Framework putting clinical trial governance in the picture

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ARCS Australia has welcomed the release of the National Clinical Trials Governance Framework by the Australian Commission on Safety and Quality in Health Care (the Commission).

The framework will be piloted from March to May 2020 and the Commission is seeking expressions of interest for the pilot by 13 March.

ARCS said the framework describes the actions that are essential for health service organisations to achieve integrated corporate and clinical governance systems for clinical trial service delivery. The framework has been developed based on national consultation.

According to Dr Shanny Dyer, CEO of ARCS Australia, “The framework is the most significant change to how clinical trials are delivered in Australia since the introduction of the Clinical Trial Notification scheme.

“The aim of the framework is to support better safety and quality to improve health outcomes for patient and trial participants. It sets out everyone’s mandatory responsibilities and accountabilities and assures that the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving.

“ARCS Australia has supported the sector by providing high quality accredited training on international standards and GCP as well as specific training on all aspects of conducting clinical trials. We will develop specific training linked to the framework to ensure appropriate application and guidance around the standard as the framework is embedded,” added Dr Dyer.