**4. Conclusion and recommendations**

System improvement using this model is unlikely to be achieved without added cost and additional resources for the Sponsors, hospitals and governments. Simplification and streamlining of site accreditation and selection processes, monitoring requirements, ethics, governance and contractual matters are needed to reduce cost and workload, and to expedite approval processes.

#### **4.1. Recommendations**

the expenses related to staff will be covered by existing work contracts and funding mechanisms that exist for routine operations. Remuneration of sites for trial-related activities should equate to the proportion of work the site undertakes and should be negotiated between Sponsor, primary and satellite sites at the outset. Primary sites need to be renumerated for coordination of trial activities and preparation of regulatory documentations across clusters.

Many of the regulatory aspects of clinical trials are governed by local and state jurisdictions and are therefore beyond the scope of this document. It is important to engage with health service executives, ethics committees and research governance officers to expedite approval processes within clusters. However, a simplified and streamlined approach at state and

It is recommended that the primary site takes the responsibility for preparation and submission of documents related to ethics, contracts and site-specific assessment forms (SSAs) in order to streamline and expedite the trial approval processes. Contractual, ethical and governance processes can be expedited when common standards and strong collaboration are

It is prudent for clinicians or cancer centre managers who wish to participate in this model to get the support of their managers and chief executive officers especially in developing trial clusters between centres located within other health service districts and states so that gover-

Primary sites and the Sponsor assume responsibility for ensuring that criteria for safe care are met by all sites within a cluster. When undertaking investigator lead trials, both the primary and satellite are indemnified as per each state and territory health department provision. For industry-sponsored studies the indemnity is provided by the trial Sponsor (https://medicine-

The Sponsor of a clinical trial takes overall responsibility for the conduct of the trial, including

Agreements between sites within a cluster could be in the form of formal contracts, or overarching agreements such as Service Level Agreements (SLA). This matter needs to be solved at the local level between health services or at the state level through research and governance

System improvement using this model is unlikely to be achieved without added cost and additional resources for the Sponsors, hospitals and governments. Simplification and streamlining of site accreditation and selection processes, monitoring requirements, ethics, governance

saustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/).

national level may reduce the cost and expedite the approval processes.

established between primary and satellite sites within clusters.

nance and contract processes can be streamlined.

protocol design and the investigational product.

offices in collaboration with the Sponsors.

**4. Conclusion and recommendations**

**3.15. Indemnity, insurance and clinical trial agreements**

**3.14. Regulatory considerations**

172 Clinical Trials in Vulnerable Populations

