SITU Expression of Interest Form

Your name

Your E-Mail Address

Your phone number

Are you the proposed CI?

Yes

No

If no, please provide the name of your CI

Trial title

Short proposal title

Phase of trial

Phase I

Phase II

Phase III

Phase IV

Please select which one of these categories describes your research (as per IRAS definitions)

Collaborators and their associate department/institution – Is this a UK only or international study?

Surgical specialty/area of research

At what stage of the development is the proposed trial?

Embryonic idea

Proposal in development

Funding application submitted

Funded study

Has funding been applied for?

Yes

No

If yes, please provide details e.g. funder, funding call deadline

Will this study involve the use of any medical device without a CE mark, or a CE marked device which has been modified or will be used outside its intended purposes?

Yes

No

Is this trial subject to advice from the Expert Advisory Group on Clinical Trials and the Commission on Human Medicine prior to authorisation from the MHRA?

Yes

No

Unsure

Is this a trial of a gene therapy medicinal product?

Yes

No

What is the primary research question and please give a synopsis of the study?

If this is an RCT, please consult the SPIRIT guidelines for preparing your study protocol and address as many of these items as possible with your expression of interest. Please describe your research question in terms of the PICO structure (Population, Intervention, Comparator,Outcome measures (efficacy and harms) and for each of these explain their rationale. You should be aware of any ongoing RCTs aiming to address this or similar question/s. Check trial registers such as clinicaltrials.gov/ISRCTN Your trial might not be quite ready for an RCT, if so, please identify at what stage pre-RCT you are at. If you are developing a new surgical technique or evaluating a new device please consult the IDEAL Framework (www.ideal-collaboration.net/) and see attached summary to identify stage of development and appropriate methodology.

What is the clinical question and the anticipated clinical impact of the question?

Primary Outcomes (can be TBC)

Secondary Outcomes (can be TBC)

Estimated number of subjects (can be TBC)

Estimated number of centres (can be TBC)

What would you like our input on?

Sponsor

Please be aware that the Sponsor is usually the employer of the Chief-Investigator

Proposed grant/study start date

/ /

Proposed grant duration (years)

I understand and am in agreement with the disclaimer laid out below

The information that I submit will be sent via email to a secure mailbox, where it will be passed on to the appropriate individuals.This includes but is not restricted to members of the SITU Executive Committee and the SITU Administrator. The information will be treated as confidential and will not be passed on to any third parties. I understand that if I wish to withdraw my submission at any point I must contact the SITU Administrator at situ@nds.ox.ac.uk

Yes

No

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SITU Expression of Interest Form