The code block below illustrates how one might use # and // as comments in your logic and calculations.

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Study Feasibility Form

Please complete the survey below to start the feasability process for your study. Please contact Nadine Obeid (nadine.obeid@bcm.ed) should you have any questions,

Thank you!

Pediatric Rheumatology Team

Principle Investigator

E-mail

* must provide value

Title of Study

Brief Summary of Trial/Study (Please write a couple sentences summarizing study)

Sponsor Due Date

Project Start Date

Yes

N/A

Are there any competing trials ongoing within the division?

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If so, will there be a sufficient number of eligible participants for the trial?

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Is there a plan to avoid research burden for the eligible participants?

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If unsure of the potential subject population, have you searched database or medical coding lists to determine the number of patients seen at site with a specific diagnosis code?

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Are the inclusion and exclusion criteria realistic? Are items too restrictive?

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Are there extenuating circumstances that would adversely affect recruitment? - i.e. Traditional treatment becoming approved as over the counter?

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Are Biosamples needed? (specify number of patients or # of samples in comment field below)

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Will the biosamples require lab processing?

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Can enrollment goals/milestones be met? Specify number of participants/timeframe in the comment section below.

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Estimated number of subjects enrolled per year

Comments

Yes

N/A

Are ancillary or specialty staff needed (pharmacy, labs, diagnostics, etc.)? Please designate in comments section below.

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Are there adequate sub-investigators to assist PI with the trial?

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If needed, is training available? (protocol and data training)

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Is the workload manageable? (ie time spent on data entry, number of participants etc)

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Does the PI have adequate time to devote to the protocol?

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Are study visits complex, presenting possible scheduling difficulties? (ie Are study visits separate from standard of care?)

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Have you reviewed the case report forms (CRFs) and patient questionnaires, if available, and time required to complete assessed?

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What type of research staff are required for the research? Check all that apply.

Regulatory Coordinator (IRB help)

Research Coordinator (Consenting, data/sample collection)

Statistician

Research Administrator (funding)

Do you require IRB submission assistance?

Yes

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If you need IRB assistance, what type of IRB submission is required?

Reliance on External IRB

Internal IRB

N/A

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Full protocol available? Please upload.

Upload file

Comments

Yes

N/A

Will the sponsor supply (CRFs, source documents, electronic consent template, packaged lab kits, pre-paid shipping, etc.)? Upload protocol documents below.

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Will electronic or remote data capture be used? If so, will sponsor provide hardware and training?

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CRFs/Patient Questionnaires Available? If so, please upload them here.

Upload file

Comments

Is there funding available? If yes, what type of funding?

Cash Award

Per Subject

Per Milestone

N/A

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Was budget provided? If so, upload here

Upload file

Do we get paid for PI effort/RC effort?

Only PI effort

Only RC effort

Both PI and RC effort

N/A

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Is this a sub-award? If yes, specify funding institution here. (if no, type N/A)

Please specify any deadlines coming up. If none, type N/A

Will research lead to PI or Co-PI academic work products?

Yes

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If yes, please specify academic work product

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