Governance
Research Governance
Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or approve to be conducted.
The Southern Health Research Directorate provides governance across all Southern Health campuses including, Prince Henrys Institute, Southern Clinical School, Monash Institute of Medical Research and the Deakin - Southern Health Nursing Research Centre.
A number of developments have recently been introduced at a national and international level incorporating new standards to ensure research activities are conducted in accordance with sound research governance practices. These requirements are set out in:
- the NHMRC National Statement on Ethical Conduct in Human Research (2007)
- the Australian Code for the Responsible Conduct of Research (2007)
- the Victorian Managed Insurance Authority guidelines
- the Australian Council on Healthcare Standards.
All researchers at Southern Health must strive to conduct research in the manner indicated in the Southern Health Human Research Policy.
Auditing of Research Projects
The Southern Health Human Research Ethics Committees (HREC) are required to monitor all approved research in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007).
It is recommended that researchers audit their own project procedures for compliance annually using the Research Governance Self Auditing tool and it is recommended that this occur simultaneously when completing the Annual Project Report Form (Form 13).
Projects may be selected for auditing by the Research Directorate for a variety of reasons:
- Human Research Ethics Committee review – following approval of a new protocol; as part of the approval process; or due to the classification of risk.
- Random selection.
- A complaint.
- Annual report and/or Research Governance Auditing Tool return verification.
Auditing documents
Standard Operating Procedures to achieve Good Clinical Practice
The Southern Health Research Directorate has put in place Standard Operating Procedures (SOPs) to achieve good clinical practice (GCP) in clinical research. The aim of the SOPs is to provide the necessary tools to ensure that researchers at Southern Health are able to operate to International Clinical Harmonisation/Good Clinical Practice Guidelines (ICH GCP) standards by efficiently providing operating documentation.
What are Standard Operating Procedures?
A ‘SOP’ is a specific description of how to undertake a particular task. Where a SOP is in place it is expected that procedure would be followed as described by all of the relevant people referred to within the procedure. If a SOP is not followed this would be seen as a breach of process from the point of view of an audit or from a legal perspective.
All SOP documents are available on the PROMPT system on the Southern Health Intranet.
Documents are also available to download below:
- Documentation of Investigational site Qualifications, Adequacy of Resources and Training Records Procedure (VMIA GCP 001)
- The Study Site Master File and Essential Documents Procedure(VMIA GCP 002)
- Communication with HREC, Trial Sponsor and Insurer Procedure(VMIA GCP 003)
- Protocol and Investigational Brochure Content, Design, Amendments & Compliance Procedure(VMIA GCP 004)
- Receipt and Handling of Investigational Product Procedure(VMIA GCP 005)
- Informed Consent procedures and writing Patient Informed Consent forms Procedure(VMIA GCP 006)
- Case Report forms, Source Documents, Record keeping and Archiving Procedure(VMIA GCP 007)
- Site Initiation and Close-out Procedure(VMIA GCP 008)
- TGA Notification and SAE Reporting Requirements Procedure(VMIA GCP 009)
- Investigator Responsibilities Procedure (VMIA GCP 010)
- Sponsor Responsibilities & Investigator initiated studies Procedure(VMIA GCP 011)
- Handling & Shipping of Infectious Substances for Clinical Trials Procedure(VMIA GCP 012)
- Complaint Resolution Procedure
- Handling of Research Misconduct and Resolving Allegations Procedure
- Management of Research Data and Records Procedure
- Peer Review Procedure
- Research Governance Procedure
- Supervision of Research Trainees Procedure
- Collaborative Research Across Institutions Procedure
- HREC Approval Process Procedure
- Monitoring and Auditing of Research Procedure
- Privacy and Confidentiality in Research Procedure
- Research Risk Management Procedure
- Use of Human Tissue in Research Procedure
Document Downloads
- Clinical Trial Event Reporting Algorithm for Sponsors
- Conflict of Interest - Background
- Conflict of Interest - Declaration
- Conflict of Interest - Policy
- Conflict of Interest - Procedure
- Databank Access Request for Research Purposes
- Delegation Log
- Establishment of Databank checklist
- Guidelines for Auditing of Research
- ICAO Technical Instructions for packaging of exempt human or animal specimens
- Induction, Training and Accreditation checklist tool
- Investigational Product Accountability Record
- New Research Team Checklist tool
- New Researcher Checklist tool
- Protocol and IB templates
- Reporting Requirements for Clinical Trials conducted under the CTN and CTX schemes
- Self Audit Tool
- Short Audit Template
- Site Initiation and Close-out checklists
- Site Initiation and Close-out procedure
- Study site master file and essential documents templates
- TGA Notification and SAE Reporting Requirements.docx
- Use of Cadaveric Tissue for Research
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