Clinical trials determination guide

An applicant should first indicate the intention to rely on the determination at the question "What was the hypothesis?". An applicant should respond with:

• Covered by Industry Research and Development (clinical trials, Phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022. – RDTI D 2022/01. The CTA for the clinical trial or CTN registration number for the clinical trial is provided to demonstrate that a clinical trial is being conducted that meets the requirements of the determination. CTA No. is xxx OR CTN No. is xxx.

It's important that companies use the full name of the determination. 

Please note the CTA or CTN is provided to the company when the trial is registered with the TGA. This evidence of registration as well as evidence of payment of registration should be kept with other evidence of activities.

Applicants may also indicate an intention to use the determination at questions “A brief description of the activity" and/or “What new knowledge is this core activity intended to produce?”, if applicable (dependent on answering ‘Yes’ to question "Does this core activity commence after the end of your income period for this application?").  

For relevant questions after "What was the hypothesis?”, the applicant may use an abbreviated reference to the determination being relied upon: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.

• Question: "A brief description of the activity." Respond with: "Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "What new knowledge is this core activity intended to produce?" Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Did you conduct this core activity for a substantial purpose of generating new knowledge?" Select: “Yes”.
• Question: "What new knowledge was this core activity intended to produce?" Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "How did the company determine that the outcome could not be known in advance?" Select: “Other”.
• Question: "Please explain what sources were investigated, what information was found, and why a competent professional could not have known or determined the outcome in advance." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Please explain why the company did not search existing knowledge." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "What was the experiment and how did it test the hypothesis?" Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "How did you evaluate or plan to evaluate results from your experiment?" Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "If you reached conclusions from your experiments in the selected income period, describe those conclusions." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "What evidence did the company keep about this core activity?" Select: “Other” Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Please describe the other evidence." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.

An applicant should indicate the intention to rely on a determination at question “Describe the core R&D activity”, and respond with:

• Covered by Industry Research and Development (clinical trials, Phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022. – RDTI D 2022/01. The CTA for the clinical trial or CTN registration number for the clinical trial is provided to demonstrate that a clinical trial is being conducted that meets the requirements of the determination. CTA No. is xxx OR CTN No. is xxx.

For questions after this question, the applicant may use an abbreviated reference to the determination being relied upon: respond with “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.

• Question: "Describe the hypothesis." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Identify the experiment." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Explain the observation and evaluation." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Describe the logical conclusions to be drawn." Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Why do you consider that the outcome of this activity cannot be known or determined in advance?" Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.
• Question: "Describe the new knowledge the claimed core R&D activity is intended to generate". Respond with: “Relying on the R&D Tax Incentive determination 2022/01 on clinical trials”.

AOF applicants need to identify the ‘significant scientific link’ between the overseas activities and at least one Australian core activity. This is required to assess whether the overseas activities meet the expenditure test in s 28D(5) of the IR&D Act.

This should be done at the question, “Please describe the ‘significant scientific link’ between the overseas activities and the Australian core activity.” At this question, additional information will be required to describe the ‘significant scientific link’ between the overseas activities and the Australian core activity. In other words, explain why the Australian core activities could not be completed without the conduct of the overseas activity.

Please note when responding to questions that you will need to demonstrate that the expenditure condition at subsection 28D(5) of the IR&D Act has been met. 

AusIndustry may need to ask for more information about core R&D activities covered by the determination where meeting this condition is not sufficiently demonstrated in the application.