1. The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 The UF Study Registry and UF StudyConnect: Understanding and Supporting Human Subject Research at UF

2. Study Registry Create a Comprehensive database of all approved human subject research at UF since 2008 N=8589 (through 2011) All four IRBs All Colleges All review types – full board, expedited, exempt All studies The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

3. Human Subject Studies at UF The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 IRBsHealth CtrCampusJacksonvilleWesternTotal 2011 (est)69512171821442238 201068311701711412165 200968712051611242177 200864710591531502009 Total271246516675598589 Working with each IRB, the UF CTSI team hand codes each study for 33 attributes including T1-T4 research, keywords, lay description, PI and department information.

4. 26% of data collected so far The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 IRBsHealth CtrCampusJacksonvilleWesternTotal 2011287945026457 20106451576965936 2009933191010513 20081320960228 Total1157570316912134 Data collection has focused on establishing collection processes with each of the IRBs, quality of coding. Emphasis on recent Health Center studies

5. Attributes of Studies 1.IRB Number 2.Review Type 3.Active status (IRB database) y/n 4.Study Title (as approved by the IRB) 5.Study Description 6.Keywords (up to five) 7.Approval date 8.Adult study y/n 9.Children under the age of 21 y/n 10.Children under the age of 18 y/n 11.Males included y/n 12.Females included y/n 13.Healthy Volunteers y/n 14.Has enrollment ended? y/n 15.Enroll end date 16.Enroll location (City, ST) 17.Biospecimens y/n 18.Clinical research y/n 19.Patient-Oriented y/n 20.Epidemiology/Behavioral y/n 21.Outcomes/Health Services y/n 22.Clinical trial y/n 23.Translational research y/n 24.T1 y/n 25.T2 y/n 26.T3 y/n 27.T4 y/n 28.Funding Agency 29.PeopleSoft Project Number 30.PI UFID 31.PI first name 32.PI last name 33.PI department The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

6. Breakdown by College so far Agriculture117 Business37 Dentistry73 Design, Constr &P20 Education81 Engineering35 Fine Arts23 HHP36 Journalism54 Law3 Liberal Arts179 Medicine1367 Nursing47 Pharmacy118 Public Health207 Vet Med2 Admin18 Shands18 Unknown86 Office of Research4 VA18 The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

7. Some notes regarding studies Studies are not grants Some studies are clinical trials Studies are approved IRB protocols for all types of human subject research The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

8. UF StudyConnect A public facing web site designed for the general public Help people find studies of potential interest Connect people to the researchers performing the studies The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

9. Current Effort Work with 179 open, coded studies Work with the investigators of those studies Review data, text, functionality of the StudyConnect web site If you don’t want to be listed, contact us If you do want to be listed, contact us If you have a proposed change, contact us The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

10. Studies in Epic An effort to clarify research billing and improve operations – All studies that bill – All studies using a drug – All studies using a device – All sensitive studies Approximately 250 studies The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

11. Studies in ClinicalTrials.gov All studies meeting Clinical Trials.gov requirements must register with ClinicalTrials.gov Will be determined by IRB upon approval Approximately 300 studies The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

12. Next steps Continue coding Summarize data for 2011 Stay caught up with new studies Convert to Click Commerce when available The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

13. Future work Code according to OCRE Integrate with other systems Develop additional recruitment strategies The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

14. Thank you! Project Team Alicia Turner Alison McMurray TaJuana Chisholm Katie Eddleton Sherie Laurens Bethany Tennant Chris DeForce Neil Duncan Camilo Gomez Project Sponsors Mike Conlon David Nelson Wajeeh Bajwa Betsy Shenkman Subject Matter Experts Claire Baralt Bob Kolb Michael Mahoney Cheryl Dykeman Ira Fischler Denise Long Tina Bottini Alan Berger Sheila Austin Belinda Carlton Colleen Ebel Carlos Morales Sean Jeng The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889