Through the Office for Research, the RMH has implemented Standard Operating Procedures to achieve at least minimum good clinical practice standards in clinical trials and other clinical research.
Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) are based on those developed by our insurer, the Victorian Managed Insurance Authority (VMIA) in 2007, which in turn are based on the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95, an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials). The SOPs are intended to provide the necessary tools to ensure that all research at Melbourne Health is conducted in accordance with ICH/GCP guidelines and applicable legislation and regulations. Compliance with this standard provides public assurance that the rights, safety and well being of research participants are protected and that clinical trial data are credible.
The overarching ICH (International Conference on Harmonisation) GCP guideline (1996) was developed with consideration of good clinical practices of the European Union, Japan and the United States as well as those of Australia, Canada, the Nordic countries and the World Health Organisation. Its objective is to provide a unified standard for the countries involved in its development, and for those countries who adopt its principles, to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Researchers at Melbourne Health should adopt these SOPs as part of their standard research practices and incorporate the SOPs into their departmental procedure manuals for undertaking research involving human participants.
What are Standard Operating Procedures or SOPs?
An 'SOP' is a specific description of how to undertake a particular task. SOPs provide detailed written instructions to achieve uniformity of the performance of a specific function. Where an 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 an 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.