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Human Subjects Office Monthly Update

December 28, 2011

As reported previously, the Human Subjects Office (HSO) identified on October 20 615 items that were "in screener backlog," - waiting for HSO staff to review. Our commitment was to doing everything possible to ensure that 50% of these items would be reviewed by December 1st, and to have 80% reviewed by December 31st. As of December 7, 2011, all 615 items had been reviewed, and 89% have been approved. Of the 69 submissions awaiting approval at that time, 24 were awaiting IRB or staff action, and 45 awaiting PI action.

In early December, HSO conducted a thorough inventory of all items in its queues, and identified 197 items received before October 20 which were not at that time ready for screener review. These items were not identified in as "screener backlog". As of December 23rd, 121 of those items had been approved; 11 were waiting staff or IRB action, and 65 were awaiting PI action prior to additional review.

Below are tables that provide additional metrics regarding the progress of the HSO.

Item October volume completed October mean Turn Around Time November volume completed November mean Turn Around
Time
% change, volume % change, TAT
Amendments 229 64 349 52 52% -18%
Co-Investigator Updates * * 265 32 * *
Continuing Reviews 168 40 273 38 63% -5%
Exempt Protocols 48 68 153 53 219% -22%
Expedited Protocols 51 62 98 58 92% -6%
Full Board Protocols 12 79 25 98 108% 37%
TOTAL, ALL ITEMS 508 62 1163 55 129% -11%

* Co-Investigator updates were not included in October tracking data.

HSO Throughput
  October # received October # completed October Throughput November # received November # completed November Throughput % change
Continuing Reviews & Closeout Requests 267 223 -44 177 273 96 318%
Amendments & Co-investigator Updates 343 349 6 361 614 253 4117%
Exempt Protocols 76 48 -28 93 153 60 314%
Expedited Protocols 41 51 10 62 98 36 260%
Full Board Protocols 24 12 -12 20 25 5 142%