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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.

CALHN Research Services follows the National Health and Medical Research Council (NHMRC) Guidelines which can be found here.

Please note SA Health has updated the SA Health Research Ethics and Governance Fees Schedule effective 01 July 2024.

Contact Health.CALHNClinicalTrials@sa.gov.au or (08) 7117 2231 if you would like any assistance with your GEMS submission or for further information.

Confidentiality Disclosure Agreements (CDAs)

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

Clinical Trial Research Agreements (CTRAs)

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.

Medicines Australia Clinical Trial Research Agreement templates are available here.

CALHN Clinical Trial Contract and SSA Document Guideline and Checklist

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

CALHN Clinical Trial CRG & Phase IV CTRA Guideline & Checklist

CALHN Clinical Trial CTRA Amendment Guideline & Checklist

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

CALHN Clinical Trial Forms of Indemnity Guideline & Checklist

CALHN Agreement Parties & Signatories Guideline

CALHN Research Electronic Signature Platforms Information

CALHN Invoicing and Fee Form

SA Health Fee Schedule

Site Specific Assessment (SSA) Submissions

An SSA must be completed 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.

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 Site Specific PICF Guidelines
CALHN Clinical Trial Guideline GEMS Project Registration, HREA & SSA - Internal HREC
CALHN Clinical Trial Guideline GEMS Project Registration & SSA - External HREC
CALHN GEMS Guideline - SSA Part C - Approvals from Departments and Services
CALHN Invoicing and Fee Form
CALHN Clinical Trial Study Team Declaration
CALHN Annual Clinical Trial Study Team Declaration
CALHN Principal Investigator Declaration
CALHN Research Department Head and Medical Lead Declaration
CALHN Clinical Trial Data Custodian Declaration (if applicable). The Clinical Trial Data Custodian Declaration is applicable for researchers seeking access to paper records or external data.
A copy of the HREC approval letter and all documents approved by the reviewing HREC (via shared Clinical Trial drive)
Any site specific documentation requiring local research governance approval (e.g. site specific Participant Information and Consent Forms)

Project Resourcing

Clinical Trial Notification Scheme and Clinical Trial Approval Scheme

The Therapeutic Goods Administration (TGA) must be notified of clinical trials of unapproved therapeutic goods via the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme.

If a CTN is required please contact CALHN Research Services via Health.CALHNClinicalTrials@sa.gov.au who will submit the CTN for you.

Information for completing a CTN where CALHN HREC is the reviewing HREC and/or CALHN is the Approving Authority is available here.

If a CTA is required, please follow the TGA CTA instructions.

CARPARK ROAD WORKS – follow signage and directions on entry

Clinical Trial Submissions

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