Device Trial (IDE)Submission for Full FAP Review is required for any clinical trial/research project that includes clinical activities that may be provided and billed by a UAB Health System entity.1. Email submission to FAP@uab.edu. Submission must include:
a. Completed CBR Submission Form
b. Study protocol, or UAB IRB Human Subjects Protocol (HSP) if a protocol is not available
c. Draft consent form(s)
d. Departmental bill-to-designation (see marked protocol schema exampleor excel format) including specific location of service for device implantation. Indicate if inpatient or bedded outpatient admission. Include provisions for device and cost to hospital if applicable.
e. A copy of the department of Health and Human Services (FDA) memo indicating reimbursement category (A or B).
f. Reimbursement manual (if available)
g. Draft clincial trial agreement
h. Sponsor draft budget or relevant grant/contract budget information, and/or
i. Instructions for additional device trial requirements
j. Submission Form Hospital Review of Device Trials
k. Product Review Requestor Form should be completed if Health System is purchasing new device or supplies
l. UAB Hospital Equipment and Supplies Agreement Template if appropriate
m. If applicable, the following completed forms must also be submitted:
i. Radiology Research Quote Request form, and/or
i. If applicable and when available, submit the following:
NOTE: If research activities are to be provided by an Ancillary Research Area that bills for their services internally department to department (and therefore no billing through a UAB Health System entity), submission to the Ancillary Research Area concurrent with FAP submission is encouraged. For example, if planning to use Tissue Procurement, Dermatology research, or Ophthalmology research services, departments must submit separately to those areas in order to obtain fees for their services.