Workbook to assist with implementation of the Framework
This resource is designed to help members of the clinical trial workforce understand their responsibilities under the National Clinical Governance Framework (“the framework”). It should help clinical trials workforce members be able to demonstrate this understanding to assessors during accreditation.
This workbook is separated into sections according to the different parts of the workforce as mentioned in the framework. The different sections are:
- Clinical and Non-Clinical Managers
- Research Office
- Clinical Trial Workforce
- Clinician Investigators
- Supporting Departments
- Partnering with Consumers Department
- Governing Body
- Service User/Consumer
The full workbook is broken down into 3 sections: a section on the background of the Framework and your role, Standard 1 and Standard 2.
The Melbourne Academic Centre for Health (MACH) would like to acknowledge the Office of Health and Medical Research, DHHS and MACH health service partners for funding the Implementation of the National Clinical Trials Governance Framework (the “Framework’) project. MACH would also like to acknowledge the support by Murdoch Children’s Research Institute (MCRI) for hosting the project team.
In the section below the standards 1 and 2 have been separated into different roles within the workforce. Identify the part of the workforce you belong to, and click to receive targeted information about your responsibilities under the National Clinical Trials Governance Framework.
The National Clinical Trials Governance Framework (“the framework”) is being put in place as an extension to the current hospital accreditation scheme (the National Safety and Quality Health Service Standards, “the NSQHSS”), managed by the Australian Commission for Safety and Quality in Healthcare (“the Commission”). For the first time, the clinical trials service will be included in a Health Service Organisation’s (HSO) accreditation.
The framework is aiming to achieve the following:
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- Nationally consistent approach to clinical trial governance (i.e., because HSOs are accredited under the framework, they have a consistent approach to governance under the framework)
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- Integration of the clinical trial service into routine clinical services
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- Embedding the clinical trial service into clinical and corporate governance systems, and strategic and operational planning for service provision at an organisational level
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- Increased visibility, awareness, and transparency of the clinical trials service to the rest of the organisation, including the governing body and the service users
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- Increased awareness of, and opportunities to participate in, clinical trials and research
The framework is made up of Standard 1: Clinical Governance and Standard (Part 2 of the workbook) and Standard 2: Partnering with Consumers (Part 3 of the workbook). Each standard is made up of a set of actions, and evidence must be provided to show that the organisation meets that action. To support them in this, each action is also accompanied by lists of key tasks and suggested evidence.
The actions within the two standards of the framework align with the matching actions in the two standards of the NSQHSS, so that everyone in the organisation is working towards the same goals and meeting the same actions. This also means every action in the framework will be assessable under the current hospital accreditation scheme (the NSQHSS).
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
More in-depth guidance on the list of responsibilities relevant to your part of the workforce can be found below. This checklist also contains information on who else has that responsibility, a set of reflective questions to help you understand and be able to demonstrate your responsibilities to assessors, and space for you to type notes and list evidence.
To access the extended checklist for standard 1, click here.
To access the extended checklist for standard 2, click here.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
More in-depth guidance on the list of responsibilities relevant to your part of the workforce can be found below. This checklist also contains information on who else has that responsibility, a set of reflective questions to help you understand and be able to demonstrate your responsibilities to assessors, and space for you to type notes and list evidence.
To access the extended checklist for standard 1, click here.
To access the extended checklist for standard 2, click here.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
More in-depth guidance on the list of responsibilities relevant to your part of the workforce can be found below. This checklist also contains information on who else has that responsibility, a set of reflective questions to help you understand and be able to demonstrate your responsibilities to assessors, and space for you to type notes and list evidence.
To access the extended checklist for standard 1, click here.
To access the extended checklist for standard 2, click here.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
More in-depth guidance on the list of responsibilities relevant to your part of the workforce can be found below. This checklist also contains information on who else has that responsibility, a set of reflective questions to help you understand and be able to demonstrate your responsibilities to assessors, and space for you to type notes and list evidence.
To access the extended checklist for standard 1, click here.
To access the extended checklist for standard 2, click here.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
No extended checklist is available for this role.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance. For this role only standard 1 is applicable.
To access the checklist for standard 1, click here.
More in-depth guidance on the list of responsibilities relevant to your part of the workforce can be found below. This checklist also contains information on who else has that responsibility, a set of reflective questions to help you understand and be able to demonstrate your responsibilities to assessors, and space for you to type notes and list evidence.
To access the extended checklist for standard 1, click here.
The checklist which can be used as a stand-alone tool, without any guidance. Standard 2 is applicable for partnering with consumer department.
To access the checklist for standard 2, click here.
No extended checklist is available for this role.
This workbook is written using a medium-sized tertiary HSO as the model, and the workforce parts and division of framework responsibilities are based off of this.
The checklist which can be used as a stand-alone tool, without any guidance.
To access the checklist for standard 1, click here.
To access the checklist for standard 2, click here.
No extended checklist is available for this role.
Please see below other resources that might be useful for you.
Please see below other useful links that might be useful for you.
- The National Clinical Trials Governance Framework ACSQHC- https://youtu.be/h3fi5D4RVRE
- Metrics and You Project (VCCC)-https://vcccalliance.org.au/our-work/research-and-translation/clinical-trial-innovations/metrics/
- Metrics and You booklet- https://vcccalliance.org.au/assets/Clinical-trials-docs/e7943ca0bb/Metrics-and-You-V1-May-2023.pdf
- Consumer engagement toolkit (VCCC)- https://vcccalliance.org.au/our-work/consumer-engagement/toolkit/
- Telethon Kids Institute- https://www.telethonkids.org.au/be-involved/help-shape-our-research/
- Sydney Health Partners- https://sydneyhealthpartners.org.au/resources/consumer-and-community-involvement-resources/
- Consumer and Community Involvement Program –https://cciprogram.org/resources/
- Health Consumers NSW – https://www.hcnsw.org.au/news-resources/tools-and-resources/
- NHMRC Consumer and community engagement- https://www.nhmrc.gov.au/about-us/consumer-and-community-engagement
- A Consumer and Community Engagement Framework for the South Australian Health and Medical Research Institute (SAHMRI)- https://sahmri.org.au/assets/20200515_SAHMRI-Consumer-and-Community-Engagement-Framework_Version2.pdf
- Consumer and Community Engagement Framework (CINSW)- https://www.cancer.nsw.gov.au/getmedia/3109d65f-6135-4df5-82a5-59fc4408159b/Consumer-Community-Engagement-Framework.pdf