The National Clinical Trial Governance Framework (NCTGF) outlines the actions that are vital for the attainment of integrated corporate and clinical governance systems for clinical trial service delivery by health service organisations. This framework supports the integration of clinical trial service provision into routine hospital care for improved patient outcomes.
The purpose of this framework is to ensure that clinical trials are conducted in a safe environment and in a high-quality manner for improved health outcomes for patients and the community.
It is anticipated that, embedding clinical trial services into routine practices of health service organisations under the NSQHS Standards will deliver measurable operational efficiencies across multiple therapeutic areas delivering clinical trial services, including:
- Pre-trial assessment of a trial site (trial site selection, feasibility assessment)
- Pre-recruitment activities (ethical and local site specific assessment review and approval time frames)
- Recruitment activities and trial management
- Workforce training and engagement
- Trial related business and financial management.
The 5 components of the NCTGF are:
Roles and Functions of each position within the Health Service Organisation can be found on this website - https://www.safetyandquality.gov.au/standards/national-clinical-trials-governance-framework/resources-national-clinical-trials-governance-framework
To comply with the NCTGF Standards, each department that conducts interventional trials will need to provide evidence for compliance of each action point items as outlined in the NCTGF User Guide. The Research Directorate has developed the NCTGF Departmental Checklist to help each Clinical Trial Unit to conduct self-assessment and demonstrate departmental conformance of the Framework. The first departmental checklist will be due in early May 2023. It will be subsequently due every six months to ensure up-to-date information and continuous improvement progress towards the full conformance of the Framework.
The Checklist will be completed and responses will be stored digitally on SAGE.
The items of each section mapped to the action points for the Framework Accreditation. The main sections on the Checklist are:
1. Clinical Trial Workforce Register and Training
2. Departmental Policies and Standard Procedures for Clinical Trials Operations
3. Aboriginal and Torres Strait Islander (ATSI) People in Clinical Trials
4. Trial Participants Engagement and Feedback
Each Departmental checklist has a Unique CTW (Clinical Trial Workforce) ID on SAGE. The Owner of each departmental checklist is the Head of Department. If you cannot find the checklist on SAGE, please contact firstname.lastname@example.org to request access. More examples and guidance will be provided as soon as possible.
How to Access your Departmental Checklist?
How to Share your Departmental Checklist with Other Users
How to access your Departmental Checklist