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Barwon Health Clinical Trial Unit achieves highest TGA compliance

Thursday, 13 January 2022

 

The Barwon Health Clinical Trial Unit went under the microscope in November as they undertook a Good Clinical Practice inspection by the Therapeutic Goods Administration (TGA), Australia’s regulator of therapeutic goods including prescription medicines, vaccines and medical devices.Bree Sarah photo cropped for news

The Good Clinical Practice inspection comprised three days of detailed interviews with clinical trial study team members, as well as visits to Barwon Health clinical trial, laboratory and pharmacy facilities, and in-depth scrutiny of research records, practices, ethics and governance to ensure that trial protocols are followed and that participant safety and rights are protected.

Barwon Health is delighted to announce that the Clinical Trial Unit attained a compliance grading of C1: Good Compliance for the inspection, being the TGA’s highest grade of compliance.

Congratulations to Unit Leaders Prof Mark Kotowicz and Prof Eugene Athan, Unit Manager Bree Sarah (pictured), and Unit Nurses Kate Ellis, Jo Chambers, Fahriya Zandari, Anne Welsh and the clinical trial pharmacy team for this impressive achievement.

To find out more about clinical trials at Barwon Health, please click here.

To participate in a clinical trial at Barwon Health, please click here.