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Annual Report FY 2005 - 2006

IRB Data

NEW Protocols Initiated from FY 2001 - 2006

 

FY - 01

FY - 02

FY - 03

FY - 04

FY - 05

FY - 06

Clinical Trials

25

29

34

26

22

29

Investigator-Initiated

16

18

21

33

29

26

Expedited Category

19

24

14

22

29

29

Exempt Category

46

53

66

82

52

68

TOTALS

106

124

135

163

132

152

CONTINUING Reviews and AMENDMENTS / MODIFICATIONS from FY01- 06

 

FY - 01

FY - 02

FY - 03

FY - 04

FY - 05

FY - 06

Continuing Reviews / Final Reports

121

140

158

170

168

171

Amendments(Full Board)

6

7

17

8

22

21

Other Amendments / Modifications

195

243

293

339

388

346

Protocol submission and review is only one indicator of increased OPHS and IRB activity.

A more descriptive measure is "Board Actions" which is a composite metric including
all of the following:

IRB Board Actions

 

FY 2005

FY 2006

 

Clinical Trials (New protocol reviews)

22

29

 

Investigator-Initiated (New protocol reviews)

29

26

 

Expedited (new protocol reviews)

29

29

 

Exempt Category (new protocol reviews)

52

68

 

Deferred (Full Board Review more than once)

4

11

 

Protocol Violations / Deviations

4

28

 

CONTINUING REVIEWS / Final Reports

168

171

 

Amendments (Full Board Review)

22

23

 

Amendments/Modifications (non-Full Board review)

388

346

 
Total Protocol Actions

714

730

 

Serious Adverse Event (SAE) Reports

 

 

 

On-Site (at UNTHSC)

100

87

 

Off-Site (other non-UNTHSC locations)

742

* 1,282

 
Total SAEs

842

1,433

 

Total of all Board Actions (Protocol and SAEs)

1,556

2,163

 

 

 
 
UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER at Fort Worth
Center for BioHealth
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 This page was last updated: 11/18/2008

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