University of Tennessee College of Medicine

OF 2 University Of Tennessee College Of Medicine Research Proposal Check Sheet (This form must be used for all requests submitted to the IRB)

Name of Investigator: Telephone Fax Co-Investigators: Contact Person: E-mail Address:

Key Personnel:

IRB Tracking Number:

Title of Research:

A copy of all documents listed must be Attached to the IRB Request Form and included in the IRB Submission Packet for each type of Research Review. (Must be submitted at least 21 days prior to the upcoming meeting) Please remember that a $1800 fee form full board review is charged for industry-sponsored studies, there is a $500 fee for expedited review of new industry sponsored studies. You must make sure this is negotiated in the Research Contracts.

Initial Approval Request For Expedited or Full Board (Form A) - (Attach a copy of each item listed below)

YES NO N/A Research Protocol

Protocol Synopsis (See Instructions for Initial Approval Request)

Investigator Brochure

Consent Document completed with Erlanger Health System required information (see attached model consent)

Medicare Coverage Analysis and proof of standard of care procedures for disease type/treatment(Must be completed and approved by local Medicare provider prior to IRB review)

Clinical Research Billing Form (This form must be completed and faxed to registration, and emailed to Alicia Songer and the IRB office once a patient is enrolled in a clinical research study.)

Research Contract and Budget or Grant Application (The IRB reviews contracts and budgets for Conflict of Interest Issues. At least a Draft copy must be received before the study will be reviewed.

(If through UT - Research Contracts must be submitted to Debbie Smith at UT Memphis, following signatures from the Dean’s office, prior to submission for IRB approval.

Study Budget including a separate matrix of services needed and payment amounts per protocol requirements if Erlanger will be providing services outside the standard of care.

Principal and Co-Investigator’s CV (if already on file, only send if updated)

Copy of CITI Human Subjects Protection Education Certification, if not already on file (must be completed before study will be reviewed)

Completed 1572 Form (This form is required for FDA regulated investigational drug studies)

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Exempt Proposal Requests ( Form B Or H) (Attach a copy of each item listed below)

YES NO N/A Form B Request for Exemption Form H Waiver of Authorization (for retrospective chart review or single case reports) Data Query Request Form (for retrospective chart review) Detailed Research Protocol

Revisions/Changes to Currently Approved Research (Form C) (Attach a copy of each item listed below) YES NO N/A Revised Research Protocol Revised Consent Document completed with UT/Erlanger Health System required information (see attached model consent) Current Approved Stamped Consent Synopsis of Changes Revised Investigator Brochure

Continuing Review Requests (Form D) (Attach a copy of each item listed below) YES NO N/A List of All Patients enrolled since last approval period and a copy of the signed signature page for each patient List of Patients remaining in follow-up. List of All SAE/Deaths that have occurred onsite or in patients enrolled through this site since the last approval period. List of All SAE/Deaths that have occurred onsite or in patients enrolled in the study since the last approval period (SAE’s from sponsor or other sites) A Copy of the current approved consent form (stamped version) Clean Copy of current consent form to be stamped A Brief summary of the results of the study to date

Unexpected Adverse Event/SAE (Form E) (Attach a copy of each item listed below) YES NO N/A Detailed description of SAE/Death including Medical Record notations, physician transcription etc. Description of treatment provided and patient outcome. A List of all SAEs/Deaths that have occurred during the course of the study in patients on-site or enrolled through this site. Changes required as a result of SAE/Death to the Protocol and or Consent (if applicable)

Final Report (Form F) (Attach a copy of each item listed below) YES NO N/A List of All Patients enrolled since last approval period and a copy of the signed signature page for each patient A List of all SAEs/Deaths that have occurred during the course of the study in patients on-site or enrolled through this site. A Brief summary of the results of the study to date