Does this study involve ANY of the following?

• Testing a drug, device, or biologic
• Pharmacovigilance study
• Interventional or surgical procedure
• Procedures, lab tests, or medical interventions that might be billed through UHealth or a commercial laboratory
• Prospectively assigns research subjects to one or more interventions
• Has a health-related biomedical or behavioral outcome
• Behavioral interventions, process of care changes, dietary changes, or physical therapy

Please check all that apply:

What is the overall study duration (ie., from screening of the first participant through the end of the last participant's follow-up period)? Provide years and months

Has the PI confirmed that the proposed enrollment numbers will guarantee authorship/co-authorship for UM?

Additional information on Authorship:

Based on information provided, the proposed enrollment number at UM is less than 10% of the study wide enrollment goal.

Please elaborate above on why/how the PI has confirmed authorship/co-authorship for UM with this low enrollment number. You may attach any documentation (e.g., email) between the PI and the Sponsor of the agreement confirming authorship/co-authorship.

Will this study compete with other active accruing research projects underway?

A competing trial will be a study that is for the same condition and with similar inclusion and exclusion criteria.

Will this study focus on an underserved or underrepresented population? 

Underserved would include disadvantaged populations with little to no access to healthcare such as homeless and/or populations with significant literacy, language, socioeconomic, mental, physical barriers to healthcare.

Underrepresented population refers to a subgroup of the population whose representation is disproportionately low relative to their numbers in the general population, or in the case of clinical trials or patient registries, disease population. The subgroups may be identified by race, ethnicity, age, sex, gender, socioeconomic status, etc.

Will this study serve a rare disease type (such as a disease that affects only a small percentage of the population and may be chronic, genetic, and/or lack effective treatment options)?

Feasibility Analysis:

Describe how you have verified that you have the patient population available to support research study objectives. 

This would include providing detailed information about the number of cases, clinic or hospital volumes, registry volumes or queries. 

Attach the feasibility check/query/report you have performed using existing tools (e.g., Oneness Research Solution (ORS), Slicer Dicer).

Helpful Resource: Research Feasibility Resources

If a detailed recruitment plan is available, please attach to this form.

Does the study require additional research assessments beyond standard of care such as patient reported outcomes, neurocognitive assessments, neuroimaging, clinical symptoms severity (clinician or self-reported), imaging, pathology services, and/or invasive procedures? Select "yes" if the study team will have to rely on and coordinate with health system or external collaborators to administer study requirements such as phantom (or "practice") scans, equipment certification, additional assessments, training or equipment.