Below is some information taken from the ACSQHC website:

The National Clinical Trials Governance Framework

Jurisdictional endorsement of the National Clinical Trials Governance Framework (Governance Framework) and recommendations for implementation.

In February 2022, all jurisdictions agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is core health service business) under the Australian Health Service Safety and Quality Accreditation Scheme (AHSSQA) Scheme. That is, health service organisations will be assessed concurrently for clinical and corporate services and clinical trial service provision.

To give health service organisations time to implement the Governance Framework, for the first three-year accreditation cycle, they will be assessed against a maturity scale. That is, health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the National Safety and Quality Health Service (NSQHS) Standards (as provided in the Governance Framework) for clinical trial service provision.

Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of their clinical trial services under the AHSSQA Scheme, and be assessed as either having met or not-met the actions within the NSQHS Standards Clinical Governance Standard and Partnering with Consumers Standard (as provided in the Governance Framework) and receive 90 days to remediate.

Implementation will commence in the second half of the year, in alignment with assessment to health service organisations to the NSQHS Standards. 

The Governance Framework is currently undergoing final design and will be published on the Commission’s website shortly.

The Governance Framework is recognised as a significant reform for the clinical trials sector. The Governance Framework embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

The Australian Commission on Safety and Quality in Health Care (the Commission) will update the supporting resources to implement the Governance Framework, and will continue to provide advice to health services through the Safety and Quality Advice Centre.

Standard 1 - 1.15 to 1.20
Standard 2 full recording

Action 1.1 (Governance, Leadership & Culture)

Culture of safety & improvement

SESLHD Research Strategy                            /sites/default/files/SESResearch/Standard%201/SESLHD%20Research%20%20Strategy.pdf

NSWH PD - Ethical & Scientific Review of Research

NSWH PD - Authorisation to Commence Research in PHOs

Partnering with patients, carers & consumers

SESLHD Community Partnership Strategy

Sets priorities & strategic directions
SESLHD Research Strategy                            /sites/default/files/SESResearch/Standard%201/SESLHD%20Research%20%20Strategy.pdf
Endorses the NCTGF
SESLHD has signed an Attestation Statement confirming the District aligns with the National Standards & NCTGF.
Assessors will be made aware of this. 
Roles & responsibilities defined

NSWH PD - Ethical & Scientific Review of Research 

NSWH PD - Authorisation to Commence Research in PHOs

Eg of evidence to collect:
- Position Descriptions of roles specific to organisation/ unit
- Org charts

Monitors actions
Reports on performance

Eg of evidence to collect:
- Monthly performance reports (RD generates monthly performance reports for all REGOs & produces monthly metric reports for MoH)

(no action 1.2 in Framework)


Action 1.3 (Organisational Leadership)
"The health service organisation establishes & maintains a clinical governance framework & uses the processes within the framework to drive improvements in safety & quality."

SESLHD Research Strategy
SESLHD HREC Terms of Reference

Eg of evidence to collect:
- Evidence of educating workforce on key aspects within Framework (training documents, HETI courses, Research education sessions for researchers)
- Review of results from sponsor/ regulatory audits for compliance with Framework
- Reports on clinical trial service provision performance (i.e. Research Office reports & analyses their services provided monthly)
- Manage incidents & complaints relating to clinical trial service provision (SESLHD Clinical Trial Research Complaints Procedure under draft/ review)


Action 1.4 (Organisational Leadership)
"The heath service organisation implements & monitors strategies to meet the organisation's safety & quality priorities for Aboriginal & Torres Strait Islander people"

NSWH PD - ATSI Origin - Recording of Information of Patients & Clients 
St George & Sutherland Hospital Aboriginal Health Implementation Plan 2021 - 2023

Eg of evidence to collect:
- HETI courses relating to priorities for ATSI people: 
     - Aboriginal Culture: Respecting the Difference
     - Aboriginal Culture: Respecting the Difference Face to Face (39988681)
     - Asking the Question: Improving the Identification of Aboriginal People (103260592)
     - Improving the Identification of Aboriginal People (COM913)
- Evidence of asking participants if they are of Aboriginal or Torres Strait Islander origin (in consent forms or systems), keeping records of people's origins. Provision of option for Aboriginal Liaison Officer. 


Action 1.5 (Organisational Leadership)
"The health service organisation or trial site considers the safety & quality of healthcare for patients in its business decision- making"

Eg of evidence to collect:
- Register of safety & quality risks relating to CT service provision - incl. actions to manage identified risks
- Meeting records where quality of CT service provision is considered in business decision- making


Action 1.6 (Clinical Leadership)
"Clinical leaders support clinicians to:
     a. Understand & perform their delegated safety & quality roles & responsibilities
     b. Operate within the clinical governance system to improve the safety & quality of health care for patients"

1.6a Eg of evidence to collect:
- Documents outlining delegated roles & functions of clinical leaders delivering CT services. eg trial investigators, trial coordinators, trial pharmacists
1.6b Eg of evidence to collect:
- Workforce training documents/ training log
- Audit results & actions taken to deal with identified issues (audit on informed consent, GCP training, information provided to participants, participant feedback)

Action 1.7 (Patient Safety & Quality Systems - Policies & Procedures)
"The health service organisation uses a risk management approach to:
     a. Set out, review, maintain the currency & effectiveness of clinical trial policies, procedures & protocols
     b. Monitor & take action to improve adherence to clinical trial policies, procedures & protocols
     c. Review compliance with legislation, regulation & jurisdictional requirements"

1.7a SESLHD Framework for Policies, Procedures, Guidelines & Business Rules
1.7b SESLHD Framework for Legislative Compliance (App A legislative implementation & compliance checklist
1.7c Eg of evidence to collect:
- Legislative compliance register
- Schedule of past reviews & compliance against NSW policy legislation


Action 1.8 (Patient Safety & Quality Systems - Measurement & Quality Improvement)
"The health service organisation uses organisation- wide quality improvement systems that:
     a. Identify safety & quality measures, monitor & report performance & outcomes
     b. Identify areas for improvement in clinical trials safety & quality
     c. Implement & monitor safety & quality improvement strategies
     d. Involve consumers & the workforce in the review of safety & quality performance & systems"

1.8a Evidence:
Summary Metrics 3 & 4 Report for NSW PHOs (publication of CT metrics performance)

Eg of evidence to collect:
- Documents outlining CT service measurements of quality (eg: Metrics 3 & 4 for Research Office, Metric 5 & 6 for commercially sponsored CT.)
- Reports on quality performance to governing body, sponsor or boards
(eg Research Office has monthly CT service provision reports to CQ Council, OHMR)
- site walk arounds/ safety evaluations
- discussions & feedback from participants on safety measures in place

1.8b Eg of evidence to collect:
- Feedback from consumers about involvement in review of performance data - surveys
- Feedback from workforce about use of performance data - internal surveys
- Meeting minutes of CT safety & quality improvement discussions - RSO QSP meeting minutes

Eg of evidence to collect:
- Any specific improvement activities implemented & evaluated
- Audit reports from trial sponsors, internal reports
- Presentations/ analysis of quality performance data to boards, committees

1.8d Eg of evidence to collect: 
- Feedback from consumers about their involvement in review of safety & quality performance data 


Action 1.9 (Patient Safety & Quality Systems - Measurement & Quality Improvement)
"The health service organisation ensures that timely reports on safety & quality systems & performance are provided to:
     a. The governing body
     b. The workforce
     c. Consumers & the local community
     d. Other relevant health service organisations"

NHMRC Guidance on Safety Monitoring & Reporting

NHMRC Risk- Based Management & Monitoring of Clinical Trials

Eg of evidence to collect:
- Annual safety reports/ progress reports
- Reports on CT service provision performance data provided to any stakeholders (governing body, governments, sponsors, CT workforce)
- Meeting records where recommendations by governing body is discussed
- Meeting records where accessibility of performance information is discussed
- Communication with CT workforce & consumers on CT operational performance
- Any publications of CT service provision operation performance information (annual reports, online etc)
- Reporting templates 
- Reporting calendars 

Action 1.10 (Risk Management)
"The health service organisation:
     a. Identifies & documents organisation risks 
     b. Uses clinical & other data collections to support risk assessments
     c. Acts to reduce risks
     d. Regularly reviews & acts to improve effectiveness of risk management system
     e. Reports on risks to workforce & consumers
     f. Plans for & manages internal & external emergencies & disasters"


SESLHD Enterprise Risk Management System (ERMS) Procedure 

SESLHD Emergency Disaster Management Policy

NHMRC Risk- Based Management & Monitoring of Clinical Trials

NHMRC Reporting of Serious Breaches of Good Clinical Practice

NHMRC Guidance on Safety Monitoring & Reporting

Eg of evidence to collect:
- Organisational/ enterprise risks that come from research added into ERMS & monitored accordingly. 
- Risk register including actions taken to manage identified risks relating to CT provision
- Reports on safety & quality data. annual safety reports, progress reports 
- Meeting records where risk & accessibility of safety & quality information has been discussed
- Communication with workforce on risks & risk management
- Training documents relating to risk management, managing emergencies, fire training & evacuation drills.

Action 1.11 (Incident Management Systems & Open Disclosure)
"The health service organisation or trial sire has organisation- wide incident management information & investigation systems, and:
     a. Supports the workforce to recognise & report incidents
     b. Supports patients, carers & families to communicate concerns or incidents
     c. Involves the workforce & consumers in the review of incidents
     d. Provides timely feedback on the analysis of incidents to the governing body, workforce & consumers
     e. Uses the information from analysis of incidents to improve safety & quality 
     f. Incorporates risks identified in the analysis of incidents into the risk management system
     g. Regularly reviews & acts to improve the effectiveness of the incident management system & investigation systems."


NSW Health Incident Management Policy

NSW Health Managing Misconduct Policy

SESLHD Assessment & Management of Serious Incidents

SESLHD Complaint Handling Framework 

SESLHD Research Complaints Management Procedure
(sent to policy for approval - TBC)

NHMRC Research Integrity & Misconduct Policy

NHMRC Guide on Managing & Investigating Potential Breaches of the Research Code

Eg of evidence to collect:
-  An accessible incident reporting system - (IMS+, ERMS) training on such systems
- Policy documents for reporting, investigating, managing incidents - (as above)
- Information on clinical incidents & near misses, actions taken
- Meeting records relating to incident recording & management

Action 1.12 (Incident Management Systems & Open Disclosure)
"The health service org:
     a. Uses an open disclosure program that is consistent with the Australian Open Disclosure Framework 
     b. Monitors & acts to improve the effectiveness of open disclosure processes. 


SESLHD Open Disclosure Policy

Eg of evidence to collect:
- Reports on open disclosure

Action 1.13 (Feedback & Complaints Management)
"The health service organisation:
     a. Has processes to seek regular feedback from patients, carers & families about their experiences & outcomes of care
     b. Has processes to regularly seek feedback from workforce on understanding & use of safety & quality systems
     c. Uses this information to improve safety & quality systems"

Eg of evidence to collect:
- Data collection tools for collecting CT workforce, trial sponsor, trial participants, carers feedback
- Feedback forms provided or website links to feedback

Action 1.14 (Feedback & Complaints Management)
"The health service organisation or trial site has a complaints management system and:
    a. Encourages & supports patients, carers & families & the workforce to report complaints
     b. Involves the workforce & consumers in review of complaints
     c. Resolve complaints in a timely way
     d. Provides timely feedback to governing body, workforce & consumers on the analysis of complaints & the actions taken
     e. Uses information from the analysis of complaints to inform improvements in safety & quality systems
     f. Records risks identified from analysis of complaints in risk management systems
     g. Regularly reviews & acts to improve the effectiveness of the complaints management system"


Ministry for Health Managing Misconduct Policy

SESLHD Complaint Handling Framework

SESLHD Research Ethics & Governance Complaints Procedure - under comment at CQC
*insert procedure*

Eg of evidence to collect:
- Trial site complaints register including responses & actions, schedule for review
- Training documents about complaints management system (IIMS HETI training, ERMS training)
- Consumer complaints forms & information
- Audit results of complaints management compliance

Action 1.15 (Diversity & High- Risk Groups)
"The health service organisation or trial site:
     a. Identifies the diversity of the consumers using its services
     b. Identifies groups of patients using its services who are at higher risk of harm
     c. Incorporates information on the diversity of its consumers & higher- risk groups into planning & delivery of care"

1.15a SESLHD Vulnerable & Priority Populations Report (2018)

SESLHD Journey to Excellence (App A)

SESLHD Translated Health Information Policy


NSWH PD - Ethical & Scientific Review of Research

NSWH PD - Authorisation to Commence Research in PHOs



SESHD webpage for interpreter services
Interpreters | South Eastern Sydney Local Health District (

Eg of evidence to collect:
- Consumer and trial participant information that is available in different formats and languages that reflect the diversity of the patient population.
- Documents relating to planning of projects for higher risk participants (HREAs, correspondence with HREC)

Action 1.16 (Healthcare Records)
"The health service organisation or trial site has healthcare records systems that:
     a. Make the healthcare record available to clinicians at the point of care
     b. Support the workforce to maintain accurate and complete healthcare records
     c. Comply with security and privacy regulations
     d. Support systematic audit of clinical information
     e. Integrate multiple information systems, where they are used"

1.16a iPM system, eMR...
- Observation that electronic records access is at the point of care/ at trial site
1.16b - Signed workforce confidentiality agreements 
- Code of conduct including privacy & confidentiality of consumer information 

SESLHD Records Management

SESLHDPR/336 Documentation in the Health Care record
SESLHDPR/292 Hybrid Healthcare Record Procedure

PD2020_046 - Electronic Information Security Policy 
PD2015_049 - Code of Conduct
NSW PD2009_076 - Communications: Use & Management of Misuse of NSW Health Communications Systems

1.16d - Evidence of audit reports relating to health records management (from external auditor from SES and/or sponsors)

Eg of evidence to collect:
- Records of ethics approval for research activities that involve sharing patient information.
- Secure archival storage & disposal systems
- Auditors will probably ask to see access to records/ record management on trial sites. 

Action 1.20 (Clinical Performance & Effectiveness)
"The health service organisation uses its training systems to:
     a. Assess the competency and training needs of its workforce
     b. Implement a mandatory training program to meet its requirements arising from these standards
     c. Provide access to training to meet its safety and quality training needs
     d. Monitor the workforce’s participation in training"

1.20a SESLHD Environmental Sustainability Plan 2019-2021 

- NSW Health mandatory HETI training matrix
- GCP training records of research staff
- Schedule of clinical trial education & training (RSO webinars, coordinator working groups, training on- site)

1.20c - SESLHD education page (webinars, HETI courses relating to research)
Research education | South Eastern Sydney Local Health District (
- HETI training opportunities
- Annual HREC training schedule, attendance 
1.20d - SESLHD RSO training logook


Eg of evidence to collect:

- HETI transcript records of trial staff
- GCP certificates 
- assessment of workforce capacity through audits, reports 


Action 2.1 
"Clinicians use the safety & quality systems from the Clinical Governance Standard (Standard 1) when:

2.1a - Implementing policies and procedures for partnering with consumers 
2.1b - Managing risks associated with partnering with consumers 
2.1c - Identifying training requirements for partnering with patients and consumers"


a - SESLHD Collaborative Research Committee - should be including consumers within the membership.
a - POW/SSEH Partnering with Consumers Framework - other PHOs may have similar
a - All research- related policies written by the RSO go out to the District for comment so researchers throughout the District can comment (if viewing the RSO's consumers as the research workforce)
b - 
c - - targeted HETI training for researchers.
Planning and Partnerships Team of SESLHD to help assist with making health literacy for participants. 
- NSW Health Literacy framework

Examples of evidence to collect: 

- Feedback from consumers in relation to their experiences with the trial & governance. 
- Meeting minutes including engagement with consumers.
- Physical resources on trial sites that are available to support consumer participation.
- Interviews with researchers that show they understand the HSOs process for partnering with consumers. 
- data from risk management & reporting systems on risks & mitigation strategies to partner with participants. 
- Interviews with trial participants on their safety during participation, support options available to them i.e. provision of the option to have an Aboriginal Patient Liaison Officer for any Aboriginal or Torres Strait Islander participants, mental health support or counselling services provided if any etc. 
- Procedures relating to shared decision making and planning care relating to participation in a clinical trial
- Procedures relating to informed consent
- Any ethically approved translations of PISCFs, advertisements, letters of invitation.
- Risk assessments for training needs of researchers.
- Training records of researchers participating in HETI courses or other training sessions relevant to partnering with consumers (HETI - Working in Culturally Diverse Contexts, Diverse Populations Learning Unit, Working with Consumers and Communities, Person Centered Care etc.)
- Evidence of advertisements, recruitment processes etc. to show engagement with consumers 


Action 2.2 

"The health service organisation applies the quality improvement system in the Clinical Governance Standard when:

2.2a - Monitoring processes for partnering with consumers
2.2b - Implementing strategies to improve processes for partnering with consumers
2.2c - Reporting on partnering with consumers"
(relevant actions 1.8 quality improvement, 1.9 reporting, 1.11 incident management) 


- SESLHD Research Strategy 2017 - 2021 
- Journey to Excelence 2017 - 2021
- TEMPLATE TO COMPLETE - Organisational Self- Assessment Survey for Consumer Engagement… - patient information page


Examples of evidence to collect: 

Results of consumer and carer experience surveys.
- Reviews of incidents determining areas of concern in consumer partnerships. 
- Examples of any improvement initiatives & evaluation of success/ implementation. 
- Meeting minutes in which feedback from consumers & the workforce on safety & quality systems.
- Consumer/ participant information packages or resources provided.
- Reports on safety & quality performances in reports, articles, webpages etc.
- Reports to the RGO & sponsor relating to any safety event or issue relating to consumers, the mitigation strategies developed from these incidents.
- Audits or gap analysis of consumer partnerships & engagement.


Action 2.3

"The health service organisation uses a charter of rights that is:
2.3a - consistent with the Australian Charter of Healthcare Rights;
2.3b - Easily accessible for patients, carers, families & consumers"


- SESLHD PISCF template - 3 x SES templates now include a sentence on the Charter, a QR code to the Charter for easy access, website link to the AQSQHC Charter webpage. 
- Addition of Charter downloadable in top 6 spoken languages in SESLHD on the Research webpage at…

Evidence to collect: 

- Evidence of Charter displayed in common areas - trial site, waiting rooms etc.
- Evidence that the Charter was discussed or provided participants.



Action 2.4 

"The health service organisation ensures that its informed consent processes comply with legislation and best practice."

- Inclusion of informed consent training on SESLHD Research website…

Evidence to collect:
- Training documents on informed consent courses or training. 
- Standard patient information & consent forms.
- Audit for compliance with consent processes. 
- HREA answers for capacity of participants to consent, processes on consenting participants, discussions on consenting minors/targeted groups to show ethically approved & best practice.
- Evidence that the consent forms are stored within the PHO adequately. 
- Evidence of PISCFs or information packages in other languages & evidence of such forms being used for consenting participants. 

- Participant feedback that they were properly informed & consented. 



Action 2.5
"The health service organisation has processes to identify:
2.5a - The capacity of a patient to make decisions about their own care
2.5b - A substitute decision-maker if a patient does not have the capacity to make decisions for themselves."

Evidence: - Capacity Workshop & IDMH-10 Consent, Decision- Making & Privacy: A Guide for Clinicians - HETI courses

Evidence to collect:
- Education received by the workforce on informed consent, training documents
Evidence of PISCF or consent form nominating substitute decision- maker
- audit for compliance with assessing capacity & having a substitute carer consent. 


Action 2.8
"The health service organisation uses communication mechanisms that are tailored to the diversity of the consumers who use its services and, where relevant, the diversity of the local community."

- SESLHD Research Strategy 2017 - 2021 
- Journey to Excelence 2017 - 2021
SESLHDPD/325 Translated Health Information - discusses research documents & tools 
- HETI Training - 
Respecting the Difference: An Aboriginal Cultural Training Framework, Working in Culturally Diverse Contexts

Evidence to collect: 
- Patient facing documents translated into different languages, the translation certificates, HREC approval
- Assessments identifying the diversity of the community
- Demographic data used in strategic planning
- Audits for translator use, assessment of accessibility to translators
Training documents about cultural awareness and diversity
- Consumer and carer information packages or resources that are culturally appropriate, available in different languages and accessible formats.
- Feedback from participants on whether communication processes met needs


Action 2.9
"Where information for patients, carers, families and consumers about health and health services is developed internally, the organisation involves consumers in its development and review."


Evidence to collect:
Committee and meeting records that show consumer involvement in the development and review of clinical trials information in general and clinical trial service information resources
- Feedback from consumers who have used the health service organisation’s clinical trial information publications
- Communication with consumers who provided input into the development or review of resources about the types of changes made in response to their feedback.


Action 2.10
The health service organisation supports clinicians to communicate with patients, carers, families and consumers about health and health care so that:

2.10a - Information is provided in a way that meets the needs of patients, carers, families and consumers
2.10b - Information provided is easy to understand and use
2.10c - The clinical needs of patients are addressed while they are in the health service organisation
2.10d - Information needs regarding their ongoing care are provided on discharge."



Evidence to collect:
A register of interpreter and other advocacy and support services available to the clinical trial work force trial participants, their carers and families
- Examples of information materials provided to trial participants and their carers and families that are in plain language, and available in different languages and formats
- Results of patient and carer experience surveys regarding the information provided
- Feedback from trial participants and carers about


Action 2.14
"The health service organisation works in partnership with patients and consumers to incorporate their views and experience into training and education for the workforce."


Evidence to collect:
- Project plans, communication strategies or consultation plans that describe the involvement of consumers in the development of training curriculums and materials
- Committee and meeting records in which training curriculums for the workforce were discussed and feedback was provided by consumers
- Training documents that incorporate trial participants consumers’ views and experiences
- Records of training or presentations provided to the workforce by consumers
- Feedback from consumers