All staff have a role to play in creating a safe and high-quality healthcare system when undertaking clinical trials or research at SALHN. They are responsible and accountable for their patients/participants safety, minimising risks to consumers and for continuously monitoring and improving the quality of the care provided.

An online ’Introduction to Safety and Quality’ learning module has been developed to inform staff on how this relates to them.

Implementation of the National Clinical  Trials Governance Framework

Research Governance

Research Governance at SALHN is driven by the SA Health Research Governance Policy Directive which outlines the requirements applicable to research being undertaken at an SA Health institution. Our main aim is to foster high quality, accountable and responsible research that is compliant with all local and national policies standards and guidelines.

All research proposals need to be submitted to the Research Governance Officer (RGO) via a Site-Specific Application (SSA) form. The RGO will review the application to ensure it meets all legislative, financial, safety and quality standards. Once the RGO is satisfied that all of the necessary requirements have been met, a briefing is sent to the SALHN CEO for final authorisation.

Clinical Governance

The SALHN Quality Plan 2022-24 was endorsed by the SALHN Board in May 2022. This sets out the direction and key activities to strengthen safety and quality systems for 2022. Our plan for Clinical Trials is to further improve the safety and quality of the clinical services provided to our consumers and their families.

Introducing new clinical practice at SALHN

Research and Quality improvement activities support SALHN to:

  • Make informed decisions on the clinical effectiveness and safety of our interventions
  • Ensure our interventions serve the population
  • Deliver best and evidenced based practice and high standards of care
  • Ensure transparency around responsibility and accountability for our standards

As per The National Statement 5.5.1, each institution has the ultimate responsibility for ensuring, via its research governance arrangements, that all its approved research is monitored.

Monitoring research is important, as it:

  • enhances the safety of patients and staff participating in research
  • protects human participants' rights and well-being and ensures that research data is high quality
  • encourages transparency and provides research oversight
  • promotes good research practice
  • mitigates institutional sponsorship risks or participation in investigator-initiated research studies and clinical trials.

In conjunction with The National Statement, the SALHN Research Hub use the Australian Code for the Responsible Conduct of Research (2018) - Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018).

Maintaining high research standards is the responsibility of all Australian research institutions, researchers and funding agencies. This Guide sets out a model for managing and investigating potential breaches of the Code.

Institutions that conduct research and train and employ researchers have primary responsibility for the prevention, detection, investigation and resolution of complaints about the conduct of that research.

Within the Research Hub, the below roles have been established to manage concerns or complaints submitted about potential breaches of the Code:

  • Research Integrity Advisor (RIA) / Ethics Officer: Persons with knowledge of the Code and institutional processes nominated by an institution to promote the responsible conduct of research and provide advice to those with concerns or complaints about potential breaches of the Code.
  • Assessment Officer (AO) / Research Governance Officer - A person or persons appointed by an institution to conduct a preliminary assessment of a complaint about research.
  • Designated Officer (DO) / Manager, SALHN Research Hub - A senior professional or academic institutional officer or officers appointed to receive complaints about the conduct of research or potential breaches of the Code and to oversee their management and investigation where required.

At SALHN all approved studies will be monitored by the Research Hub via the below channels:

  • Annual report and (where applicable) safety report
  • Desk top audit
  • Risk register
  • Interviews with researchers and
  • Participant feedback
  • Providing templates for researchers to self-monitor

Annual reports / safety report

All templates and guidelines can be found on the Research Hub Post Approval page.

Progress reports

Progress reports must be submitted annually on the ethics approval date stated on the approval letter. Failure to submit the report will result in the ethics approval being suspended until the report is provided.

Final reports are submitted upon completion of the project, which is defined as the time point where all participants have completed any study related activity and all access to medical records has ceased.

All templates and guidelines can be found on the Research Hub Post Approval page.

Desk top audits/site visits

Projects are selected for monitoring for a variety of reasons such as:

  • study protocol change
  • the classification of risk
  • random selection
  • a complaint
  • annual report verification.

Audits and site visits are not designed to find fault, but rather to assist our researchers in reviewing how the research is conducted, and to detect, correct and prevent potential and existing problems. It is also an opportunity to assist our researchers in ensuring they have the tools to achieve the above.

If your research is selected for a desk top audit, you will receive an email advising which study is being audited with an attached audit form to complete.

If your research is selected for a site visit, you will receive an email from the SALHN Research Hub advising which study or studies are being audited and the date of the visit.

Risk register

Applications submitted to the Southern Adelaide Clinical Human Research Ethics Committee may need to include in the protocol a safety monitoring plan via a Risk Register.

Risk registers are an important document, that enables the study risks to be identified, managed and tracked.

Please see the Risk Register template (XLSX 23KB).

Interviews with researchers

As part of the Research Hub's ongoing commitment to high quality research, we conduct interviews with researchers and research participants.

Upon submission of a final report (see SALHN Research website for template), a member of the Research Hub will ask if the researcher would like to take part in an interview about their research. The conversation will be around what worked, what didn’t work, areas for improvement, successes and what they would change on reflection. The results will be de-identified and used for quality improvement purposes.

Participant feedback

Participants are invited to provide their feedback via an anonymous survey. Posters are positioned around the hospital, with a QR code that links to the survey. Participants are also invited to contact the Research Hub if they prefer.

Researcher Self-Monitoring Templates

Researchers should continually monitor their own research and implement tools to ensure adherence to the approved protocol by creating Standard Operating Procedures, keeping an up to date delegation log and conducting self-audits. A Self Audit Tool has been designed to help researchers review their current research project/s at any time to ensure the research is still compliant with the HREC approved protocol, the National Statement, Good Clinical Practice and the Australian Code for Responsible Research. Visit Self audit for researchers (DOC 33KB).

Standard Operating Procedures (SOPs)

National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia — Based on the International Council for Harmonisation Guideline for Good clinical practice.

These National Standard Operating Procedures for Clinical Trials, including Teletrials have been developed to assist organisations engaged in conducting clinical trials in Australia to, wherever possible, standardise their procedures for key operations related to clinical trials and specifically teletrials. They have been developed for the National Mutual Acceptance (NMA) Scheme in Australia and to support a consistent approach to national implementation more broadly.

Standard operating procedures (SOPs) are important documents within all types of research, that provide researchers and their team with a useful tool to clearly outline the process for completing common tasks and procedures.  SOPs set expectations on how the tasks are to be completed to ensure consistency of the task delivery.

This document will outline the purpose of the SOP, who is responsible for the task/s, the procedures, any contingency plans or corrective actions if the SOP cannot be followed and any supporting documents.

View the Standard Operating Procedure Template.

Delegation log

The responsibilities of the site Principal Investigator (PI) are outlined in the approved protocol and in the Guide for Good Clinical Practice (GCP). The principal investigator may delegate some of their responsibilities to other members of the study team.

In accordance with ICH GCP E6 Guideline Sections 4.1.5, and 8.3.24 a Signature and Delegation of Duties log must be maintained at the site to demonstrate which tasks have been delegated and to whom and capture the signature and initials of the PI and all staff.

The log must be updated regularly to document changes in staff responsibilities throughout the study.

View Delegation Log Template (DOCX 33KB).