Department of medicine

Protocol Feasibility Assessment Checklist

1. Do you have the available patient pool to meet the elgibility criteria?*
2. Will you be able to enroll the target number within the enrollment period?*
3. Are the elgibility criteria realistic? (Consider screen failures. If you anticipate a very high screen failure rate, do you think you can meet the recruitment target?)*
4. Do you think you need help from physician colleagues to participate in screening for patients to meet the recruitment target?*
If so, have those colleagues agreed to participate?
5. Does this protocol involve recruiting vulnerable subjects?*
6. Are there any additional considerations for recruitment?*
7. Are there special requirements for storage of biological Samples?*
If you answered YES for question 7, can these storage needs be met?
8. Do you have reserach staff with the time to conduct this trial?*
9. Do you think you will need additional staff?*
10. Do you anticipate any IRB related issues with this protocol?*
If you answered YES to question 10, is there enough time for recruitment after the IRB approval process?

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