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enabling clinical trial capacity, capability and collaboration across New South Wales

clinicaltrialsNSW is an initiative of the Office for Health and Medical Research, NSW Health to enable clinical trial capacity, capability and collaboration across New South Wales (NSW).

We aim to:

  • establish an entry point for clinical trials in NSW
  • maintain policy directives for clinical trials within NSW Health, drawing on national and international best practice
  • drive transformational change and improvements across the sector
  • monitor and evaluate outcomes of clinical trial initiatives

Our team has national and international experience in:

  • globally-sponsored multi-centre trials
  • product innovation and commercialisation trials
  • collaborative network trials
  • investigator-initiated trials
  • Phase I and First-in-Human trials

Why NSW for clinical trials?

Clinical Trial Connect

Clinical Trial Toolkit

Clinical Trial Triage

Useful resources

  • Organisation
  • Category
  • Website

Standard Operating Procedures—frequently asked questions

What are Standard Operating Procedures?

Standard operating procedures (SOPs) are defined as:

detailed, written instructions to achieve uniformity of the performance of a specific function.

They are controlled documents (version numbered and dated) and are revision-sensitive with a formal release date and periodic revision.

Does GCP require sites to have SOPs?

Yes. ICH GCP (R2) E6 contains two key statements:

  1. Systems with procedures that ensure the quality of every aspect of the trial should be implemented (Principle 2.13) and;
  2. The investigator/institution… should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated (4.2.6).

Why don’t these SOPs cover sponsor responsibilities?

The Draft National Clinical Trials Governance Framework will require organisations sponsoring clinical trials to, delineate sponsor and site activities (trial management versus trial conduct). These are trial conduct SOPs. A separate suite of SOPs for key sponsor functions (including SOPs covering the sponsorship process, protocol/IB development, data management, safety/data monitoring, etc.) are planned.

Are these SOPs and associated templates mandatory?

No. If an organisation has already developed trial SOPs and those SOPs meet the minimum standards set out in the NSW Health Clinical Trial Site SOPs, then the organisation/unit can continue to use their own. It is recommended that a gap analysis be conducted to ensure the topics covered by this suite of SOPs are also covered within existing SOPs. Where gaps are identified, certain SOPs/content from this suite may be adopted.

Why do the SOPs have a footnote about working to ‘principles of GCP’?

Internationally, neither the FDA nor European regulatory authorities require trials to work to full GCP when they are not intended to support a marketing application.

These SOPs are written to facilitate all clinical trials by explicitly recognising that risk-proportionate procedures are appropriate for some trials. This does not mean that trial quality will be compromised as quality is often enhanced through the use of Quality by Design principles that focus on activities that are ‘critical to quality’.

The SOPs have also been written to discourage over-interpretation of ICH GCP that often makes trials more burdensome than they need to be.

How can one set of SOPs work for all NSW Health sites?

The SOPs have been written at a high level so that they can be implemented across all NSW sites. It is recommended, therefore, that any local detail is added in the form of work instructions. One example of a work instruction (and template) is provided with this suite of SOPs.

The diagram explains the hierarchy of three types of controlled documents.

Diagram: hierarchy of three types of controlled documents

Diagram: hierarchy of three types of controlled documents

Download the SOPs template

Early Phase Clinical Trials HREC Scheme—frequently asked questions

What is the definition of an early phase clinical trial (EPCT) in regards to the EPCT Human Research Ethics Committees (HRECs) Scheme?

Early phase clinical trials includes all clinical trial phases up to but not including Phase II. It can also include studies with any Phase I component.

Read the quick reference guide below for more information.

What are the key changes of this scheme?

NSW Health is excluding all adult EPCT from the National Mutual Acceptance (NMA) model. All adult EPCT applications proposed to be conducted in a NSW public health organisation (PHO) site, must be submitted to Bellberry HRECs for ethics review.

Paediatric EPCTs with a NSW PHO lead site are required to be submitted to Sydney Children’s Health Network (SCHN) HREC for ethics review.

Read the quick reference guide below for more information.

Are paediatric EPCTs in NSW exempted from NMA model?

No, for multi-centred paediatric EPCTs, if an HREC hosted in a specialist paediatric tertiary hospital outside NSW has approved a paediatric EPCT, NSW PHO sites will continue to accept interstate HRECs’ approval in these instances.

Read the quick reference guide below for more information.

What is the age group within the scope of Bellberry HRECs for EPCTs?

  • Trials involving adults equal to and greater than the age of 18 years; or
  • Combined paediatric and adult trials involving young people and adults equal to and greater than 16 years.

What is the age group within the scope of SCHN HREC for EPCTs?

  • Trials involving only children and young people under the age of 18; and
  • Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25.

Will Bellberry be acceptable as a lead HREC for NSW PHOs’ for non-early phase clinical trials?

No, the expression of interest (EOI) that Bellberry responded to and were successful, was specifically for reviewing EPCTs. There is currently no plan to expand Bellberry’s commission to non-EPCTs.

Is Bellberry recognised in the NMA scheme? Do/will other jurisdictions recognise Bellberry approvals for multi-centre trials with centres in their states? Or will multiple HREC approvals be required? For example, if I set up a Phase I trial in NSW and obtain HREC approval from Bellberry, can my colleague in Victoria use that approval or does they need to go to another NMA HREC?

All private (and many university) sites in NSW and other jurisdictions currently accept Bellberry approvals. This scheme expands the acceptance of Bellberry approvals to EPCTs in NSW public health organisations (PHOs) as well. We welcome PHOs in other jurisdictions to accept a Bellberry-approved EPCT, but this is up to the individual jurisdictions. This scheme does not establish Bellberry as an NMA HREC.

For combined Phase I/II trials where the Phase I component of the trial is complete, does the request for ethics review of the Phase II component need to be submitted to the NSW Health EPCT HRECs?

No. For combined Phase I/II trials where the Phase I component of the trial is complete, Phase II ethics review applications do not have to be submitted to NSW Health EPCT HRECs. They can be submitted through the normal state-based single ethical review system or NMA scheme.

Updated 3 months ago