On this page

R&D Tax Incentive determinations are notifiable instruments that set out how the law is interpreted and applied when administering the R&D Tax Incentive program. When a determination is in force it is binding on Industry Innovation and Science Australia and its delegates except in certain circumstances, such as during a review of a reviewable decision. If an application or registration is examined, any applicable determinations will be applied.

View the determination on the Federal Register of Legislation.

Background to this determination

Clinical trials require careful planning, monitoring and regulatory oversight to minimise risks. Activities involved in clinical trials that are covered by this determination are deemed to meet the requirements of the R&D Tax Incentive for being ‘core R&D activities’. That is, the outcome of clinical trial activities covered by this determination cannot be known or determined in advance and can only be determined by applying a systematic progression of work, and that clinical trials covered by the determination are conducted for the purpose of generating new knowledge.

This determination was developed in consultation with the Australian Taxation Office, the Department of Health and through public consultation. It was approved by Industry Innovation and Science Australia and came into effect on 1 April 2022.

This clinical trials determination simplifies application to the R&D Tax Incentive program and provides certainty for companies whose activities fall within the scope of the determination.

Using the determination when you register

The determination can be used by companies conducting clinical trials when applying to register those activities under the R&D Tax Incentive program and describing ‘core R&D activities’.

An applicant should first indicate the intention to rely on the determination at question 76 “Is this core R&D activity covered by an Industry Research and Development Determination?".

An applicant should respond with: Yes

In the subsequent question 77 “Which determination are you relying on?” an applicant should respond with:

  • “R&D Tax Incentive determinations are notifiable instruments that set out how the law is interpreted and applied when administering the R&D Tax Incentive program. When a determination is in force, it is binding on Industry Innovation and Science Australia and its delegates except in certain circumstances, such as during a review of a reviewable decision. If an application or registration is examined, any applicable determinations will be applied.

    Covered by Industry Research and Development (Clinical Trials) 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.”

Please note: You need to insert your trial’s particular CTA or CTN number to replace the XXX in your response at “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 are also advised to use the determination at the below mentioned subsequent questions:

  • Question 76 “Is this core R&D activity covered by an Industry Research and Development Determination?”

    Respond with: Yes
  • Question 77 “How did the company determine that the outcome could not be known in advance?”

    Respond with: Other
  • Question 78: “How did the company determine that the outcome could not be known in advance?”

    Select: Other
  • Question 88: “Did you conduct this core R&D activity for a purpose of generating new knowledge?”

    Select: Yes

For the following questions, the applicant may use the response below.

  • Question 79: “Please explain what sources were investigated and what information was found.”
  • Question 80: “Why couldn’t a competent professional have known or determined the outcome in advance?”
  • Question 82: “What is the hypothesis?”
  • Question 83: “What is the experiment and how will it/did it test the hypothesis?”
  • Question 84: “How did you evaluate or plan to evaluate results from your experiment?”
  • Question 85: “If you reached conclusions from your experiments in the selected income period, describe those conclusions.”
  • Question 89: “What new knowledge was/will this core R&D activity (be) intended to produce?”

Respond with:

  • “R&D Tax Incentive determinations are notifiable instruments that set out how the law is interpreted and applied when administering the R&D Tax Incentive program. When a determination is in force, it is binding on Industry Innovation and Science Australia and its delegates except in certain circumstances, such as during a review of a reviewable decision. If an application or registration is examined, any applicable determinations will be applied.

    Covered by Industry Research and Development (Clinical Trials) 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.”

Using the determination when applying for an advance or overseas finding (AOF)

Some organisations apply for AOFs to seek certainty about whether their activities are core R&D activities before they register.

Please note: For AOF applications, the determination can only be used if all parts of the core R&D activity are occurring solely in Australia. If any part of the activity occurs overseas; e.g., if the evaluation or conclusions are sent to a parent company overseas, then the activity will not be deemed to be an Australian core activity.

An applicant should indicate the intention to rely on a determination at question 84 “Describe the core R&D activity”, and respond with:

  • “Covered by Industry Research and Development (Clinical Trials) 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.”

Please note: You need to insert your trial’s particular CTA or CTN number to replace the XXX in your response at “CTA No. is xxx OR CTN No. is xxx.”

For the following questions, the applicant may use the response below.

  • Question 92: "How did the company determine that the outcome could not be known in advance?"
  • Question 96: "What is the hypothesis?"
  • Question 97: "What is the experiment and how will it test the hypothesis?"
  • Question 98: "How do you plan to evaluate results from your experiment?"
  • Question 99: "Describe the logical conclusions to be drawn."
  • Question 104: "What new knowledge is this core R&D activity intended to produce?"

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.

  • Question 107 “Please describe the ‘significant scientific link’ between the overseas activities and the Australian core activity.”

    Respond with: additional information to describe the ‘significant scientific link’ between the overseas activities and the Australian core activity. 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.

We 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.

Exclusions and R&D not covered by the determination

As some clinical trials do not involve an unknown outcome and/or they involve commercialisation activities, they are not covered by this determination.

Activities not covered by the determination may still be a core R&D activities. An R&D entity will need to demonstrate that those activities meet the criteria independently, without the support of this instrument.