Clinical Trials and Cohort Studies Grants

Overview

NEW! NHMRC has updated the Direct Research Cost (DRC) Guidelines and the 2024 Personnel and Salary Support Package rates for funding commencing in 2025.

The Clinical Trials and Cohort Studies Grants opportunity is to support high-quality clinical trials and cohort studies that address important gaps in knowledge, leading to relevant and implementable findings for the benefit of human health.

The desired outcomes of the Clinical Trials and Cohort Studies Grant opportunity are the improvements in health and wellbeing, health care practice or policy, as a result of;

• High-quality clinical trials that provide reliable evidence of the effects of health-related interventions on health outcomes (or appropriate surrogates), and/or
• High-quality cohort studies that provide reliable evidence on the relation of important risk factors and other exposures to health-related outcomes.
• High-quality retrospective cohort studies that provide reliable evidence on the relation of important risk factors and other exposures to health-related outcomes.

Only applications that will deliver against the intended objective and outcomes will be competitive for funding.

Examples of research that are not considered relevant to the desired outcomes include, but are not limited to:

• Laboratory-based research, including research based on animal models or other pre-clinical studies, and
• Mechanistic studies that are not clinical trials or cohort studies

Applicants seeking funding for these types of research should consider other grant opportunities, such as NHMRC’s Ideas Grant Scheme.

A Clinical Trials and Cohort Studies Grant can be requested for between one and five years depending on the proposal and the maximum number of Chief Investigators (CIs) allowed on an Ideas Grant application is 10 (CIA - CIJ). The amount of funding for a Clinical Trials and Cohort Studies Grant will be based on assessment of the requested budget.

Please note that all NHMRC documentation relating to this scheme can be found via GrantConnect. If you don't already have one, you will need to create login details for Grant Connect.

Further information and changes relating to this scheme can be found on the NHMRC Website.

How to apply

Steps to be completed by Chief Investigator A (CIA):

1. Submit a Notice of Intent (NOI)

The NOI should be completed early to provide RIC with CIA contact details.

2. Complete/update Sapphire Profile and CV details

Each CI will need to obtain access to the Sapphire to complete this step. Applicants (including all Chief Investigators and Associate Investigators) are required to submit a registration form available on the Sapphire Landing Page. NHMRC copied RGMS users’ CV/Profile data from RGMS for migration into Sapphire on Wednesday 12 February 2020 after 5.00pm (AEDT). Any changes made to an RGMS profile after this date have not been replicated in Sapphire.

3. Review the funding documents

The CIA should read the NHMRC Guidelines (Grant Connect GO6323) to Applicants.

4. Complete draft application

Complete the draft application in the Sapphire Grant Management system.

5. Email a draft application to RIC

Send a draft Grant Proposal and application preview to RIC via email nhmrc-project@unimelb.edu.au for review. A hardcopy is not required. To obtain your Sapphire application preview documents, click the "Preview" button on the top right corner and a zip folder consisting of the preview documents will be downloaded automatically.

6. Complete the application after feedback

After taking feedback from RIC into consideration, complete the application in the Grant management system. Upload all documents and referee reports as outlined in Guideline to Applicants, paying special attention to formatting requirements. It is suggested to seek advice from colleagues, Faculty Mentors, etc. before finalising the application.

7. Certify the application in the Grant management system

Certify the application via the ‘Certification’ function in the left panel of your Sapphire application. The applicant will be given the opportunity to download their application and attachments prior to the two-stage confirmation prompt before submission. The application will be locked once certified and status then will be Submitted to RAO.

***Please note that we have observed delays within Sapphire where the approvals tab to submit applications is taking ~15 minutes to load, as such there is a risk to the timely submission of your application if it is received after the RIC Final Submission Deadline. To minimise any delays or issues with the submission of your application we advise adhering to the RIC final submission deadline for this scheme.***

8. Submit the UOM Authority to Submit form

Submit a UOM Authority-to-Submit form (DOCX 131.2 KB) in one pdf document to RIC via email nhmrc-project@unimelb.edu.au before 10:00 am on the final internal closing date, Monday 21 August. The form should include:

• CIA signature
• Head of Department/Institute Director signatures

Written evidence (e.g. email) from all CIs and AIs is no longer required for applications submitted via Sapphire. Accepting an invitation to participate in an application constitutes a written agreement to be named on an application. CIAs cannot submit an application for RAO certification until all research team members on their application have accepted the invitation.

A hardcopy of the Grant management system application is not required.

Note that this is an NHMRC requirement and the application cannot be submitted to NHMRC until RIC receives this form.

9. RIC will submit the application

RIC will submit the application to NHMRC and the CIA will receive Sapphire notification when this has been done.

Supporting documents

NHMRC Documentation

All NHMRC documentation relating to this scheme including scheme guidelines and the grant proposal template can be found via Grant Connect.

• Updated Direct Research Costs (DRC) Guidelines
• Updated Personnel and Salary Support Package rates for funding commencing in 2025

RIC Documents

• UoM Authority to Submit Form
• Copies of previous successful CTCS Grant applications held in the RIC Successful Grants Library

Seminars and Workshops

RIC hosted a webinar on the NHMRC CTCS 2023 scheme for funding in 2024 at 11am on Friday the 14th of July 2023, including an overview of the scheme, key changes in the funding rules and an overview of the application process. Slides (PDF 2.1 MB) and a video recording of the 2023 CTCS Grant scheme information session are available. Also see the MDHS Townhall Slides.

For detailed advice on completing NHMRC budgets, including eligible/ineligible funding requests and best practice for justifying each budget item, please see the RIC NHMRC Ideas Grant Budget Info Session .

Sapphire Resources

• Sapphire Landing page
• FAQs
• Tutorial videos

NHMRC Open Access Policy

From 1 January 2024, all NHMRC grant holders must comply with NHMRC’s Open Access Policy. The policy requires full and immediate open access for NHMRC-funded research outputs.

For more information on how to comply refer to the UoM webpage on funder open access policies.

NHMRC policy on use of generative artificial intelligence in grant applications

NHMRC has released some key advice regarding the use of generative artificial intelligence (AI) in grant application and peer review. Please refer to the NHMRC policy page and note the following:

• Application drafting Information provided to generative artificial intelligence (such as natural language processing models and artificial intelligence technology tools) becomes part of a public database and may be accessed by unspecified third parties. If you use generative artificial intelligence to assist with the drafting of your application, you must ensure you are aware of the potential risks involved, such as those related to security, confidentiality, intellectual property, privacy, the accuracy of information generated and possible plagiarism.
• Peer review Use of generative artificial intelligence in peer review Information provided to generative artificial intelligence (such as natural language processing models and artificial intelligence technology tools) becomes part of a public database and may be accessed by third parties. Peer reviewers must not input any part of a grant application, or any information from a grant application, into a natural language processing and/or artificial intelligence technology system to assist them in the assessment of applications. Use of generative artificial intelligence may compromise the integrity of NHMRC’s peer review process and be in breach of its Principles of Peer Review, the Australian Code for the Responsible Conduct of Research and the confidentiality undertaking of peer reviewers.

Other Resources

Applicants to this grant scheme will be asked to demonstrate that there is a strong rationale for this work. This may include a request to describe what previous research has occurred and to described a systematic review or literature review. The following sites are useful for identifying systematic reviews:

• Epistemonikos
• Trip Database
• Cochrane Library
• JBI Database of Systematic Reviews and Implementation Reports
• PubMed Clinical queries
• Methods and Implementation Support for Clinical and Health Research

Cancer Australia - PdCCRS

Cancer Australia (CA) funding can be sought through both NHMRC Clinical Trial and Cohort Studies (CTCS) or NHMRC Ideas Grant applications.

Applicants are required to submit two documents in addition to the NHMRC CTCS application on Sapphire:

1. A 1-page modified research proposal included in Section I of the Grant Proposal document with reduced aims and timeframes as part of their Grant Proposal, if the amount of funding or the duration of funding exceeds the limitations imposed by Cancer Australia’s relevant PdCCRS grant category A.
2. Cancer Australia applicants are also required to complete the PdCCRS Questions form for the relevant Research Priority Area.

Applicants must meet Minimum Data and meet application deadlines for the NHMRC CTCS grants schemes.

Please ensure both documents are provided to RIC for review at the same time as your NHMRC CTCS application.

In addition, applicants must submit the final Cancer Australia PdCCRS questions document to nhmrc-project@unimelb.edu.au before the due date for submission to Cancer Australia.

Refer to Grant Connect (GO6323) for Application Guidelines and Application Forms for PdCCRS Standard and Early Career Research Grants in the General Cancer Research Priorities.

Contacts

Manage Your Grant