Data Collection Process for a Comprehensive Human Subject Study Registry and Research Participant Web Site
www.ufl.edu ( Publisher's URL )
Full Citation
Permanent Link: http://ufdc.ufl.edu/IR00000797/00001
 Material Information
Title: Data Collection Process for a Comprehensive Human Subject Study Registry and Research Participant Web Site
Physical Description: Conference Poster
Creator: Alicia Turner
Alison McMurray
Michael Conlon
The Study Registry Team
Publisher: University of Florida
Place of Publication: Washington DC
Publication Date: August 19, 2012
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: IR00000797:00001


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Method How are data being collected? Data collection is done manually from paper IRB records. Every member of the CTSI Study Registry team is thoroughly trained on primary data collection techniques, which includes extensive review of the data dictionary, code book and working with IRB files. All team members are required to spend a full day shadowing an experienced coder. This process includes reading through previously coded protocols to understand how NIH data elements are coded with a mentor there to field questions. Team members begin data collection on their own once mentoring is complete. Quality Assurance sessions are scheduled bi weekly to ensure accuracy and consistency with the data collection process As a final step to ensure accuracy, the PI of each study is given the opportunity to review the information that will be publicly available on the UF StudyConnect website Figure 2. Data collection process. All studies are stored in the registry. Actively enrolling studies are also presented on UF StudyConnect What data are being collected? 37 data elements are being collected across the four UF IRBs for all human subject research studies approved at UF since 2008 (full board, expedited and exempt). Figure 3. Data Collection Form D ata elements colored green are used to identify actively enrolling studies for possible inclusion on UF StudyConnect Selection criteria: Review Type = full board or expedited, Active = yes, Has enrollment ended = no. D ata elements colored blue are either searchable or displayed on the UF StudyConnect website, which is available to the public. All other data elements are housed in a database maintained by the CTSI. Results Table 2. Data collection progress as of March 30, 2012. Figure 3.Translational Research at the University of Florida overall and by IRB 2011 Figure 4. UF Study Connect web site http://studyconnect.ctsi.ufl.edu UF StudyConnect launched January 19, 2012 with 276 studies; 117 studies added since launch for 219 PIs 2008 2009 2010 2011 2012 Total IRB01 159/642 251/1702 672/705 704/708 49/153 1835/2910 IRB02 0/1111 321/1297 576/1253 400/1338 0/301 1297/5300 IRB03 142/154 143/162 160/174 168/181 25/30 651/688 IRB04 93/154 88/132 147/147 64/83 2/9 394/524 Total 394/2061 803/2293 1555/2278 1349/2297 76/493 4177/9422 Data Collection Process f or a Comprehensive Human Subject Study Registry and Research Participant Web Site Overview The UF Health System, and research teams across UF, the CTSI is developing a study registry to: studies Assist with recruitment of subject participants Improve portfolio of human subject research. The CTSI Study Registry project will create a comprehensive data set with consistently defined data elements for all human subject research studies approved at UF since 2008, plus actively enrolling studies approved before 2008. The data collected will be used in two ways: 1. Selected data elements for actively enrolling studies are publicly available on a website called UF StudyConnect ( http://studyconnect.ctsi.ufl.edu ), which individuals can use to search for opportunities to participate in research. This component launched in January 2012. 2. The full data set will enable the CTSI and other stakeholders to analyze aspects research and translational stages of research (T1 T4 ). Background: The Need The University of Florida does not currently have comprehensive data regarding its Review Boards : 1. IRB 01: Gainesville Health Science Center 2. IRB 02: Behavioral Non Medical 3. IRB 03: Jacksonville Health Science Center 4. IRB 04: Western IRB (industry sponsored, FDA regulated clinical studies) Each IRB keeps its own records in its own formats. The CTSI Study Registry project will create a single, comprehensive, electronic resource listing all UF human subject research studies across all IRBs Table 1. Counts of studies to be included in the study registry. The counts for 2012 increase regularly as new studies are approved. Environment Human Subject Studies include studies that make use of the electronic medical record, studies that can make use of web based recruitment and studies that must be registered in clinicaltrials.gov. The study registry includes all human subject studies regardless of these other requirements. Figure 1. Relation of study registry studies to subsets in other systems A. Turner A. McMurray, M. Conlon, and the Study Registry Team*, University of Florida, Gainesville, FL The Study Registry team : Kaitlin Brennan, Miguel Chateloin TaJuana Chisholm, Christopher DeForce Neil Duncan, Katherine Eddleton Camilo Gomez, Swaroop Kondreddy Sherie Laurens, Rebecca Richie, Bethany Tennant W ork supported in part by the NIH/NCRR Clinical and Translational Science Awards to the University of Florida UL1 RR029890, KL 2 R R029888 and TL1 RR029889. 2008 2009 2010 2011 2012 Total IRB01 642 702 705 708 153 2,910 IRB02 1,111 1,297 1,253 1,338 301 5,300 IRB03 154 162 174 168 30 688 IRB04 154 132 146 83 9 524 Total 2,061 2,293 2,278 2,297 493 9,422 Project Impact This project creates a fundamental new capability for UF. We will have a unified registry connects interested individuals with information about research studies that are open for enrollment. The registry also will facilitate analysis of the types of human subject research conducted across UF. Future Work 1. Develop web data entry form using Visual Studio 2. UF StudyConnect transitions to UF&Shands health care enterprise 3. Integrate with myIRB (Click Commerce) 4. Sync required data with clinicaltrials.gov 5. Sync required data with the electronic medical record (epic)