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IRB Reviews Prep to Research Form Revised 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
Initial or continuing review & log updates Don t forget! 3
Quorum Cover Page Replaces Jurisdictional Waiver form Submit with initial request to rely upon Quorum Allows teams to designate access to Quorum s OnQ Portal Available in IRBNet Library 4
Quorum or sponsor # Check B Portal access 5
External IRB Review WIRB Uses Connexus Requires: FH IRB letter of agreement Boilerplate consent language Investigator Submission Form Quorum Uses OnQ Portal Requires: Quorum cover page Rationale for use of boilerplate consent language SIQ Refer Quorum to FH SOPs FH IRB has access to both systems and is copied on correspondence from both IRBs. 6
Investigator Forum 2015 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. 7
ORA Announcements 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) 8
ORA Announcements (continued) Des Cummings Innovation 2014 Award 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 9
ORA Announcements (continued) Move to Maitland Date TBA 901 N. Lake Destiny Drive 10
IRB Reminders 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 11
IRB Recognition IRB s Michelle McKinney passed her Certified IRB Professional Exam (CIP) 12
3 rd Quarter Enterprise Report 13
Florida Hospital Research Enterprise 3 rd Quarter 2014 09/30/2014
Research Enterprise 2014 Cancer Institute Jane Crofton 2501 N Orange Ave. Suite 683 Orlando, FL 32804 Winter Park Memorial Hospital Nadine McDaniel 200 N. Lakemont Ave. Winter Park, FL 32789 Florida Urology Associates Felipe Valerio 1812 N Mills Ave. Orlando, FL 32803 Thrombosis John Francis 2501 N Orange Ave. Suite 786 Orlando, FL 32804 Transplant Anne Epley 2415 N Orange Ave Suite 700 Orlando, FL 32804 Translational Research Institute Chris Davis 301 E Princeton St. Orlando, FL 32804 Surgery Paula Veldhuis 2415 N. Orange Ave, Suite 401 Orlando, FL 32804 ORA Office of Research Administration 228 E Winter Park St. Orlando, FL 32804 Radiology Carole Coyne 601 E. Rollins St., ox 163 Orlando, FL 32803 Cancer R&D Sally Litherland 2501 N Orange Ave Suite 247 Orlando, FL 32804 Pharmacy Richard Montgomery 601 E Rollins St. Box 128 Orlando, FL 32803 Cardiovascular Theresa Sessions 601 E Rollins St. Box 99 Orlando, FL 32803 IRB Institutional Review Board 212 E Winter Park St. Orlando, FL 32804 Ortho Jason Croft 2501 N Orange Ave Suite 235 Orlando, FL 32804 Celebration Health Madeline O Connor 400 Celebration Place Box 33 Celebration, FL 34747 Nursing Research Sandra Galura 701 E Altamonte Dr. Suite 4100 Altamonte Springs, FL 32701 Children s Patricia Robinson 601 E Rollins St. Box 207 Orlando, FL 32803 Global Robotics Institute Maria Delaroza 410 Celebration Place Celebration, FL 34747 GME Victor Herrera 2501 N Orange Ave. Suite 235 Orlando, FL 32804 Interventional Endoscopy Amy Logue 2501 N. Orange Ave, Suite 240 Orlando, FL 32804 Neuroscience Cherlynn Basignani 2501 N Orange Ave. Suite 111 Orlando, FL 32804
Snapshot of Studies by Sponsor 211 n=535 as of 09/30/14 186 186 176 164 168 150 159 149 Q1 Q2 Q3 31 31 32 Cancer Consortium Industry Non-Industry Florida Hospital
80 Industry Sponsored Studies by Type n=168 as of 09/30/14 70 60 50 Drug 65 Device 53 40 Other 35 30 20 10 0 CUDs 6 HUDs 9
Florida Hospital Sponsored Studies by Type Prospective 84 n=149 as of 09/30/14 Retrospective 41 Registry 13 Case Study 2 Non-Human Subjects 9
Studies by Research Dept Cancer Clinical Trials 226 n=535 as of 09/30/14 Cardiovascular 62 Children's 34 Celebration TRI 25 Cancer Endoscopy 32 R&D 19 22 GME 19 Transplant NSI 12 16 Thrombosis 9 FL Urology Surgery 8 8 Radiology 6 GRI 5 Ortho 5 Nursing 3 Pharmacy 2 Independent 15 WPMH 1
Clinical Trials Division 232 studies Cancer Institute Largest research institute with 2 separate departments Research & 186 Cancer Consortium 44 Industry Sponsored 2 Non-Industry 32 FTEs 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 Children s Hospital 34 studies 9 Industry Sponsored 2 Drug 3 Other 1 HUD 3 CUD 12 Non-Industry Sponsored 13 Florida Hospital Sponsored 6 FTEs 6 Prospective 5 Retrospective 2 Registry
Celebration Health TRI - Translational Research Institute 32 studies 6 Industry Sponsored 4 Drug 2 Other 3 Non Industry Sponsored 23 Florida Hospital Sponsored 21 Prospective 2 Non-Human Subjects 89 FTEs 25 studies 9 Industry Sponsored 3 Device 5 Other 1 HUD 1 Non-Industry Sponsored 15 Florida Hospital Sponsored 11 Prospective 2 Retrospective 1 Registry 6.5 FTEs 1 Non-Human Subjects
Graduate Medical Education 19 studies 2 Non-Industry Sponsored 17 Florida Hospital Sponsored 2 Prospective 12 Retrospective 2 Registry 1.3 FTEs 1 Case Studies 60 faculty and 150 residents supported Center for Interventional Endoscopy 19 studies 3 Industry Sponsored 2 Device 1 Other 2 Non-Industry Sponsored 14 Florida Hospital Sponsored 2 FTEs 12 Prospective 2 Registry
Neuroscience 16 studies 7 Industry Sponsored 1 Drug 2 Device 4 HUD 1 Non-Industry Sponsored 8 Florida Hospital Sponsored 5 FTEs 5 Prospective 2 Retrospective 1 Registry 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 Florida Hospital Sponsored 3 FTEs 1 Retrospective
Center for Thrombosis Research 9 studies 5 Industry Sponsored - Other 2 Non-Industry Sponsored 2 Florida Hospital Sponsored 10 FTEs 1 Prospective study 1 Non-human subjects study Center for Specialized Surgery 8 FH Sponsored studies 4 Prospective 4 Retrospective 1 FTE
Radiology Florida Urology Associates 8 studies 3 Industry Drug 3 Industry Device 2 Industry Other 1 FTE 6 Studies 1 Industry Device 5 Florida Hospital sponsored studies 1 FTE 1 Prospective 3 Retrospective 1 Case Studies
Pharmacy 2 Studies Florida Hospital sponsored studies 1 Prospective 3.2 FTEs 1 Retrospective Research is primarily from pharmacy residents Investigational Pharmacy provides services in support of research studies Global Robotics Institute 5 studies 2 Industry Other 3 FH Sponsored 1 Prospective 1 Retrospective 1 Registry 5 FTEs 2 coordinators 3 data abstractors
Nursing 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. Orthopaedics 5 studies 3 Industry Drug 2 FH Sponsored Prospective 2 FTEs Winter Park Memorial Hospital 1 FH Sponsored study (prospective) 1 FTE
Steven Smith Chief Scientific Officer Rob Herzog Vice President 29
Thank you for your attendance at Research Matters! 30