Clinical Trial Research Agreement Request for Signature

Clinical Trial Research Agreements (CTRAs) must be established with the Institutions responsible for participating trial sites, documenting each party's obligations for the conduct of the trial and outlining any payments that will be made to the site.

CTRAs for Clinical Trials where UNSW is the trial sponsor must be submitted clinicaltrials@unsw.edu.au. As the UNSW Sponsors Delegate, Dr Ted Rohr is the signatory for these UNSW sponsored Clinical Trials.

CTRAs for Clinical Research Studies or Commercially Sponsored Clinical Trials must be submitted to Research Grants and Contracts. Debbie Docherty, Director RGC, is the signatory for these agreements.

Clinical Trial Research Agreement Signature Request Requirements

The following steps must be completed before CTRAs are submitted for signing.

The UNSW sponsor responsibilities or the Kirby Institute requirements have been completed.
HREC approval has been obtained, and if approved elsewhere, the external ethics approval submission process is completed.
Insurance coverage for the study is obtained.

Submission Instructions

Follow the Clinical Trials Research Agreement and Indemnity Form Submission Checklist.
Draft Clinical Trial Research Agreements and Indemnity Forms using the Medicines Australia templates in word format.
Attach email evidence of the Coordinating Principal Investigator following the instructions in the above Clinical Trial Research Agreement and Indemnity Form Submission Checklist.
Attach and send all documents in an email to clinialtrials@unsw.edu.au.

UNSW Legal Review – Medicines Australia Clinical Trial Research Agreement Templates

Changes to clauses 1-27 of the CTRA require additional legal review. The Clinical Trials Governance Office will arrange a legal review. In addition, researchers must draft the proposed changes to schedule 4 in the Medicines Australia Collaborative Research Group Clinical Trial Research Agreement.

Draft CTRAs must be sent to clinicaltrials@unsw.edu.au.The Clinical Trials Governance Officer will copy the Research Team on all correspondence relating to Schedule 4 Legal Review.

UNSW Legal Review – Non-Standard or International Clinical Trial Research Agreements

Non-standard and International Clinical Trial Research Agreements require additional legal review. The Clinical Trials Governance Office will arrange a legal review. Researchers must draft or provide the proposed agreement and submit it via email to clinicaltrials@unsw.edu.au.

The Clinical Trials Governance Officer will copy the Research Team on all correspondence relating to the Legal Review of non-standard or international agreements.

Note: Any clinical trial research agreements not submitted using the Medicines Australia templates are considered Non-standard clinical trial research agreements.

Submission Closing Dates

Closing dates do not apply to this process. Submissions to request confirmation of sponsor responsibilities can be sent as required.

Timeframe for Review

Researchers should allow up to 5 working days to receive outcomes.

Research Agreements for Clinical Research

Clinical Trial Research Agreements for research that does not meet the definition of a clinical trial specified below must be submitted to the Research Grants and Contracts Office for signing. It is recommended that the Medicines Australia Clinical Trial Research Agreement template is used for these research studies.

Clinical Trial Definition: At UNSW, Clinical Trials are defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions (which may include placebo or other control) where the primary aim of the research is to evaluate the effect of the intervention on health outcomes. The Clinical Trial Decision Tool can assist researchers in determining whether the research meets the definition of a clinical trial.