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