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).
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.
All Clinical Trial Research Agreements must be reviewed by the CALHN Research Office.
Medicines Australia Clinical Trial Research Agreement templates are available here.
All 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.
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.
All applications must provide a detailed budget approved by the appropriate delegate.
The following are links to free on-line ICH/Good Clinical Practice (GCP) training modules:
- Syneos Health (formerly INC Research): https://www.shclinicalsiteeducation.com
- Global Health Network Training Centre: https://globalhealthtrainingcentre.tghn.org/ (also available: Introduction to Clinical Research)
Each require the user to register for a login before commencing the training modules.
The following links contain information regarding research ethics, research governance and conduct, and information privacy.