julie pepe, biostatistician - florida hospital · pdf filerevised to align with new ora...

Revised to align with new ORA scholarly work and case study processes

Improved to capture appropriate PHI and medical record information

Available now for use via IRBNet Library

Required effective December 1, 2014

IRB Reviews Prep to Research Form – Revised

3

Initial or

continuing review

& log updates

Don’t forget!

4

Replaces Jurisdictional Waiver form

Submit with initial request to rely upon Quorum

Allows teams to designate access to Quorum’s OnQPortal

Available in IRBNet Library

Quorum Cover Page

5

Quorum or

sponsor #

Check B

Portal

access

6

Quorum Uses OnQ Portal

Requires:

Quorum cover page

Rationale for use of boilerplate consent language Refer Quorum to FH SOPs

SIQ

WIRB Uses Connexus

Requires:

FH IRB letter of agreement

Boilerplate consent language

Investigator Submission Form

External IRB Review

FH IRB has access to both systems and is copied on

correspondence from both IRBs.

7

Invites went out yesterday (11/12) and request investigators to respond by 12/30/14

Monday, January 19, 2015 at 6:00-7:00 p.m. – FH Orlando Campus, Werner

Tuesday, January 20, 2015 at 7:00-8:00 a.m. – FH Orlando Campus, Werner

Tuesday, January 20, 2015 at 6:00-7:00 p.m. – FH Celebration, Mangroves

Research directors will receive report after 12/30 with names of those who have not responded. Your help to coordinate responses is appreciated.

Research directors are welcome to attend. Please let the IRB office know if you are interested.

Investigator Forum 2015

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Upcoming ORA Classes

Informed Consent 11/18 at 10:am (CEU available)

Data Collection 12/9 at 3pm (CEU available)

Statistical Basics for Researchers 12/10 at 3:30pm (1hr)

Budget Development 12/10 at 2:00 pm (1 hr)

ORA Announcements

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An award for innovation has been set up in Des Cummings honor to recognize FH employees who have shown pioneering work in the area of innovation.

This year’s award went to the team lead by Roger Smith at the Nicholson Center/Celebration Health:

Roger Smith

Alyssa Tanaka

Courtney Graddy

ORA Announcements (continued)

Des Cummings Innovation 2014 Award

10

ORA Announcements (continued)

Move to Maitland – Date TBA

901 N. Lake Destiny Drive

11

IRB meeting Thanksgiving week

Training & Credentials Expiration reminders are sent well in advance

IRB recommendations for your teams – Ensure Emails are correct in IRBNet

Track your team - create a system that works for you

IRB Reminders

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• IRB’s Michelle McKinney passed her Certified IRB Professional Exam (CIP)

IRB Recognition

13

3rd Quarter Enterprise Report

Florida Hospital Research Enterprise3rd Quarter 2014

09/30/2014

Research Enterprise 2014Cancer Institute

Jane Crofton

2501 N Orange Ave. Suite 683

Orlando, FL 32804

ThrombosisJohn Francis

2501 N Orange Ave.

Suite 786

Orlando, FL 32804

TransplantAnne Epley

2415 N Orange Ave Suite 700

Orlando, FL 32804

Translational

Research InstituteChris Davis

301 E Princeton St.

Orlando, FL 32804

PharmacyRichard Montgomery

601 E Rollins St. Box 128

Orlando, FL 32803

Nursing ResearchSandra Galura

701 E Altamonte Dr. Suite 4100

Altamonte Springs, FL 32701

NeuroscienceCherlynn Basignani


Orlando, FL 32804

GMEVictor Herrera


Orlando, FL 32804

Global

Robotics InstituteMaria Delaroza

410 Celebration Place

Celebration, FL 34747

Celebration

HealthMadeline O’Connor

400 Celebration Place Box 33

Celebration, FL 34747

CardiovascularTheresa Sessions


Orlando, FL 32803

IRB

Institutional

Review

Board212 E Winter Park St.

Orlando, FL 32804

ORA

Office of

Research

Administration228 E Winter Park St.

Orlando, FL 32804

Cancer R&DSally Litherland

2501 N Orange

Ave Suite 247

Orlando, FL 32804

OrthoJason Croft

2501 N Orange Ave Suite 235

Orlando, FL 32804

Florida

Urology Associates Felipe Valerio

1812 N Mills Ave.

Orlando, FL 32803

Children’sPatricia Robinson


Orlando, FL 32803

Interventional

EndoscopyAmy Logue

2501 N. Orange Ave, Suite 240

Orlando, FL 32804

SurgeryPaula Veldhuis

2415 N. Orange Ave, Suite 401

Orlando, FL 32804

Winter Park

Memorial HospitalNadine McDaniel

200 N. Lakemont Ave.

Winter Park, FL 32789

RadiologyCarole Coyne

601 E. Rollins St., ox 163

Orlando, FL 32803

Snapshot of Studies by Sponsor211

176

31

150

186

164

31

159

186

168

32

149

CancerConsortium

Industry Non-Industry Florida Hospital

Q1

Q2

Q3

n=535as of 09/30/14

Industry Sponsored

Studies by Type

Drug65

Device53

Other35

CUDs6

HUDs9

0

10

20

30

40

50

60

70

80

n=168as of 09/30/14

Florida Hospital Sponsored

Studies by TypeProspective

84

Retrospective41

Registry13

Case Study2

Non-Human Subjects

9

n=149as of 09/30/14

Studies by Research DeptCancerClinicalTrials226

Cardiovascular62

Children's34

TRI32

Celebration25 Cancer

R&D22

GME19

Endoscopy19

NSI16

Transplant12

Thrombosis9

Surgery8

FL Urology8

Radiology6

GRI5

Ortho5

Nursing3Pharmacy

2

WPMH1

Independent15

n=535as of 09/30/14

Cancer Institute

Clinical Trials Division

• 232 studies

– 186 Cancer Consortium

– 44 Industry Sponsored

– 2 Non-Industry

• 32 FTEs

• Largest research institute with 2 separate

departmentsResearch &

Development Division

• 22 studies

• 20 FH Sponsored

• 2 Non-Industry

Sponsored

Collaboration

• 8 FTEs

Cardiovascular

• 62 studies– 38 Industry Device

– 10 Industry Drug

– 7 Industry Other

– 1 HUD

– 4 Non-Industry Sponsored

– 2 FH Sponsored

• 11 FTEs

• 34 studies– 9 Industry Sponsored

• 2 Drug

• 3 Other

• 1 HUD

• 3 CUD


– 13 Florida Hospital

Sponsored

• 6 Prospective

• 5 Retrospective

• 2 Registry

• 6 FTEs

Children’s Hospital


• 4 Drug

• 2 Other

– 3 Non Industry Sponsored

– 23 Florida Hospital Sponsored

• 21 Prospective

• 2 Non-Human Subjects

• 89 FTEs

TRI - Translational

Research Institute


• 3 Device

• 5 Other

• 1 HUD



Sponsored

• 11 Prospective

• 2 Retrospective

• 1 Registry

• 1 Non-Human Subjects

• 6.5 FTEs

Celebration Health


• 2 Device

• 1 Other



Sponsored

• 12 Prospective

• 2 Registry

• 2 FTEs

Center for

Interventional

Endoscopy• 19 studies



• 2 Prospective

• 12 Retrospective

• 2 Registry

• 1 Case Studies

• 1.3 FTEs

• 60 faculty and 150

residents supported

Graduate

Medical

Education

Neuroscience


• 1 Drug

• 2 Device

• 4 HUD



Sponsored

• 5 Prospective

• 2 Retrospective

• 1 Registry

• 5 FTEs

Transplant • 12 studies in the area of

kidney, liver, lung, and

heart transplantation– 11 Industry Sponsored

• 5 Drug

• 1 Device

• 4 Other

• 1 CUD


• 1 Retrospective

• 3 FTEs

Center for

Thrombosis

Research• 9 studies

– 5 Industry Sponsored -

Other



Sponsored

– 1 Prospective study

– 1 Non-human subjects

study

• 10 FTEs

Center for

Specialized

Surgery

• 8 FH Sponsored

studies– 4 Prospective

– 4 Retrospective

• 1 FTE

Florida

Urology

Associates• 8 studies

– 3 Industry Drug

– 3 Industry Device

– 2 Industry Other

• 1 FTE

Radiology

• 6 Studies – 1 Industry Device


sponsored studies

• 1 Prospective

• 3 Retrospective

• 1 Case Studies

• 1 FTE

Global

Robotics

Institute

• 5 studies– 2 Industry Other

– 3 FH Sponsored

– 1 Prospective

– 1 Retrospective

– 1 Registry

• 5 FTEs• 2 coordinators

• 3 data abstractors

Pharmacy

• 2 Studies – Florida Hospital sponsored studies

• 1 Prospective

• 1 Retrospective

• 3.2 FTEs

• Research is primarily from

pharmacy residents

• Investigational Pharmacy

provides services in

support of research studies

Nursing Orthopaedics

• 5 studies– 3 Industry Drug

– 2 FH Sponsored

Prospective

• 2 FTEs

• 3 studies - Florida

Hospital Sponsored– 1 Prospective

– 1 Retrospective

– 1 Non-human subjects

• 7.5 FTEs in the

department, supporting

research and multiple

programs across 8 campuses.

Approximately 3.5 FTEs

dedicated to research.Winter Park

Memorial Hospital• 1 FH Sponsored

study (prospective)

• 1 FTE

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Steven SmithChief Scientific Officer

Rob HerzogVice President

30

Thank you for your attendance at

Research Matters!

julie pepe, biostatistician - florida hospital · pdf filerevised to align with new ora...

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