Research governance at NALHN

The Research Governance Office is keen to discuss your project proposals with you at an early stage wherever possible and can help navigate the necessary paperwork needed to lodge a research application.

In accordance with the SA Health Research Governance Directive (PDF 319KB), all research within the Northern Adelaide Local Health Network (NALHN) requires authorisation of the delegated officer (Executive Director, Medical Services) before commencing.

At a minimum, this will includes a Site-Specific Assessment (SSA) (either a full SSA or Low/Negligible Risk form), research protocol, ethics approvals, and other supporting documents, depending on the type of study.

Submission guidelines

Submission Guidelines for the most common studies, including instructions and tool kits to help prepare a research governance application:

How to Submit an application

All applications needs to be submitted to the Research Governance Office. Instructions and checklists are available to assist in the process of how to submit an application.

Research Governance support and advice:

Good Clinical Practice Certificate

As part of the implementation of the National Clinical Trials Governance Framework and the Therapeutic Goods Administration (TGA) GCP Inspection Audits, investigators will be required to undertake GCP training and subsequent refresher training to meet compliance as mandated by SA Health.

Health Networks are working with SA Health towards ensuring that all staff involved in any clinical research (not only those involved in the design and conduct of clinical trials) undertake GCP training and hold a current certificate in GCP. This includes principal investigators, associate investigators, trial managers/coordinators and research nurses etc.

To ensure NALHN is compliant with the minimum training requirements, all staff (NALHN, SAHMRI, University etc) involved with undertaking any clinical research at NALHN must undertake GCP training. Evidence of GCP training will be part of the research ethics and research governance approval processes.

Certificates are kept on file in the Research Governance Office, so if you have provided a certificate within the past two years, you do not need to provide it with every new SSA application. Further information can be found on the Therapeutic Goods Administration website.

Please note: This is interim advice and further information will be provided when available.

Contact us

Research Governance Officer

Phone: (08) 8182 9346
Email: healthnalhnrgo@sa.gov.au
Address:
Lyell McEwin Hospital
Level 2 Clinical Trials Unit
Haydown Road
Elizabeth Vale SA