The TGH OCR Review Process From A to Z

Report
January 18, 2012
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Different workflow for USF eIRB compared to
WIRB submission
Should receive an initial response from us (by
email or eIRB) within 1 week of study submission
PI-initiated protocols are reviewed by our Medical
Writer, Dr. Sadaf Aslam
Goal of 3-week approval time for Exempt and
Expedited studies (if no major issues)
Most drug and device studies require Feasibility
Committee review
◦ Includes representatives from various departments
(nursing, lab, pharmacy, OR) plus physicians and TGH
OCR staff
USF eIRB
Workflow:
Western IRB
Workflow:
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Full Study Title:
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Short Title:
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Short Study Description: Effectiveness and safety of
A Multicenter Study of the Safety of
Oseltamivir Administered Intravenously for the Treatment of
Influenza in Patients Aged >/= 13 Years
Tamiflu for H1N1 or seasonal flu
iv oseltamivir (Tamiflu, antiviral neuraminidase inhibitor) in
patients with suspected or confirmed H1N1 or seasonal
influenza; must be < 97 hrs between the onset of influenzalike illness and the first dose of oseltamivir.
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Good Example:
Patients that meet the inclusion/exclusion criteria for the study will be approached in a
private exam room at the Florida Heart Rhythm Institute. All patients in the study will
receive ablation therapy for their arrhythmia regardless of participation in the trial. If
the patient fully understands the parameters of the study and is willing to sign the ICF,
the subject will be blindly randomized to receive either the investigational ablation
catheter (Safire BLU Duo Irrigated Ablation System) or a control FDA approved ablation
catheter (NaviStar Thermocool) to be used during their ablation procedure.
Randomization will be achieved with an IVRS system. The purpose of the study is to test
the safety and efficacy of the Safire BLU Duo Irrigated Ablation System for the treatment
of symptomatic paroxysmal atrial fibrillation. The data generated from this study will be
used to fulfill a premarket approval application for the FDA. Subjects will be followed in
the study after their ablation procedure at 30 days, 3, 6, and 12 months. All follow up
visits will occur at the Florida Heart Rhythm Institute and will involve quality of life
questionnaires and holter monitoring.
The investigational Safire BLU Duo Irrigated Ablation catheter is a 7F radiofrequency
ablation catheter with conduits that allow for heparinized saline irrigation during the
procedure. The catheter system will be paired with a 3D mapping system, irrigation
pump, and tubing set; all of which are used on a regular basis for ablation procedures at
TGH.
The control NaviStar ThermoCool is a 7F irrigated radiofrequency ablation catheter. This
catheter will be paired with the CARTO 3D mapping system both of which are currently
used in the cath lab.
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Poor Example:
An international double cohort study to compare Laparoscopic
Ventral Rectopexy with Laparoscopic Resection Rectopexy
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Good Example:
At TGH, donor sites are covered with Mepilex dressings for 7 days unless
wound dressing becomes saturated and requires changing at an earlier time.
At post-operative day 7, if the wound is fully epithelialized, the Mepilex
dressing is removed and betaglucan ointment is applied to the wound and
the wound is left open to air. If the wound is not fully epithelialized but
appears to be healing and free of infection, a new Mepilex dressing is applied
to the wound and the wound is checked 2 days later. If the wound is not
healing properly, a thin layer of silvadene is applied with a bulky gauze
dressing changed daily.
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Poor Example:
No standard treatment is defined, the treatment varies with certain
physicians.
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Revised:
No standard treatment is defined, the treatment varies with certain
physicians. The standard of care for the majority of patients is the use of
Entereg.
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USF and other affiliates are responsible for
handling their own employees’ CoI issues
TGH study application requires PI and all
study team members to disclose any CoI
related to the study for themselves, their
spouses, or their children
If yes, they fill out the TGH CoI form to
disclose the details of the conflict
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Anything of monetary value, or a potential value, including, but not
limited to, salary or other payments for services (e.g., consulting
fees or honoraria) that are paid or given to the Investigator (or the
Investigator’s immediate family), directly or indirectly, as support for
the activities of the investigator, in addition to the fees for
conducting the clinical study.
A proprietary interest in the Study, including an issued patent,
trademark, copyright, or licensing agreement of the study
drug/device or method.
A position as director, officer, partner, trustee, or member of board
of directors of any entity related to the research study.
A consulting, advisory, employment, ownership/equity, or any other
interest or relationship in any entity related to the research study
(including interests in a non-publicly traded corporation).
Any other financial interest or external commitment that the
Investigator believes may interfere with his or her ability to protect
human research participants.
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OCR Supervisor and Director will determine
whether a CoI management plan is required
If yes, the Supervisor and Director will review the
PI’s management plan and consult with TGH
Corporate Compliance, if needed
When CoI plan is approved by TGH, PI will submit
the plan to the IRB for review and approval
For USF studies, TGH will inform USF Division of
Research Integrity and Compliance if TGH
determines that a CoI management plan is not
required
Performed by TGH staff or
PI/Research Staff?
(please indicate which)
Description of
Procedure/Test:
Quantity per Patient
TGH staff
6-minute walk test
TGH lab
Fibrinogen
2 (at 1 and 3 months postVAD)
16
TGH lab
D-Dimer
16
PI or Research staff
NIH Stroke scale
1 as needed
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Required TGH-approved HIPAA language:
◦ For USF consents:
“Research at Tampa General Hospital is conducted jointly with the
University of South Florida. By signing this form, you are permitting
Tampa General Hospital and the University of South Florida to use
personal health information collected about you for research purposes.
You are also allowing Tampa General Hospital to share your personal
health information with individuals or organizations other than USF and
Tampa General Hospital who are also involved in the research and listed
below.”
◦ For WIRB consents:
“By signing this form, you are permitting Tampa General Hospital to
receive, use, and share personal health information collected about you
for research purposes within Tampa General Hospital health care
system. You are also allowing Tampa General Hospital to share your
personal health information with other individuals or organizations who
are also involved in this research.”
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Required TGH-approved Injury Statement:
◦ Preferred language:
“In the event you suffer an injury or illness as a result of participating in this
research study, please be aware that immediate, short-term medical treatment for
the injuries or illness will be available to you from Tampa General Hospital. You
will not be responsible for the costs related to these injuries. No compensation will
be offered. You are not giving up any legal rights by signing this form. If you
believe you have experienced a reaction to the study drug/device or have been
injured as a result of research procedures performed at Tampa General Hospital,
please contact the Department of Risk Management at (813) 844-7666.”
◦ Alternate language:
“In the event you suffer an injury or illness as a result of participating in this
research study, please be aware that immediate, short-term medical treatment for
the injuries or illness will be available to you from Tampa General Hospital. The
cost of the medical treatment will be billed to you to the extent not covered by
your insurance company or government program or study sponsor. No other
compensation will be offered. You are not giving up any legal rights by signing
this form. If you believe you have experienced a reaction to the study drug/device
or have been injured as a result of research procedures performed at Tampa
General Hospital, please contact the Department of Risk Management at (813)
844-7666.”
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A Local Coverage Determination (LCD) for
CMS approval is required for all device
studies where any portion of the research
study is billed to insurance, even if the
sponsor is providing the device free of charge
If the sponsor is covering all research charges
(i.e. nothing billed to insurance), then you do
not need to apply for an LCD with First Coast
Service Options
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Study protocol (or upload through eIRB)
ICF template (or upload through eIRB)
Drug or Device data sheet (for inpatient studies)
Research Information sheet (for drug studies only)
FDA approval letter (for IND, IDE, 510k)
IB (drug studies) or IFU (device studies)
PI’s signed and dated CV (if we don’t already have a
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IRB application
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current one on file, within last 2 years)
submission)
(not required at time of Feasibility
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OCR Credentialing Application
Resume/CV
Human subjects education (CITI program or
USF Foundations course)
PI statement of responsibility (for students)
TGH badge will be issued
All other research coordinators need to be
credentialed through Human Resources
(Gisela Yecora, 844-4969)
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When you have a new coordinator or student in your
dept. please submit the following information to OCR
for their Epic access:
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Full name
Date of birth
City of birth
Last 6 digits of SSN
6-digit TGH badge #
Dept. name and phone #
Coordinators will also need to complete online training
in Mindlab (http://tgh.learn.org), under ‘My Learning’
Your username is your 6-digit badge # with the first
number replaced with a letter (0=a, 1=b, 2=c, etc.). If
you have never logged in before, your default password
is the first initial of your first name (capitalized), the
first initial of your last name (lower case), and the last 4
digits of your badge #.
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For the TGH review process, study forms,
Feasibility outcome, or status of your study:
contact Beth Kohl or Hayley Kourtellis
For contracts, indemnification, or credentialing:
contact Beth Kohl
Questions about budgets or billing: please contact
Kevin Klahr
For enrollment forms or scanning of consents:
contact Sandy Puentes
If you have a question regarding the USF eIRB
system or IRB submissions call the IRB help desk at
974-2880
If you have a question about using Epic, please call
the TGH IT help desk at 844-7490
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Jennifer Cooper, Director, 844-4236, [email protected]
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Beth Kohl, Supervisor, 844-7482, [email protected]
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Hayley Kourtellis, Project Coordinator, 844-8113,
[email protected]
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Kevin Klahr, Research Financial Analyst, 844-8189,
[email protected]
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Sandy Puentes, Research Finance Specialist,
844-3869, [email protected]
Laura Julien, Administrative Assistant, 844-7989,
[email protected]

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