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 firstname.lastname@example.org. 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.
The following steps must be completed before CTRAs are submitted for signing.
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 email@example.com.The Clinical Trials Governance Officer will copy the Research Team on all correspondence relating to Schedule 4 Legal Review.
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 firstname.lastname@example.org.
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.
- Closing dates do not apply to this process. Submissions to request confirmation of sponsor responsibilities can be sent as required.
- Researchers should allow up to 5 working days to receive outcomes.
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.