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UFIR



The UF Study Registry and UF StudyConnect: Understanding and Supporting Human Subject Research at UF
www.ufl.edu ( Publisher's URL )
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Permanent Link: http://ufdc.ufl.edu/IR00000709/00001
 Material Information
Title: The UF Study Registry and UF StudyConnect: Understanding and Supporting Human Subject Research at UF
Physical Description: Powerpoint presentation
Creator: Conlon, Michael
Publisher: University of Florida
Place of Publication: Gainesville, FL
Publication Date: December 8, 2011
 Notes
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Michael Conlon.
Publication Status: Published
 Record Information
Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the submitter.
System ID: IR00000709:00001

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PAGE 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

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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

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Human Subject Studies at UF The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 IRBs Health Ctr Campus Jacksonville Western Total 2011 ( est ) 695 1217 182 144 2238 2010 683 1170 171 141 2165 2009 687 1205 161 124 2177 2008 647 1059 153 150 2009 Total 2712 4651 667 559 8589 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.

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26% of data collected so far The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 IRBs Health Ctr Campus Jacksonville Western Total 2011 287 94 50 26 457 2010 645 157 69 65 936 2009 93 319 101 0 513 2008 132 0 96 0 228 Total 1157 570 316 91 2134 Data collection has focused on establishing collection processes with each of the IRBs, quality of coding. Emphasis on recent Health Center studies

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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

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Breakdown by College so far Agriculture 117 Business 37 Dentistry 73 Design, Constr &P 20 Education 81 Engineering 35 Fine Arts 23 HHP 36 Journalism 54 Law 3 Liberal Arts 179 Medicine 1367 Nursing 47 Pharmacy 118 Public Health 207 Vet Med 2 Admin 18 Shands 18 Unknown 86 Office of Research 4 VA 18 The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

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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

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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

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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 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

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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

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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

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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

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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

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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