Office of Clinical Research: TGH Study Application

Project Coordinator: (OCR USE)
Finance Specialist: (OCR USE)
Date Received by OCR: (OCR USE)
FC Agenda Date: (OCR USE)

Please complete the following information accurately and to the best of your ability. If you need clarification on the forms, feel free to contact . Submissions will not be scheduled for review until they are deemed complete by OCR staff.

STUDY INFORMATION:

Study Title:
Principal Investigator (PI)
PI Affiliation/Department
PI Address
City, State, Zip
PI Telephone
PI Email
PI Pager
Study Coordinator (SC)
SC Telephone
SC Email
SC Pager
SC Fax
Other Investigators
Study Description: Please provide a detailed explanation of what will happen to subjects in the study
Standard Treatment: Please describe what treatment subjects would receive if they were not participating in the study
PI Has Privileges to Perform Study (OCR USE) / YES NO
SC Has Completed TGH Credentialing
(OCR USE) / YES NO N/A

STUDY DETAILS:

Study Type / DRUG
DEVICE
BIOLOGIC
REGISTRY
OTHER ______
Drugs/Devices/Agents Being Investigated (List by name)
Funding Source: / Sponsored
Grant Agency/Government
Investigator
Other ______
N/A
Sponsor/Manufacturer
Are these products FDA approved for this indication? / YES NO N/A
Please provide the following IND/IDE/HDE information and check the corresponding box to indicate it is attached / Copy of FDA Letter (required)
Investigator’s Brochure/Product Labeling (required)
Sponsor Reimbursement Package (if available)
IND/IDE/HDE number
Who will purchase the investigational drug/device/agent? / Physician/Practice Group
Tampa GeneralHospital (advanced purchase)
Tampa GeneralHospital (consigned/leased from sponsor)
Sponsor will provide free of charge
Other:
N/A
What is the cost of the drug/device/agent?
Where will the drug/device/agent be stored? / Physician/Practice Group
Tampa GeneralHospital:
Sponsor will provide on a case-by-case basis
N/A
DoesPI, spouse or dependent children, or any of the study personnel have financial or other interests related to this project or may be perceived to be related to this project? / No
Yes- Complete the TGH Conflict of Interest form for each individual of the study personnel with possible conflict.
If this is a device study, is an LCD required?
(OCR USE) / YES NO N/A
Date LCD Letter Received (OCR USE)

HOSPITAL INFORMATION:

Number of Subjects Requested at TGH
Estimated Length of Time (TGH Research Procedures) from first patient enrollment to last patient procedure / </= 1 year
___ years (round up months)
Which of the following research activities will occur at TGH? / Recruitment (flyers, screening, etc.)
Enrollment (consent)
Treatment (surgical procedures, nursing care, monitoring, etc.)
Labs
Diagnostics
Drug Dispensing
Drug Administration
Follow-Up
Location(s) where research will occur (select all that apply):
Specialty Surgery Unit
Oncology Unit
Gynecology Unit
Trauma/Surgery
Primary Care
Neurosciences
Psychiatric
Burn Center
Orthopaedics
JointCenter
ShortStayCenter
GE Center
Main OR
Cardiac OR
Cardiac Cath Lab
Angio/Interventional Suites
Outpatient Surgery
Pre-op/Surgical Prep Unit
PACU
Bariatric Center
CORE
Outpatient Diagnostics
Outpatient Laboratory Services
Pathology
ER
ICU—Trauma/Surgical
ICU—Neurosciences
ICU—Medical / ICU - Vascular
CTICU
CCU
Cardiac Transition
Cardiac/Vascular/Telemetry
Adult Step-Down
Cardiac Care
Transplant
Pediatric Medical/Surgical
PICU
NICU
Labor & Delivery
Antepartum/Postpartum
Pediatric Dialysis
Rehabilitation
Adult Dialysis
Clinics
30th Street—Family Practice
30th Street—Pediatrics
30th Street—Genesis
30th Street—Specialty
Kennedy—Family Practice
Outpatient Rehabilitation
Other:
Is there adequate staffing to conduct the study? (OCR USE) / YES NO
Is bed-space available? (OCR USE) / YES NO N/A
Describe your inservicing/training plans for all affected areas:
Expected Inpatient Length of Stay (LOS), other than Standard of Care
Which study visits will take place at TGH? (visit 1, visit 2, etc.)
Are any of the following additional resources needed for the study: / Additional Nursing Time (beyond standard-of-care)
Additional Tech Time (ECG, PCT, Ortho, SPD, Respiratory, EEG, etc.)
Special Equipment (computers, monitors, software, etc.)
Modifications to Existing Space (if known)
Supplies (kits, disposables, other, etc.)
N/A
If yes, please attach a description of the resources or e-mail this information to
Does this study require the use of the TGH laboratory/pathology? / YES NO
If yes, please submit the sponsor’s lab manual (processing section only) or email this information to
If yes, please indicate which of the following TGH lab/specimen services will be performed: / Storage YES NO
Processing YES NO
If storage of specimens is required, please indicate how long specimens will maximally be stored?
If storage of specimens is required, please indicate how often specimens will be collected from storage?
Will the TGH Investigational Drug Services be required to perform any tasks associated with this study? / YES NO
Please indicate which of the following will be performed at TGH: / Preparation
Dispensing
Randomization
Blinding
Dosing/Dose Calculation
Inventory Management/Accountability
Other (decontamination, order development, etc.)
N/A (no drug services required)
Have the sponsor budget terms been reviewed? (OCR USE) / YES NO N/A
Has the sponsor contract been reviewed? (OCR USE) / YES NO N/A
Billing Scenario:
(OCR USE) / 100% Research—completely billable to sponsor/study
100% 3rd Party—not billable to sponsor/study
Split Billing—partially billable to sponsor/study

APPROVAL CHECKLIST

TGH Approval for your study will not be granted, and enrollment cannot begin, until all of the processes below are completed:

Feasibility Assessment: The study must be approved by the TGH Feasibility Committee.

Sponsor Contract (if applicable): The TGH Indemnification Agreement or other sponsor contract needs to be signed by all applicable parties.

Budget Approval (Impact studies only): The budget needs to be approved and signed by PI.

IRB Approval: The study must be approved by USF IRB, WIRB, or other TGH approved private IRB and the Office of Clinical Research must receive a copy of the approval letter.Studies going to USF IRB will receive TGH approval prior to IRB submission. Please submit a copy of the IRB approval letter to the Office of Clinical Research once the study is approved.

Memorandum of Understanding: The Memorandum of Understanding outlines TGH policies for research and must be signed by both the PI and Study Coordinator.

Please indicate the Research Services that will be performed in this study. Please list only research-related services/procedures (for sponsored studies, please list all items that are covered in sponsor budget). If the study involves only standard-of-care services/procedures, which will not be reimbursed by sponsor, please leave this portion below blank. Complete the following information accurately and to the best of your ability. If you need clarification on the forms, feel free to contact . Submissions will not be scheduled for review until they are deemed complete by OCR staff.

Procedures/Tests: Performed by TGH staff or PI/Research Staff?
(please indicate which) / Description of Procedure/Test / Quantity Per Patient

Principal Investigator’s Attestation of Accuracy:

I hereby affirm that the above listed charges are an accurate reflection of the research costs of this study. These charges do not include any costs that are billable to insurance, or any standard-of-care costs for which reimbursement is paid by sponsor (if applicable). I also understand that the Office of Clinical Research will not issue a TGH Approval letter for my study, and enrollment cannot begin, until the above processes, listed in the Approval Checklist, are completed.

______

SignatureDate

Office of Clinical Research Acknowledgement of Receipt:

______

SignatureDate

The Approval Checklist is complete, TGH Approval letter has been issued, and PI can now begin enrollment in the study.

______

Director, Office of Clinical ResearchDate

Please submit all appropriate items to OCR Project Coordinator, CEDAR E-153. All forms must be submitted before evaluation for TGH approval will begin. Deadlines for Committee review are posted on the TGH Website.

TGH Study Application
LCD letter (for device studies)
Sponsor Budget (if applicable)
Name and Contact Info for Sponsor Contract Negotiations (if applicable)
Study Protocol
Drug or Device Data Sheet
IRB Application (and Approval Letter, if received)
Informed Consent form or waiver, containing TGH HIPAA language
Waiver of Authorization for PHI (if applicable)
FDA Letters (IND, IDE, etc.)
Investigator Brochure/Device Information
Sponsor lab manual (for studies involving TGH lab)
Current/Updated CV of PI (if not already on file within last 12 months)

Version date: 8/13/081