Prior to the commencement of the study, as set out in the UA-ICH PCMs, the sponsor must sign an agreement between all relevant parties, including the EC, Qualified Investigators (IQs), Contract Research Organizations and others, to ensure full compliance with regulatory requirements. On 24 March 2020, the Australian Ministries of Health and Areas, the TGA, the National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG) published: COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors. The guide addresses the ongoing management of ongoing clinical trials and the processes for reviewing and approving new clinical trials, and will be reviewed and updated as the situation evolves. THE UA-ICH PCGs characterize vulnerable populations as those who may be overly influenced by expectations, whether justified or not, by the benefits associated with participation in a clinical trial, or by a retaliatory response for non-participation. Examples include members of a hierarchical group such as medical, pharmacy, dental and nursing students, subordinate staff in hospitals and laboratories, employees of the pharmaceutical industry, members of the armed forces, and imprisoned persons. Other people at risk are patients with incurable diseases, residents of nursing homes, the unemployed or poor, patients in emergency situations, the homeless, nomads, refugees, minors and people unable to give consent. According to G-NatlStmt, people who may be involved in illegal activities are Aboriginal and Torres Strait Islander people, ethnic minorities and people from other countries are other groups for whom specific ethical considerations are required. According to AUS-47, the application process for the CTX program is currently being reviewed by the TGA. Those with questions about the CTX program are asked to contact the TGA directly at firstname.lastname@example.org. Public health agencies are required to conduct an SSA to assess whether the site has the capacity to conduct the research (for example. B, physical resources, personnel and insurance). The researcher submits the SSS to the institution`s Research Governance Officer (GERD).
Research projects cannot begin until the researcher has received approval from the institution`s GERD. SSS and EC examinations may take place in parallel, although some aspects of SSS must take place after the EC examination. AUS-43 further states that all SSA applications must be submitted to the GERD within each public health organization using the SSA form for that state or territory. Clinical trials in public health organisations in South Australia must use the online SSA form in AUS-37. AUS-8 is used to complete SSA forms at Mater Health, Queensland and Victoria. In accordance with G-NatlStmt, the informed consent requirements for the conduct of clinical trials follow the general requirements listed in the Declaration of Consent section, sub-topic Required Elements. However, with the exception of cases of advanced therapeutic therapy, the process of providing information and obtaining consent to participate in research should be clearly separated from clinical care when the woman is pregnant and the fetus is in utero. Under the TGR, the sponsor must provide written assurance to comply with all requests related to the study of an authorized meP agent, including approval to inspect clinical trial sites. .