IMPACT Application trial endorsement

IMPACT application for trial endorsement

Trial protocol:*

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Single-page synopsis of the trial:*

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Declaration of any relevant potential conflicts of interest of IMPACT Network committee members:*

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Evidence of trial feasibility, including proposed budget, funding strategy and/or a demonstration of in-principle support from sites:*

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Date of submission*

Full trial title*

Simplified title*

Trial acronym*

Name of Chief Investigator:*

Prefix (optional)

First Name

Last Name

Phone*

Email*

Administering Institution*

Trial steering Committee member names*

What issue of major importance does the study address? Please provide a brief summary of the recognised knowledge gap including reference to all relevant systematic reviews*

Has there been a budget impact analysis that shows the expected impact of the study on the health care budget in terms of the prevalence of disease in Australia/NZ, the number of interventions and the health care costs that are involved?*

Yes No

If not, is this planned?*

Is the trial multi or single-centre?*

multi-centre single-centre

What sites will be involved and who will be the lead investigators at each site?*

Has the study been granted ethical approval?*

Yes No

Please provide approval number*

Please detail plans for approval*

Is the protocol registered in a clinical trials register?*

Yes No

Please provide Registry Number*

In which register is it intended to be submitted and when?*

Has recruitment commenced?*

Yes No

Does the trial steering committee include at least one member who has experience in completing a multicentre collaborative study? Please explain briefly*

What engagement has there been with the IMPACT network with respect to this trial to date? If the trial has been presented at an IMPACT workshop, please provide dates.*

Please briefly explain how an appropriate consumer group has been included and their feedback incorporated into trial design?*

Notes/Comments