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).

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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

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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

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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

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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

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