Please complete the following information accurately and ...
Office of Clinical Research:
TGH Study Application
Anything that says
Project Coordinator: (OCR USE)
OCR Use will be
Finance Specialist: (OCR USE)
filled in by our staff.
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 research@. Submissions will not be scheduled for review until they are deemed complete by OCR staff.
STUDY INFORMATION: Full Study Title:
This is the full protocol title.
Short Title: (descriptive title to be used for study identification in EPIC/EMR, 30 character limit) Short Study Description: (short description for EPIC/EMR, 1-2 sentences summarizing the purpose of the study, 255 character limit) Principal Investigator (PI) PI Affiliation and Department PI Address City, State, Zip PI Telephone PI Email PI Pager/Cell Phone Study Coordinator (SC) SC Telephone SC Email SC Pager/Cell Phone Other Investigators
This is a short name that we will file the study under in Epic. We prefer something that describes the study, i.e. doxorubicin for pancreatic cancer (drug name and indication). This is a brief description that we will import to Epic once the BPAs go live. This will let any other provider know a little about the study in case they wish to refer their patient to the PI.
We need all the PI and SC contact information.
Please list all other sub-investigators.
Study Treatment: Please provide an explanation of what will happen to subjects in the study and specifically describe what will occur at each study visit
This should list a brief description of each study visit, specifying which research procedures will occur at TGH. i.e. How does the research differ from standard of care treatment?
Standard Treatment: Please describe what treatment patients would receive if they were not participating in the study (i.e. What is the standard of care?)
This should briefly describe how the patients would be treated if they were NOT in the research study. i.e. What is the investigator's standard of care for this patient population?
Please make sure you are using the most
Version date: 8/25/11
current version (check our website).
1
Office of Clinical Research:
TGH Study Application
STUDY DETAILS:
Study Type:
DRUG
DEVICE
This is only for biological agents
BIOLOGIC
administered (i.e. monoclonal
DATA COLLECTION/aRnEtiGbIoSdTieRsY). Specimen collection
PROCEDURE
should be marked as "other".
OBSERVATIONAL
OTHER _____________________________
Drugs/Devices/Agents/Procedures Being
Investigated (List by name):
IRB Name:
USF IRB
WIRB
OTHER _____________________________
If using WIRB, is WIRB generating the
YES
NO
N/A
Informed Consent document?
Funding Source:
Sponsored
Grant Agency/Government (e.g. NIH, DOD)
Investigator
Other _____________________________
N/A
Sponsor/Manufacturer:
If sponsored, please provide contact information for contracts:
Are these products FDA approved for this indication?
If your drug or device has an NEPhmaoYmaniEeel__S___________________N_____O___________________N______/A_________lawIeN___pet___Dtpe___wr__r_oo.i___lrvl___eIn__D_de___Ee__f_o,drthathecinsoipitnyidsoicnfaotthtioenFaDnAd
Please provide the following
Copy of FDA Letter (required)
IND/IDE/HDE information and check the
Investigator's Brochure/Product Labeling (required)
corresponding box to indicate it is attached. IND/IDE/HDE number:
Sponsor Reimbursement Package (if available) Please fill in the IND or IDE number (should be on your protocol or IB).
Who will purchase the investigational
Physician/Practice Group
drug/device/agent?
Tampa General Hospital (advanced purchase)
Tampa General Hospital (consigned/leased from sponsor)
Sponsor will provide free of charge
Other:
N/A
Please indicate the price of the drug/
$
Sponsor usually provides free of charge, but if not,
device/agent for purchase or consignment
you will need to list the estimated cost to TGH.
Where will the drug/device/agent be
Physician/Practice Group
stored?
Tampa General Hospital Investigational Pharmacy
Sponsor will provide on a case-by-case basis
Other: N/A
Drugs should always be stored in the TGH Investigational Pharmacy.
Version date: 8/25/11
2
Office of Clinical Research:
TGH Study Application
CONFLICT OF INTEREST: Does PI, 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.
HOSPITAL INFORMATION: Number of Subjects Requested at TGH Which of the following research activities will occur at TGH?
We need this number in order to build our TGH budget for the correct # of patients.
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 Joint Center Short Stay Center 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
After the study is approved, we send a notification letter to the selected departments, informing them of the upcoming study.
Clinics 30th Street--Family Practice 30th Street--Pediatrics 30th Street--Genesis 30th Street--Specialty
Kennedy--Family Practice
Outpatient Rehabilitation
HMT-300 Lung Transplant Clinic
409 Bayshore TGMG Clinic
Other:
Version date: 8/25/11
3
Office of Clinical Research:
TGH Study Application
Even if everything is done by the research team, you still
Describe your inservicing/training or notification plans for all affected areas:
have an obligation to inform the nurse managers of the affected units, just to make them aware of the study.
Does this study require the use of either
TGH lab CORE lab NO lab required
the TGH laboratory/pathology or CORE
lab? CORE lab is in
If either lab is required, please submit sponsor's lab manual
HMT-450 clinic.
(processing section only) or email it to research@
If CORE lab is utilized, please indicate
Storage
Processing
which of the following lab/specimen
services will be performed:
Shipping
Dry Ice
If specimens will be processed in CORE lab, will you require use of CORE staff to process? Will the TGH Investigational Drug Services be required to perform any tasks associated with this study?
If yes, please indicate which of the following TGH Investigational Drug Services will be performed:
YES
NO
YES
NO
If yes, please submit an additional copy of the Investigator
Brochure and protocol to the Research Pharmacy or email this
information to researchpharmacy@
Preparation Dispensing Randomization Blinding Dosing/Dose Calculation
All drug studies should involve the use of the Investigational
Inventory Management/Accountability Pharmacy, even if
Order Development
only for inventory
Other:
management and
N/A (no drug services required)
accountability.
Version date: 8/25/11
4
Office of Clinical Research:
TGH Study Application
BUDGET WORKSHEET:
Will subjects be admitted to the hospital
NO
These 2 questions refer
solely as a result of this research study?
YES, # of days:
to hospital admission for
N/A, this is an outpatient study only research only or length
Is it possible a subject's length of stay may be prolonged as a result of participating in this research study?
NO YES, # of days: N/A, this is an outpatient study only
of stay extended beyond standard of care.
Which study visits will involve
Please make sure you list the visits that will
procedures at TGH? (visit 1, visit 2, etc.) happen at TGH.
Will TGH CORE be utilized for any
YES
NO
N/A
study visits?
CORE is HMT-450 clinic.
If yes, how many visits will require use # of visits:
hrs per visit:
total hrs needed:
of a patient room in CORE?
Are any of the following additional TGH
Additional Nursing Time (beyond standard-of-care)
resources needed for the study:
Additional Tech Time (ECG, PCT, Ortho, SPD, Respiratory,
We are only looking for things that might be above and beyond their standard job duties.
EEG, etc.) Supplies (kits, disposables, other, etc.) Other: N/A
If yes, please attach a description of the resources or e-mail this information to research@
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 research@. Submissions will not be scheduled for review until they are deemed complete by OCR staff.
Performed by TGH staff or PI/Research Staff?
(please indicate which)
TGH or Research staff
Description of Procedure/Test:
Please only list research procedures/labs that are not part of the PI's standard of care.
Quantity Per Patient
Version date: 8/25/11
5
Office of Clinical Research:
TGH Study Application
PROFESSIONAL FEE INFORMATION:
Laboratory: Please be advised that you may be charged laboratory reading fees by Ruffolo, Hooper and Associates. TGH has no control over the assessment of these fees. Please contact Ruffolo, Hooper and Associates at 890-0138 to obtain and/or negotiate these fees at research rates.
Radiology: Please be advised that you may be charged radiology reading fees by Radiology Associates. TGH has no control over the assessment of these fees. Please contact Radiology Associates at 253-2721 to obtain and/or negotiate these fees at research rates.
EKG: Please be advised that you may be charged EKG reading fees by EKG Interpretation. TGH has no control over the assessment of these fees. Please contact Debbie at 254-2441 to obtain and/or negotiate these fees at research rates.
If your study does not involve any additional professional services, then these fees are not applicable.
If this is a non-sponsored study, please be aware that your study may be sent to the USF CTSI Scientific Review Committee for further review. Please let the TGH Office of Clinical Research know if you would prefer to opt out of this additional review.
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 below processes, listed in the Approval Checklist, are completed.
We need the PI's original signature, attesting to the research
_p_r_o_c__e_d_u__re__s__o_n__t_h_e__p_r_e_v__io_u__s__p_a_g__e_.________________________________________________________________________
Signature
Date
Office of Clinical Research Acknowledgement of Receipt:
____________________________________________________________________________________________________________
Signature
Date
Please submit all appropriate items to OCR Project Coordinator, Harbourside Medical Tower, Suite 470. 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 applicable device studies)
? Sponsor Budget (required for all sponsored studies)
? Name and Contact Info for Sponsor Contract Negotiations (required for all sponsored studies)
? Study Protocol
? Drug or Device Data Sheet (required for inpatient studies)
? Research Information Sheet (required for inpatient drug studies only)
? IRB Application (and Approval Letter, if received)
? Informed Consent form, containing TGH HIPAA language and TGH Subject Injury language
? FDA Letters (IND, IDE, etc.)
? Investigator Brochure or Device Information
? Sponsor lab manual (required for studies involving TGH or CORE lab)
? Current/Updated CV, signed by PI (if not already on file within last 12 months)
Version date: 8/25/11
6
Office of Clinical Research:
TGH Study Application
OCR CHECKLIST:
OCR staff will complete this page.
PI Has Privileges to Perform Study:
YES
NO
N/A, no patient contact
SC Has Completed TGH Credentialing:
YES
NO
N/A
If this is a device study, is an LCD
NO
required?
YES, date received:
N/A
Is there adequate staffing to conduct the
YES
NO
study?
Is bed-space available?
YES
NO
N/A
Is an Order Set required for this study?
YES
NO
N/A
Has the sponsor budget been reviewed?
YES
NO
N/A
Has the indemnification/contract been
YES
NO
N/A
initiated with sponsor?
Billing Scenario:
100% Research--completely billable to sponsor/study
100% 3rd Party--not billable to sponsor/study
Split Billing--partially billable to sponsor/study
Administrative Only--admin fee billable to sponsor/study
N/A--there is no billing component for this study
Scientific Review:
Primary reviewer:
Secondary:
Dept. Notification Letters:
Date sent:
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.
Scientific Review: The study must be reviewed by an independent physician or nurse, at the
request of the OCR.
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 or WIRB 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 review. 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.
The Approval Checklist is complete, TGH approval letter has been issued, and PI can begin enrollment once the study is approved by the IRB.
____________________________________________________________________________________________________________
Director, Office of Clinical Research
Date
Version date: 8/25/11
7
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