Transcript Slide 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
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
Human Subject Studies at UF
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.
The UF CTSI is supported in part by NIH awards
UL1 RR029890, KL2 RR029888 and TL1 RR029889
26% of data collected so far
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
The UF CTSI is supported in part by NIH awards
UL1 RR029890, KL2 RR029888 and TL1 RR029889
Attributes of Studies
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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
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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
Breakdown by College so far
Agriculture
Business
Dentistry
Design, Constr &P
Education
Engineering
Fine Arts
HHP
Journalism
Law
Liberal Arts
117
37
73
20
81
35
23
36
54
3
179
Medicine
Nursing
Pharmacy
Public Health
Vet Med
Admin
Shands
Unknown
Office of Research
VA
1367
47
118
207
2
18
18
86
4
18
The UF CTSI is supported in part by NIH awards
UL1 RR029890, KL2 RR029888 and TL1 RR029889
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
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
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
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
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
Next steps
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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
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
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