NHMRC Clinical Trial and Cohort Studies (CTCS) Grants – Now Open

The NHMRC Clinical Trial and Cohort Studies (CTCS) Grants scheme is now open for applications in Sapphire. The objective of the CTCS Grant scheme 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.

This grant opportunity is open to research proposals for clinical trials and/or cohort studies of any size – that is, they may be large or small clinical trials or cohort studies.

Grant Guidelines and Grant Proposal Documents - Available on GrantConnect
Grant Guidelines and the Grant Proposal template are available on GrantConnect (GO3714). You will need to login to access the documents. MRO Submission Process Document are available on the Intranet page.

Definition of Clinical Trials and Cohort Studies
The Clinical Trial and Cohort Studies Grants 2020 Guidelines (the Grant Guidelines) have provided the following definitions for clinical trials and cohort studies:

Clinical Trial: High-quality clinical trials provide reliable evidence of the effects of health related interventions on health outcomes (or appropriate surrogates). This means that:

• The project must involve human participants
• The participants are prospectively assigned to one or more interventions
• The effects of the intervention(s) on the participants will be examined, and
• The anticipated effects of the intervention will be a behavioural and/or health-related outcome.

Cohort Study: High quality cohort studies provide reliable evidence on the relation of important risk factors and other exposures to health-related outcomes. This means that:

• The project must involve human participants
• The participants are prospectively followed over a defined period of time, and
• The project aims to evaluate associations between one or more factors in the cohort with a behavioural and/or health related outcome.

The 2020 Clinical Trials and Cohort Studies 2020 Grant Guidelines has also included the following definition of a retrospective cohort study.

Retrospective cohort studies provide reliable evidence on the relation of important risk factors and other exposures to health-related outcomes. This means that:

• The project will involve human participants
• The project will collect and examine retrospective data and may involve some elements of data linkage work, and
• The project aims to evaluate associations between one or more factors in the cohort and a behavioural and/or health-related outcome.

Minimum Data
Ideas Grants have a minimum data requirement. Minimum data must be entered into Sapphire by 17:00 AEST 1 April 2020. Applications that fail to satisfy this requirement will not be accepted. Minimum data for CTCS Grants is comprised of:

• Application title
• Administering institution
• Aboriginal and/or Torres Strait Islander Health Research Focus (yes/no)
• Project synopsis
• Privacy agreement
• Research Classification:
• Broad research area
• Field of research
• Peer Review Areas
• Research keywords
• Chief Investigator A (complete CIA Role and Name )

The MRO will automatically begin checking applications to ensure they meet minimum data requirements in Sapphire from Wednesday 25 March 2020 and will contact you if there are missing sections. You do not need to contact us to request we check your minimum data.

MRO Compliance & Eligibility Checking & Webinar
As required for submission, the MRO will be conducting eligibility and compliance checks of CTCS Grant applications. The due date for a full draft to be provided to MRO (including Sapphire sections being completed with a justified budget, and the Grant Proposal document) is 1 April 2020. Due to the Easter and Anzac Days public holidays, only applications that meet the 1 April 2020 deadline will have a full check of the application.

The MRO will be holding a webinar on Friday 6th March 2020 at 1-2pm to discuss the major guidelines and requirements for CTCS Grants.

• To join from a PC, Mac, iPad or Android device: click on https://monash.zoom.us/j/260543638 or, go to https://monash.zoom.us/join and enter meeting ID: 260 543 638  
• To join from a dial-in phone: dial: +61 3 9905 9666 (+61 3 9905 ZOOM) or +61 2 8015 2088 (meeting ID: 260 543 638). 

Key Dates
Applications open in Sapphire: 4 March 2020
Minimum data close: 1 April 2020
MRO Compliance Check close: 1 April 2020 (for a full eligibility and compliance check)
CI Certification of Finalised application: 24 April 2020
NHMRC external deadline: 29 April 2020

Please contact the MHS team if you have any questions.