Clinical Trial Submissions

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 Human Research Ethics Committee, and governance authorisation to commence at SA Health sites.

All CDAs must be reviewed by Central Adelaide Local Health Network (CALHN) Research Services.

The contracting party must always be Central Adelaide Local Health Network Inc 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 and/or the study sponsor.

CALHN Clinical Trial Confidentiality Agreement Guideline & Checklist

CALHN Mutual Confidentiality Agreement Template

CALHN Pre-Clinical Trial Agreement Template

All CTRAs must be reviewed by CALHN Research Services. Medicines Australia Clinical Trial Research Agreement templates are available here.

CALHN Clinical Trial MA and MTAA Standard and CRO CTRA Guideline & Checklist

CALHN Clinical Trial CRG & Phase IV CTRA Guideline & Checklist

CALHN Clinical Trial Forms of Indemnity Guideline & Checklist

CALHN Agreement Parties & Signatories Guideline

CALHN Clinical Trial Contract and SSA Submission Guideline & Checklist

CALHN Clinical Trial CTRA Amendment Guideline & Checklist

CALHN Clinical Trial Schedule 7 and 4 Special Conditions to a CTRA Guidance

Invoicing and Fee Form Governance and Ethics CALHN

Note: SA Health Research Ethics and Governance Fee Schedule

All contracts require review by CALHN Research Services.

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.

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

CALHN Guideline for Clinical Trials Budgets, Payments & Invoicing

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.

To apply for ethical review of a Clinical Trial by the CALHN HREC researchers must complete and submit:

• CALHN HREC Clinical Trial Covering Submission Template
• Human Research Ethics Application Form (completed via Research GEMS)
• CALHN HREC and Research Governance Invoicing and Fee form
• Protocol
• Investigator's brochure and/or device product Information
• Radiation statement (if applicable)
• All other study documentation (e.g. eCRFs, participant information sheet and consent forms etc.)

All documents must be submitted via email in searchable PDF format (maximum document size 5MB) with any password protection removed.

Applications must be submitted via Research GEMS.

CALHN Clinical Trial Guideline GEMS Project Registration, HREA & SSA - Internal HREC

Submission deadlines and HREC meeting dates are available here.

Note: under the SA Health Research Ethics and Governance Fee Schedule, a HREC review fee will apply to commercially sponsored studies

For further information, contact CALHN Research Services on 087117 2229, or via email at Health.CALHNResearchEthics@sa.gov.au.