IRB Reviews Prep to Research Form Revised

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2 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

3 Initial or continuing review & log updates Don t forget! 3

4 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

5 Quorum or sponsor # Check B Portal access 5

6 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

7 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

8 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

9 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

10 ORA Announcements (continued) Move to Maitland Date TBA 901 N. Lake Destiny Drive 10

11 IRB Reminders IRB meeting Thanksgiving week Training & Credentials Expiration reminders are sent well in advance IRB recommendations for your teams Ensure s are correct in IRBNet Track your team - create a system that works for you 11

12 IRB Recognition IRB s Michelle McKinney passed her Certified IRB Professional Exam (CIP) 12

13 3 rd Quarter Enterprise Report 13

14 Florida Hospital Research Enterprise 3 rd Quarter /30/2014

15 Research Enterprise 2014 Cancer Institute Jane Crofton 2501 N Orange Ave. Suite 683 Orlando, FL Winter Park Memorial Hospital Nadine McDaniel 200 N. Lakemont Ave. Winter Park, FL Florida Urology Associates Felipe Valerio 1812 N Mills Ave. Orlando, FL Thrombosis John Francis 2501 N Orange Ave. Suite 786 Orlando, FL Transplant Anne Epley 2415 N Orange Ave Suite 700 Orlando, FL Translational Research Institute Chris Davis 301 E Princeton St. Orlando, FL Surgery Paula Veldhuis 2415 N. Orange Ave, Suite 401 Orlando, FL ORA Office of Research Administration 228 E Winter Park St. Orlando, FL Radiology Carole Coyne 601 E. Rollins St., ox 163 Orlando, FL Cancer R&D Sally Litherland 2501 N Orange Ave Suite 247 Orlando, FL Pharmacy Richard Montgomery 601 E Rollins St. Box 128 Orlando, FL Cardiovascular Theresa Sessions 601 E Rollins St. Box 99 Orlando, FL IRB Institutional Review Board 212 E Winter Park St. Orlando, FL Ortho Jason Croft 2501 N Orange Ave Suite 235 Orlando, FL Celebration Health Madeline O Connor 400 Celebration Place Box 33 Celebration, FL Nursing Research Sandra Galura 701 E Altamonte Dr. Suite 4100 Altamonte Springs, FL Children s Patricia Robinson 601 E Rollins St. Box 207 Orlando, FL Global Robotics Institute Maria Delaroza 410 Celebration Place Celebration, FL GME Victor Herrera 2501 N Orange Ave. Suite 235 Orlando, FL Interventional Endoscopy Amy Logue 2501 N. Orange Ave, Suite 240 Orlando, FL Neuroscience Cherlynn Basignani 2501 N Orange Ave. Suite 111 Orlando, FL 32804

16 Snapshot of Studies by Sponsor 211 n=535 as of 09/30/ Q1 Q2 Q Cancer Consortium Industry Non-Industry Florida Hospital

17 80 Industry Sponsored Studies by Type n=168 as of 09/30/ Drug 65 Device Other CUDs 6 HUDs 9

18 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

19 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 GME 19 Transplant NSI Thrombosis 9 FL Urology Surgery 8 8 Radiology 6 GRI 5 Ortho 5 Nursing 3 Pharmacy 2 Independent 15 WPMH 1

20 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

21 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

22 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

23 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

24 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

25 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

26 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

27 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

28 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

29 Steven Smith Chief Scientific Officer Rob Herzog Vice President 29

30 Thank you for your attendance at Research Matters! 30