Each clinical trial to be conducted at a site within SA Health and sponsored by a third party external to SA Health must be governed by a written agreement clarifying the obligations and responsibilities of the parties involved in the trial.

Clinical Trials require both ethical approval from the relevant HREC and governance authorisation to commence at SA Health sites.

The research governance review process for clinical trials may involve (but is not limited to) assessment of the following:

  • Compatibility of the research project with the CALHN’s research aims
  • Feasibility of the research project with consideration of the required resources at CALHN (e.g. financial, human resources, infrastructure)
  • Expertise and experience of researchers, and ensuring that training for research staff is undertaken as required
  • Compliance of the research project with relevant laws, policies and guidelines (e.g. radiation safety,
  • Confidentiality, intellectual property, biosafety and licensing standards).

For further information about CALHN approval processes for Clinical Trials email. Health.CALHNClinicalTrials@sa.gov.au

Information about post-approval monitoring requirements for clinical trials is located under the Safety Monitoring here

Research GEMS – Submission guidelines

SA Health has implemented a new research application management system called Research Governance and Ethics Management System (Research GEMS) to replace Online Forms for submission of HREA and SSA applications. 

Researchers must ensure that all relevant study documentation (eg study protocol, Participant Information and Consent Form etc) are provided via Research GEMS, in addition to completion of the relevant form(s).

CALHN GEMS Guideline – Preparing Project Registration and HREA

CALHN HREC Submission Covering Letter

CALHN GEMS Guideline – Preparing SSA Applications

CALHN Research GEMS Demonstration – BHI Presentation Slides 08 April 2021 

Confidentiality Disclosure Agreement (CDA)

All confidentiality agreements must be reviewed by the CALHN Research Office.

The contracting party must always be Central Adelaide Local Health Network Inc (CALHN) and NOT the Principal Investigator. Principal Investigators must NOT sign CDAs on behalf of CALHN.

Wherever possible, Clinical trial-related CDAs should be mutual (i.e. all parties will be sharing confidential information).

This is in order to protect any CALHN confidential information that may be shared with the Clinical Research Organisation (CRO) and/or the study sponsor.

CALHN Clinical Trial Confidentiality Agreement Guideline & Checklist

CALHN Clinical Trial Mutual Confidentiality Agreement Template

CALHN Pre-Clinical Trial Agreement Template

Contract Review

All research contracts require review by the Research Office.

The Research Contracts Officer negotiates contact terms regarding these agreements between various parties and CALHN, including staff members, Universities and other Hospitals, SAHMRI and National and International companies.

Intellectual Property and/or Finance (other than a grant) agreements also require review.

Contact the Research Contracts Officer for further information.

Site Specific Assessment (SSA)

The Site Specific Assessment (SSA) Form should be used for governance assessment of research projects involving more than low risk to participants, and where the research proposal has been submitted for ethical and scientific review using the National Ethics Application Form (NEAF).

The SSA process considers the following:

  • Adequate resources (financial, human, equipment and infrastructure) for the research to proceed at the site and identified as appropriate, accountable and available;
  • Researchers have the necessary expertise and experience (Medical Officers must be credentialed by the CALHN Credentialing Office in order to conduct clinical research); if not, relevant training is planned before carrying out their role in the research study.
  • Compliance with relevant laws, policies and codes of conduct relating to matters such as privacy, confidentiality, consent, bio-safety, professional standards, and radiation safety.

SSA submissions for clinical trials must be submitted via Research GEMS

CALHN Clinical Trial GEMS Project Registration and SSA Guidelines

Invoicing and Fee Form – Governance and Ethics

CALHN Clinical Trial Study Team Declaration

CALHN Research Department Head Declaration

CALHN Clinical Trial Data Custodian Declaration (if applicable)

CALHN Participant Information and Consent Form Guidance – CALHN HREC

CALHN Participant Information and Consent Form Guidance – External HREC

SA Health Legal Governance and Insurance Services Research Trials Flowchart

 

Project Resourcing

All applications must provide a detailed budget approved by the appropriate delegate.

CALHN Guideline for Clinical Trials Budgets, Payments & Invoicing

CALHN has standardised set-up and administrative fees across all clinical trials.

CALHN Clinical Trial Standardised Fee Schedule 

ICH/Good Clinical Practice (GCP) Training

The following are links to free on-line ICH/Good Clinical Practice (GCP) training modules:

Each require the user to register for a login before commencing the training modules.

Ethical Review – National Mutual Acceptance

Australian state and territory Departments of Health have signed a Memorandum of Understanding for mutual acceptance of scientific and ethical review of multi-centre human research projects undertaken in Public Health Organisations, known as the National Mutual Acceptance scheme (NMA).

CALHN is a participating NMA organisation and the Central Adelaide Local Health Network HREC is a NMA Certified Human Research Ethics Committee.

Please note: Under the SA Health Research Ethics Policy Directive South Australian public health institutions do not accept HREC approval under the NMA scheme for First in Human, Phase 0 and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander projects. These projects must be submitted for ethical review by a SA Health HREC.

Further information about CALHN HREC member composition, meeting dates, submission deadlines and contact details is available here.

Further information about the National Mutual Acceptance scheme, and a list of participating HRECs and Organisations is available here.