Research Governance Policy Directive
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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:
In conjunction with The National Statement, the SALHN Office for Research 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 SALHN Office for Research, the below roles have been established to manage concerns or complaints submitted about potential breaches of the Code:
At SALHN all approved studies will be monitored by the Office for Research via the below channels:
All templates and guidelines can be found on the Office for Research Post Approval page.
Projects are selected for monitoring for a variety of reasons such as:
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 a letter from the SALHN Office for Research advising which study or studies are being audited and the date of the visit.
Applications submitted to the Southern Adelaide Clinical Human Research Ethics Committee will 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).
As part of the Office for Research 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), the SALHN Research Integrity Officer 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.
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 Office for Research if they prefer.
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. Self-audit tools/templates can be found here (DOC 33KB).
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.
Access this document here (PDF 2049KB).
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.
A template can be found here.
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.
A delegation log template can be found here (DOCX 33KB).