2021 International Clinical Trial Collaborations – Round 1

TIMELINE

ASAP

Notice of Intent (NOI) registration open

10am, Monday 9 August 2021

Optional but highly encouraged: Work in Progress Grant Proposal due to RIC for review and advice

10am, Monday 23 August 2021

Draft application due to RIC for strategic review and compliance and eligibility check (including other supporting documents, if applicable)

5pm, Wednesday 25 August 2021

Minimum Data closes on Sapphire

10am, Monday 6 September 2021

Final application and Authority to Submit (ATS) Form submitted to RIC

5pm, Wednesday 8 September 2021

Final application submitted to NHMRC

Overview

The objective of this International Clinical Trails Collaboration - Round 1 Grant Opportunity (GO ID: GO4722) is to provide financial assistance to support Australian medical research and medical innovation projects that:

  • utilise clinical trials to promote Australian involvement in international collaborative investigator-initiated clinical trials research through the establishment and co-ordination of clinical trial site/s in Australia.
  • provide high-quality evidence of the effectiveness of novel health treatments, drugs or devices in ‘usual care’ settings, which will support a decision on whether to deliver the intervention in an Australian setting. Novel health treatments include new and innovative applications of existing interventions.

To be competitive for funding, applicants must propose to conduct research that delivers against the above objective and those of the Clinical Trials Activity - International Clinical Trial Collaborations Initiative.

Requirements: Applications must propose a single clinical trial in Australia in collaboration with international counterparts. The clinical trial should not have commenced recruitment at the Australian trial site/s.

International collaboration: Applications where international collaboration provides for the successful conduct of clinical trials that may otherwise not be feasible in Australia are particularly encouraged (for example, due to low prevalence in the Australian population or because a large scale is required to identify meaningful effect differences).

In such circumstances applicants must demonstrate how the benefits of international collaboration will be utilised: it is reasonably expected that the total number of participants will be at least double that recruited via the Australian clinical trial sites.

Encouraged applications: Applications that utilise novel and innovative clinical trial methodologies and/or utilise the capabilities of established clinical quality registries are also encouraged.

Round 2

This Grant Opportunity consists of two Rounds (review cycles). The key dates for Round 2 are:

  • Applications Open: Thursday 26 August 2021
  • Minimum Data: 5pm, Wednesday 2 February 2022
  • Application deadline to NHMRC: 5pm, Wednesday 16 February 2022

Grant Amount and Grant Period

  • Up to $6.3 million of funding is available in this round in 2021 - 22
  • There is no maximum grant amount but grants cannot exceed the amount of available funds
  • The maximum project period is five (5) years
2021 - 22022 - 232023 - 242024 - 252025 - 6
$6.3 million $0 $0$0$0

Eligibility

  • A person must not be named as a Chief Investigator (CI) on more than one application submitted to a Round of this Grant Opportunity.
  • It is generally required that, at the time of application submission, the CIA is an Australian citizen or is a permanent resident in Australia (see also section 6.4 of the Guidelines). The research proposal must involve the CIA being based in Australia for the duration of the grant.
  • The proposed research duplicates research previously or currently being undertaken. We may compare the research proposed in grant applications with grants previously or currently funded by the MRFF, NHMRC or other agencies (e.g. Australian Research Council) and published research (see also sections 4.7, 7.2 and 7.3 of the Guidelines)

How to apply

  1. Notice of Intent

    Please register your Notice of Intent if you are considering applying for the this Grant Opportunity.  RIC-MRFF team will then contact each applicant with further information.

  2. Update/complete Sapphire Profile

    Each Chief Investigator (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 documentation

    Review the grant guidelines and category descriptors available below and at Grant Connect (GO ID: GO4722)

  4. Create and Complete the application

    Log in to Sapphire, select the relevant Grant Opportunity to complete the application

  5. Submit “Review Ready” application to RIC

    Submit application to RIC within the RIC internal submission period(s) for review(s)

  6. Complete application

    Taking feedback from the RIC team into consideration, complete the application in Sapphire. It is suggested advice is sought from colleagues, Faculty Mentors, etc. before finalising the application.

  7. Submit the UoM Authority to Submit Form

    This form must be submitted to RIC electronically by the final internal closing date. The form should include:

    • The CIA and all 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.

    This is an NHMRC requirement and the application cannot be submitted to NHMRC until received.

  8. Final Submission

    On the final internal closing date, the applicant must:

    • 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.
    • Email RIC enquiries-mrff@unimelb.edu.au Include the completed scanned and signed Authority to Submit form.
    • Should you require further information please contact the MRFF team via enquiries-mrff@unimelb.edu.au
  9. RIC will submit the application

    Once the application has been submitted to NHMRC, you will receive an email from RIC confirming submission.

Key Contacts

Contact
Jasmine Lim
Email
enquiries-mrff@unimelb.edu.au
Phone
T: +61 3 9035 6615