The Australian Commission
on Safety and Quality in Healthcare
has developed the National Clinical Trials
Governance Framework
as a first step towards the accreditation
of health service organizations
for the conduct of clinical trials.
If you work in clinical trials,
you need to become familiar with the governance framework,
and understand what needs to be in place
within your health service organization
to meet the requirements in the governance framework.
The governance framework incorporates the first two
National Safety and Quality Health Service Standards.
These are the clinical governance standard
and the partnering with consumers standard.
These two standards already in place
in all hospital and day procedure services across Australia
for clinical service provision
will now also apply to clinical trial services.
Implementing the governance framework
has the capacity to reduce trial start-up times,
optimize pre-approval and recruitment time-frames,
better engage trial sponsors,
and improve consistency in trial service delivery.
The governance framework describes the roles and functions
for people whose positions relate
to clinical trial service provision,
lists the actions within the National Safety
and Quality Health Service Standards
against what your organization will be assessed,
suggests strategies to help meet these actions,
and provides examples of evidence
the clinical trial services may use
to demonstrate they have met the actions.
Accreditation is an evaluation process
that assesses a health service organization's compliance
with the National Safety
and Quality Health Service Standards by external assessors.
Accreditation assures the community
that clinical trial services
meet expected patient safety and quality standards.
Following the pilot in 2020,
it's anticipated that clinical trial services
will be assessed against the actions
described in the governance framework
using a maturity scale to describe success.
As health service organizations must already meet
the National Safety and Quality Health Service Standards,
preparing for an assessment can build on work
that is already underway
within your health service organization.
Implementing the governance framework
will provide many practical benefits,
including integrating clinical trials
into routine health service provision,
eliminating duplication and delays
in ethical and local site review and approval,
timeliness in trial start-up,
certainty for trial workforce and trial sponsors,
and ensuring predictable recruitment rates.
Get to know the National Clinical Trials
Governance Framework.
Use your existing committees
or establishing a working group
responsible for strategic planning.
This group should be set up in consultation
with your senior management,
and include members of the clinical trials workforce,
consumers, and trial sponsors.
They will work with the organization's management
to implement the governance framework,
allocate resources, and develop mechanisms
to report on and review operational performance
on a regular basis.
The governing body has ultimate responsibility
for safety and quality, and ensuring the standards
as provided in the governance framework are met.
Seeking advice from colleagues
involved in implementing the National Safety
and Quality Health Service Standards at your organization
may also be useful.
Find out who is your accrediting agency.
You will need to ensure the contract
with your accrediting agency
covers assessment of clinical trial services.
Conduct a self-assessment.
Before being assessed by your accrediting agency,
your organization should complete a self-assessment test
of the current systems and processes in place.
A self-assessment tool has been developed
to help you do this.
The tool helps you to identify gaps you may need to address
and provides examples of evidence you can use
to demonstrate actions have been met.
It can also be used to develop action plans
to undertake and track the implementation progress
of the framework within your health service organization.
For all the information and resources you need
to implement the governance framework,
visit the commission's website.