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the uf study registry and uf studyconnect understanding and supporting human subject research at uf n.
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Study Registry

Study Registry

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Study Registry

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

  2. Study Registry The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 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

  3. Human Subject Studies at UF 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. The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889

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

  5. Attributes of Studies • IRB Number • Review Type • Active status (IRB database) y/n • Study Title (as approved by the IRB) • Study Description • Keywords (up to five) • Approval date • Adult study y/n • Children under the age of 21 y/n • Children under the age of 18 y/n • Males included y/n • Females included y/n • Healthy Volunteers y/n • Has enrollment ended? y/n • Enroll end date • Enroll location (City, ST) • Biospecimens y/n • Clinical research y/n • Patient-Oriented y/n • Epidemiology/Behavioral y/n • Outcomes/Health Services y/n • Clinical trial y/n • Translational research y/n • T1 y/n • T2 y/n • T3 y/n • T4 y/n • Funding Agency • PeopleSoft Project Number • PI UFID • PI first name • PI last name • 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 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

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

  8. UF StudyConnect The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 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

  9. Current Effort The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 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

  10. Studies in Epic The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889 • 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

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

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

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

  14. Thank you! Project Team Alicia Turner Alison McMurray TaJuana Chisholm Katie Eddleton SherieLaurens Bethany Tennant Chris DeForce Neil Duncan CamiloGomez 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