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Category
Standard
Standard
National Clinical Trials Governance Framework
Version
Edition 1
Access
Open
Status
Active
Created
February 2022
The National Clinical Trials Governance Framework supports the integration of clinical trial services into routine hospital care. It strengthens governance arrangements for clinical trial services and provides clarity to governments, health service organisations, hospital administrators, clinicians and others responsible for delivering clinical trials.

The Framework sets out roles and functions, mandatory actions required for accreditation, suggested strategies for the actions, and examples of evidence demonstrating the actions.

The Framework is underpinned by best practice principles consistent with Australian regulations, and aligns with National Safety and Quality Health Service Standards.

Main sections:

• Health service organisational governance

• Clinical trials governance as an integrated component of organisational governance

• Components of the National Clinical Trials Governance Framework

• Accreditation to the NSQHS Standards

• Core principles of governance for clinical trial services

• Roles and functions of identified positions

• Clinical Governance Standard

• Component 1: Governance, leadership and culture

• Component 2: Patient safety and quality improvement systems

• Component 3: Clinical performance and effectiveness

• Component 4: Safe environment for the delivery of care

• Component 5: Partnering with consumers
Access The National Clinical Trials Governance Framework and user guide for health service organisations conducting clinical trials, Edition 1

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