January 18, 2012. Different workflow for USF eIRB compared to WIRB submission Should receive an initial response from us (by email or eIRB) within.

The TGH OCR Review Process From A to Z

January 18, 2012

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

Review WorkflowWorkflow

USF eIRB Workflow:

Western IRB Workflow:

TGH Study Application

Full Study Title: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged >/= 13 Years

Short Title: Tamiflu for H1N1 or seasonal flu

Short Study Description: Effectiveness and safety of iv oseltamivir (Tamiflu, antiviral neuraminidase inhibitor) in patients with suspected or confirmed H1N1 or seasonal influenza; must be < 97 hrs between the onset of influenza-like illness and the first dose of oseltamivir.

Review WorkflowFor Example:

TGH Study Application

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.

Review WorkflowStudy Treatment: Please provide an explanation of what will happen to subjects in the study and specifically describe what will occur at each study visit       

Poor Example:

An international double cohort study to compare Laparoscopic Ventral Rectopexy with Laparoscopic Resection Rectopexy

Review WorkflowStudy Treatment: Please provide an explanation of what will happen to subjects in the study and specifically describe what will occur at each study visit       

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.

Poor Example:

No standard treatment is defined, the treatment varies with certain physicians.

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.

Review WorkflowStandard Treatment: Please describe what treatment patients would receive if they were not participating in the study (i.e. What is the standard of care?)       

TGH Study Application

TGH Study Application

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

Conflict of Interest Process

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.

CoI Examples

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

Conflict of Interest Process

TGH Study Application

TGH Study Application

TGH Study Application

Review WorkflowFor Example:

Performed by TGH staff or PI/Research Staff?

(please indicate which)

Description of Procedure/Test:

Quantity per Patient

TGH staff 6-minute walk test 2 (at 1 and 3 months post-VAD)

TGH lab Fibrinogen 16

TGH lab D-Dimer 16

PI or Research staff NIH Stroke scale 1 as needed

TGH Study Application

TGH Study Application

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.”

TGH Requirements for ICF

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.”

TGH Requirements for ICF

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

Local Coverage Determination

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 current one on file, within last 2 years)

IRB application (not required at time of Feasibility submission)

Other Items Needed

TGH Data Request Form

TGH Data Request Form

TGH Data Request Form

TGH Data Request Form

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)

Research Credentialing Process –Students and Volunteers

When you have a new coordinator or student in your dept. please submit the following information to OCR for their Epic access:

1. Full name2. Date of birth3. City of birth4. Last 6 digits of SSN5. 6-digit TGH badge #6. 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 #.

EPIC Access Requests

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

Who to call?

Jennifer Cooper, Director, 844-4236, [email protected]

Beth Kohl, Supervisor, 844-7482, [email protected]

Hayley Kourtellis, Project Coordinator, 844-8113, [email protected]

Kevin Klahr, Research Financial Analyst, 844-8189, [email protected]

Sandy Puentes, Research Finance Specialist, 844-3869, [email protected]

Laura Julien, Administrative Assistant, 844-7989, [email protected]

TGH OCR Admin. Staff