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Clinical trial research agreements
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We endorse and encourage the use of the following standardised clinical research agreements:
Tasmanian Specific Clauses
The CTRAs/CIRA must include the Tasmanian Specific Clauses, which are inserted at ‘Special Conditions’ (either Schedule 4 or Schedule 7 depending upon the contract type) to ensure full compliance with Treasurer’s Instruction, ‘Contracts – Disclosure and Confidentiality in Government Contracting’.
Special Conditions
- Amendment to definition of Confidential Information
The parties agree that the definition of Confidential Information in Clause 1.1 is amended by deleting the entirety of the final line of that definition and instead inserting the following at the end of the definition:
“Confidential Information does not include:
(f) Personal Information; and
(g) the terms of this Agreement.”
- Amendment to clause 4.5
The parties agree that clause 4.5 is amended by inserting the following after the word “value” at the end of the clause:
“it does not include the payment or reimbursement of any salary, wage, entitlement or expense in the usual and proper course of employment.”
- Amendments to clause 9
The parties agree that clause 9 is further amended by inserting the following clauses 9.7 and 9.8:
“9.7 Despite any Confidentiality or Intellectual Property right existing in the Agreement or a schedule, appendix or annexure to it, either party may publish all or any part of it without reference to the other.
9.8 Nothing in clause 9.7 derogates from a party’s obligations under the Privacy Act 1988 (Cwlth) or the Personal Information Protection Act 2004 (Tas)”.
Special Conditions
- Amendment to definition of Confidential Information
The parties agree that the definition of Confidential Information in Clause 1.1 is amended by deleting the entirety of the final line of that definition and instead inserting the following at the end of the definition:
“Confidential Information does not include:
(f) Personal Information; and
(g) the terms of this Agreement.”
- Amendment to clause 4.5
The parties agree that clause 4.5 is amended by inserting the following after the word “value” at the end of the clause:
“it does not include the payment or reimbursement of any salary, wage, entitlement or expense in the usual and proper course of employment.”
- Amendments to clause 9
The parties agree that clause 9 is further amended by inserting the following clauses 9.7 and 9.8:
“9.7 Despite any Confidentiality or Intellectual Property right existing in the Agreement or a schedule, appendix or annexure to it, either party may publish all or any part of it without reference to the other.
9.8 Nothing in clause 9.7 derogates from a party’s obligations under the Privacy Act 1988 (Cwlth) or the Personal Information Protection Act 2004 (Tas)”.
Treasurer's Instruction, Contracts – Disclosure and Confidentiality in Government Contracting
Treasurer’s Instruction, Contracts – Disclosure and Confidentiality in Government Contracting, issued under the Financial Management Act 2016 (Tas) (“TI C-1”) prohibits the inclusion of confidentiality provisions in contracts where the Tasmanian Crown is a party unless the Head of Agency (Secretary) grants approval.
- This prohibition applies only to the terms and conditions of the contract itself.
- The purpose of this policy is to not unduly fetter public scrutiny of contracts.
- Pursuant to Section 1.2 of TI C-1 a confidentiality provision may be sought by the Sponsor.
The Sponsor must make the application in writing to the Department of Health (Tasmania) requesting:
- the contract be confidential
- outline the sections of the contract that are to be made confidential
- or demonstrating that disclosure is commercially sensitive to the contracting party.
The request must be sent to:
- Dr Jodi Glading – Deputy Chief Medical Officer
- Email: [email protected]
Southern Eastern Border States (SEBS) panel
- The Southern Eastern Border States (SEBS) panel has representatives from the health departments of New South Wales, Queensland, South Australia, Tasmania, and Victoria.
- SEBS works to standardise (as far as possible) the terms and conditions of the Medicines Australia Clinical Trial Research Agreement (CTRAs) and Medical Technology Association of Australia Clinical Intervention Research Agreements (CIRA) to streamline the administrative management of contracts for Sponsors and public health service organisations who are parties to the agreements.
- The SEBS panel also considers proposed amendments and variations that are intended to accommodate, as far as possible, company-specific clauses that clarify or add to the CTRAs or CIRAs.
- The CTRAs or CIRAs can then be executed without the need for any amendments via Schedule 7 (or Schedule 4 in the case of the CRG, Phase IV CRO and Phase IV templates). This ensures national consistency and improves efficiencies on contract amendment negotiations.
- For further information or to submit an application for amendment, please visit the Medicines Australia website.
Non-standard research agreements
- Non-standard research agreements are not recommended for use within the Tasmanian public health services.
- If a Sponsor does not agree to use a standardised Medicines Australia CTRA or Medical Technology Association of Australia CIRA, the non-standard CTRA/CIRA must be forwarded by the RGO for review.
- If required, the RGO will seek further legal advice.
- The RGO will liaise with the Sponsor and Legal Services until agreement between the parties is reached.
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