical trials in Australia. The ECs, which are responsible for approving the experimental protocol under the CTN and CTX systems, enjoy a high degree of independence and are responsible for defining their own procedures for receiving and reviewing research proposals. In addition, the EC and the institution must determine what information to provide in support of an application and how the application will be considered by the committee. The EC should request additional information which it deems necessary to review the proposed research. Some clinical studies may be subject to specific rules. Example: G-SafetyDataMgt indicates that other situations requiring expedited notification may contain information that may have a significant impact on the assessment of the benefit-risk ratio of a trial product or that would be sufficient to account for changes in the administration or conduct of a clinical study.
The conduct of clinical trials is also governed by other national laws and guidelines, which are discussed below. While each EC has its own necessary submission procedures, AUS-46 indicates that the National Health and Medical Research Council (NHMRC) has developed the Humanities Application (HREA) to submit proposals for human research on ECs (AUS-9). The HREA is an online tool designed to ensure the national consistency of information transmitted for ethical audit. Jurisdictions participating in the national mutual acceptance system (NMA) are required to use HREA. According to the G-CT manual, study sponsors and researchers should use HREA unless otherwise stated. AUS-19 contains resources for the use of HREA. For more information on NMA, see below. Skills have been developed to involve better-trained staff in the conduct and follow-up of clinical trials. For more information: AU-ICH GCPs and G-NatlStmt state that the research participant and/or his or her legal representatives or legal guardians should provide contact information to the person responsible for reviewing the application for proceedings and/or their rights. AUS-45 guides the participant and/or their legal representatives or guardians with information on who they can contact about a clinical trial application – Option 1 is the examiner, Option 2 is the Ethics Committee (which is known in Australia as the Human Research Ethics Committee), Option 3 is the institution and Option 4 is the institution for health complaints in the state or territory. Early and thorough planning is essential for the rapid and effective start-up of clinical trials.
In developing the national best practice process for site evaluation and approval of the governance phases of good practice, NHMRC has shown that significant improvements can be made to the start-up phases of clinical trials if sponsors, investigators and clinical trial sites communicate effectively and if an appropriate feasibility assessment is made prior to the presentation of ethics and location approvals.