• Guidelines for Auditing of Research 
• Self Audit Tool
• Short Audit Tool

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.

Standard Operating Procedure documents

• Guidelines for Standard Operating Procedures
• SOP1: Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records
• SOP2: Study Site Master File and Essential Documents
• SOP3: Communication with HREC, Trial Sponsor and Insurer
• SOP4: Protocol and Investigational Brochure Content, Design, Amendments & Compliance
• SOP5: Receipt and Handling of Investigational Product
• SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms
• SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving
• SOP8: Site Initiation and Close-Out
• SOP9: TGA Notification and SAE Reporting Requirements
• SOP10: Investigator Responsibilities
• SOP11: Sponsor Responsibilities in Investigator Initiated Studies
• SOP12: Handling and Shipping of Infectious Substances for Clinical Trials

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.