Accreditation

What is Accreditation?

Australian Health Service Safety and Quality Accreditation Scheme  

Under the National Health Reform Act 2011, the Australian Commission on Safety and Quality in Health Care oversees national healthcare standards and coordinates the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. This scheme guides accrediting agencies and covers key standards, including the National Clinical Trial Governance Framework.

For further information on the Accreditation program for the National Standards, visit the RCH National Standards webpage. Please note this page is only accessible to staff with an RCH Login. 

 

 

 

What is the National Clinical Trials Governance Framework?

The National Clinical Trials Governance Framework (NCTGF) sets the national standards for clinical trial conduct and accreditation in healthcare. It covers all hospital services supporting trials and outlines staff roles and responsibilities. The Commission has created a video explaining the NCTGF.

 

Sampling for Clinical Trials and Assessment Methodology

Sampling

The assessors will select up to 30 trials to assess. This will include any clinical trials only involving RCH patients.   

 

Assessment methodology

Assessors collect evidence through:

  • Interviews with staff, consumers, trial participants, sponsors, and others
  • Observations of practices and interactions across clinical areas
  • Document reviews to verify policies, compliance, and outcomes
  • Evaluation of quality improvement systems for risk reduction

 

How can I prepare for Accreditation?

We have a number of Fact Sheets available to assist you. 

1.      Clinical Governance – Clinical Trials Tip Sheet

2.      Partnering with Consumers – Clinical Trials Tip Sheet

3.      Melbourne Children’s Campus – How to prepare for NCTGF Accreditation 

4.      Melbourne Children’s Campus – NCTGF Accreditation – sample questions 

5.    Check out the

 

 

Frequently Asked Questions

Yes—if you're an MCRI staff member running clinical trials in a hospital, your trials fall under the National Clinical Trials Governance Framework (NCTGF). As part of hospital accreditation, all health service organisations, including MCRI as RCH Research Partner, are assessed against NCTGF standards due to MCRI’s collaboration with RCH in conducting clinical trials.

RCH is part of the Short Notice Assessment Program (SNAP), with accreditation expected anywhere between July – November 2025

Expect a team of 5–6 assessors, including 2 focused on clinical trials.

The assessors will be at RCH for 4 full days.

The Quality Department and REG Office will provide assessors with a list of open trials. Up to 30 trials will be selected. If yours is chosen, the PI and Coordinators will be notified by email and a phone call. Make sure your information in DERP is current!!

You’ll receive a scheduled time to meet with assessors. Be ready for a brief (approx. 1 hour) visit to your area. They’ll want to see where and how your trial is delivered.

The PI and Trial Coordinator (or delegates) must attend. Other team members should also be available—they may be asked about the trial

Yes. They may meet with participants on-site on the day or request online chats with consumers. This will be arranged with your team during the week.

Accreditation goes ahead regardless. If you’re unavailable, ensure other team members are ready to meet with assessors.

The REG Office and CRDO/MCTC teams ([email protected]) will support you throughout the week—scheduling, room bookings, answering questions, and liaising with RCH Quality team and assessors