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.CALHNResearchGovernance@sa.gov.au

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.

Confidentiality Agreement Checklist

CALHN 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.

Site Specific Assessment (SSA) Form Guidelines

SSA Annual Declaration Form for Research Personnel

Full Site Specific Assessment Form Checklist

Insurance Cover Guidelines and Checklist

SA Health Legal Governance and Insurance Services Research Trials Flowchart

Participant Information and Consent Form Guidelines

SSA Amendment Form

Project Resourcing

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

Clinical Trial Budget – Schedule 2 Preparation Invoicing and Payment Guidelines

Clinical Trial Budget Guidelines and Assistance

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.