1. Research Support Services UCH Facility Review Backlog Jennifer Holcomb

2. 2 Background: Each facility use review & approval takes about 4 hours Submissions over FY 2013 year: Quarter# Submissions# ApprovalsMedianMean Q1119*not tracked Q21261171518 Q310014057 Q4112981319

3. 3 Submissions first Quarter FY 2014: Month# Submissions# ApprovalsMedianMean July3323722 August4935714.5 September53331934.25 Q1135911225 Take Aways: Average 35-40 submissions per month = 140-160 work hrs per month Volume up over last 2 months (196- 212 work hrs needed) Increased volume at same time of process changes at UCH and UCD

4. 4 Plans to address backlog: 1-Adding staff resources 2- Asking for identification of priority protocols (phase 1, competitive enrollment) so we can meet the most urgent needs first as we work the backlog. 3- Posting weekly status log for Pre-Approval and log for Pre- Activation (to help increase transparency and decrease e mail volumes)

5. 5 The Research Community can HELP by: 1- Completing applications per instructions posted on web (include manuals and NCT numbers when required) 2- Following instructions for use of LIMITED REVIEW 3-

6. 6 Current New Submission Statistics: (As of 10/8/2014 at 12:00 pm) 68 Protocols Submitted (8 not yet complete) Of the 60 completed Submissions: 9 completed PRIOR to Sept 2014 in “Dept Feedback required” 11 completed PRIOR to Sept 2014 in “Billing Plan Development” Anticipate Completing these 20 as priorities over the next 2 weeks.

7. 7 Timelines: 1- Currently: Anticipate Studies with Applications Completed to have the following review and approval timelines- 2 days “received” 13 days “in review” 10 days “Department Feedback” 10 days “Billing Plan development 2- December: Return to Target of 3 weeks – 2 days “received” 7 days “in review” 7 days “Department Feedback” 5 days “Billing Plan Development”