CUMC IRB Investigator Meeting Status of the IRB January 18, 2005

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CUMC IRB Investigator MeetingStatus of the
IRBJanuary 18, 2005
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Objectives

• This presentation will provide information on
• Challenges facing the IRB
• Statistics on IRB Performance in 2004
• Changes during the past year
• Solutions/Plans to Improve IRB Quality and
  Performance

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• Challenges Facing the IRB
• High volume of submissions
• Regulatory requirements
• Addressing past noncompliance issues
• Staffing issues
• RASCAL
• IRB members Broaden expertise

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2004 IRB volume measured by submissions
Month Total
January 284
February 336
March 415
April 522
May 483
June 562
July 577
August 630
September 588
October 618
November 640
December 639















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2004 Staffing levels of the IRB adjusted for leave
Staff
January 27.74
February 27.8
March 26.63
April 26.2
May 26.4
June 21.09
July 22.5
August 20.77
September 19.26
October 19.38
November 19.4
December 18.61















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2004 Total approvals by CU/CUMC IRBs















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2004 Total approvals by CU/CUMC IRBs















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Individual IRB Performance Turnaround
TimeExpedited Review
IRBK (coded) Prot. Review Sub date App'l date Total IRB PI Returns
A1455 Exp 31223 40104 12 5 7 0.03
A4136 Exp 30123 30128 5 5 0 1
A3010 Exp 40114 40201 18 14 4 2
A3107 Exp 40311 40402 21 6 15 1
A2379 Exp 31015 40406 174 6 168 1
A4537 Exp 40227 40406 39 5 34 1
A7131 Exp 40514 40707 53 14 39 1
A6154 Exp 40514 40707 53 33 20 1
A6819 Exp 40602 40710 38 18 20 3
A6860 Exp 40702 41013 94 43 51 3
A9618 Exp 40907 41005 28 7 21 1
A9676 Exp 41001 41012 11 9 2 1
Total 546 165 381
Average 45.5 13.75 31.75 1.335833





























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Individual IRB Performance Turnaround TimeFull
Board Review
IRBK (coded) Prot. Review Sub date App'l date Total IRB PI Returns
A1186 FB 31124 40107 43 30 13 2
A1902 FB 31031 40118 79 30 49 2
A3919 FB 31230 40130 31 29 2 1
A2649 FB 31205 40406 123 46 77 3
A0174 FB 31119 40406 139 30 109 2
A4506 FB 40226 40414 50 25 25 1
A5771 FB 40408 40712 95 63 32 3
A6615 FB 40421 40712 82 54 29 2
A7958 FB 40621 40707 16 16 0 0
A5304 FB 40311 41005 208 40 168 3
A6281 FB 40412 41005 176 84 92 4
A7666 FB 40716 41027 103 40 63 2
Total 1145 487 659
Average 95.41667 40.58333 54.91667 2.083333















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Individual IRB Performance Turnaround
TimeExpedited Review
IRBL (coded) Prot. Review Sub date App'l date Total IRB PI Returns
A3707 Exp 31224 40102 9 9 0 0
A3389 Exp 31204 40104 31 20 11 1
A3784 Exp 31219 40107 19 18 1 2
A2857 Exp 40302 40408 37 23 14 2
A6674 Exp 40419 40422 3 3 0 0
A5588 Exp 40405 40423 18 4 14 1
A5908 Exp 40603 40701 28 15 13 2
A7967 Exp 40615 40701 16 16 0 0
A6014 Exp 40622 40708 16 11 5 1
A9041 Exp 40806 41004 59 43 16 2
B0070 Exp 40930 41012 12 12 0 0
B0050 Exp 40929 41012 13 13 0 0
Total 261 187 74
Average 21.75 15.58333 6.166667 0.916667











































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Individual IRB Performance Turnaround TimeFull
Board Review
IRBL (coded) Prot. Review Sub date App'l date Total IRB PI Returns




























A1307 FB 30724 40105 165 91 74 1
A2643 FB 30130 31217 48 40 8 2
A2596 FB 31021 40102 73 45 28 5
A2368 FB 31021 40403 165 108 57 5
A3921 FB 40227 40405 38 25 13 2
A4591 FB 40210 40405 55 22 23 2
A2926 FB 40324 40703 101 66 35 1
A4792 FB 40414 40703 80 43 37 3
A5398 FB 40406 40703 88 76 12 1
A8030 FB 40629 41001 95 83 12 2
A6806 FB 40616 41011 117 85 32 3
A8826 FB 40729 41011 74 64 10 3
Total 1099 748 341
Average 91.58333 62.33333 28.41667 2.5















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Individual IRB Performance Turnaround
TimeExpedited Review
IRBM (coded) Prot. Review Sub date App'l date Total IRB PI Returns




























A1699 Exp 30819 40114 148 43 105 2
A1520 Exp 31021 40115 86 39 47 4
A0200 Exp 30407 40122 290 41 249 3
A2578 Exp 40214 40411 57 54 3 1
A4323 Exp 40202 40411 69 45 24 2
A3752 Exp 31217 40411 116 57 59 3
A6194 Exp 40625 40716 21 15 6 2
A3070 Exp 31212 40727 228 69 159 5
A5920 Exp 40506 40727 82 38 44 4
A8480 Exp 40715 41001 79 39 40 1
A8712 Exp 40720 41001 74 59 15 2
A7631 Exp 40611 41010 121 51 70 2
Total 1371 550 821
Average 114.25 45.83333 68.41667 2.583333















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Individual IRB Performance Turnaround TimeFull
Board Review
IRBM (coded) Prot. Review Sub date App'l date Total IRB PI Returns














A2696 FB 31031 40105 66 64 2 1
A2363 FB 31010 40112 94 63 31 4
A4143 FB 40122 40405 74 48 26 2
A1823 FB 31125 40406 132 44 88 2
A1562 FB 31117 40409 143 96 47 4
A1500 FB 30728 40705 342 112 230 3
A0360 FB 30611 40705 390 149 241 7
A1789 FB 40108 40705 178 65 113 3
A8837 FB 40816 41001 46 35 11 2
B0177 FB 40930 41006 6 6 0 1
A2466 FB 40824 41010 47 38 9 1
Total 1518 720 798
Average 138 65.45455 72.54545 2.727273















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Individual IRB Performance Turnaround
TimeExpedited Review
IRBN (coded) Prot. Review Sub date App'l date Total IRB PI Returns




























A3750 Exp 31223 40101 9 9 0 0
A3325 Exp 31207 40105 29 28 1 1
A1414 Exp 31001 40115 116 3 113 1
A5319 Exp 40324 40412 19 15 4 2
A6074 Exp 40325 40420 26 26 0 0
A5528 Exp 40315 40420 36 33 3 1
A7738 Exp 40615 40709 24 9 15 1
A8001 Exp 40614 40714 30 17 13 2
A7764 Exp 40615 40721 36 23 13 3
A9899 Exp 40920 41006 16 16 0 0
A8466 Exp 40921 41011 20 14 6 1
A9103 Exp 40923 41013 20 20 0 0
Total 381 213 168
Average 31.75 17.75 14 1















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Individual IRB Performance Turnaround TimeFull
Board Review
IRBN (coded) Prot. Review Sub date App'l date Total IRB PI Returns














A3142 FB 31123 40115 53 49 4 1
A1812 FB 31210 40128 49 30 19 4
A3077 FB 40108 40121 13 6 7 2
A4484 FB 40311 40401 20 20 0 0
A1985 FB 30922 40405 196 50 146 7
A3073 FB 40212 40427 69 55 14 2
A2886 FB 40512 40630 49 38 11 1
A6716 FB 40512 40711 60 57 3 2
A7673 FB 40602 40714 48 42 6 1
A8347 FB 40806 41005 60 40 20 1
A8885 FB 40819 41006 48 38 10 2
A9370 FB 40916 41011 25 20 5 1
Total 690 445 245
Average 57.5 37.08333 20.41667 2















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Individual IRB Performance Turnaround
TimeExpedited Review2004






























Days IRB From Days
Days Studies Subm. To
w/ w/ Approval
IRB PI Returns
IRB K Total 12 546 165 381 16
IRB L Total 12 261 187 74 11
IRB M Total 12 1371 550 821 29
IRB N Total 12 381 213 168 12
Total 48 2,559 1,115 1,444 68
Average 53 days 23 days 30 days 1.42


IRBs are coded to maintain confidentiality Total
of 48 studies















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Individual IRB Performance Turnaround TimeFull
Boards Review2004






























Days IRB From Days
Days Studies Subm. To
w/ w/ Approval
IRB PI Returns
IRB K Total 12 1,145 487 659 25
IRB L Total 12 1,099 748 341 30
IRB M Total 12 1,518 720 798 30
IRB N Total 12 690 445 245 24
Total 48 4,452 2,400 2,043 109
Average 93 days 50 days 43 days 2.27








IRBs are coded to maintain confidentiality Total
of 48 studies















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Factors affecting data on IRB delays

• Possible causes from the IRB
• Waiting for Cancer Cmte. approval
• Waiting for IBC approval
• Reviewer delay (Need for more members)
• Need to obtain consultant/consultants review
• Volume at next available IRB meeting resulting in
  study scheduled on following meetings agenda

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Factors affecting data on IRB delays

• 2) Possible causes from the Investigator
• Waiting for approval of changes or updated
  documentation from the sponsor
• Waiting for documentation/action from FDA or
  other external agency
• Waiting for resolution of contract or other
  funding matters

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Possible causes of delays

• Investigator causes of delays
• Resubmitting a protocol without addressing all
  requests/concerns
• Timeliness of renewal submissions
• Lack of clarity of Rascal functions
• Missing documentation for protocols reviewed
  under an authorization agreement
• Attaching documents that the IRB cannot approve
  not archiving documents that have been replaced
• Attaching files in a format that cannot be opened
  by the IRB

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Possible causes of delays (contd)

• Investigator causes of delays
• Attaching files in a format that cannot be opened
  by the IRB
• Including protocol version dates in protocol
  titles, but not updating them when the version
  changes
• Making personnel changes in one document but not
  another
• Requesting a waiver of consent or documentation
  of consent, but not providing the justification
• Selecting names of attached files that are not
  related to the file, thus requiring IRB
  staff/members to open each document to find a
  specific file

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Possible causes of delays (contd)

• 2) IRB causes of delays
• Lack of clarity of Rascal functions with staff
• Lack of clarity of Rascal functions with IRB
  members
• Inflexibility of an electronic IT system

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Solutions/Plans to Improve IRB Quality and
Performance

• Provide more educational training targeted to
  issues related to IRB delays
• - Start regular workshops on RASCAL training?
• Improve IRBs website so that it becomes a
  valuable resource
• Improve management of IRB office use of
  tracking systems, increase accountability and
  performance
• Improve IRB committees by adding to the already
  high level of expertise with representation of
  more disciplines

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Tips to avoid IRB delays and returns

• Review the Tips to Facilitate Efficient Review
  documents on the IRB website
• Complete all fields in RASCAL, entering NA if
  appropriate
• Read the information on the Help buttons in the
  RASCAL screens
• Use cover letters attached to the submission to
  communicate to the IRB
• Review the list of attachments before each
  submission and archive superceded or obsolete
  documents
• Verify the protocol status after you submit
  and event
• Submit renewals 60 days prior to the expiration
  date

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Policy or Procedural Changes in IRB

• April 1, 2004 Discontinued continuing review of
  exempt research
• April 13, 2004 Released new AE Reporting policy
• September 2004 Implementation of accountability
  measures in IRB
• December 16, 2004 RASCAL change Allowing
  renewals to be
  resubmitted for expired protocols

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IRB Goals for 2005

• Apply for Accreditation and receive full
  accreditation status
• Improve the efficiency of the IRB so that
  average turnaround time is less than 2 months
• Improve the quality of IRB review
• Improve the quality of Columbias human subjects
  protection program