Research Support Services Update to RAF for December Jennifer Holcomb

2 Submissions FY 2015 to Date: Month# Submissions July34 August50 September45 October75 November68 December*22 as of 12/10 Take Away: Volume continues to be exceed last years volume. First Quarter: 129 submissions ~520 work hrs review & approval (=1 FTE) Second Quarter to date*: 165 submissions ~ 660 work hrs review & approval

3 Additional outstanding concerns and backlog issues for RSS: Valid NCT Numbers in EPIC Data Request turnaround time Updates to Grant Tickets/Billing Plans Other Amendment Requests Epic modifications and updates Education and Training requests

4 Facility Use Approval Management Update: 1-Add staff: Decision made to support staffing increase in Oct. Positions approved and posted, offers made November. December two new staff begin (1 billing team/ 1 review team). Continued need for resources- 1 vacancy; request for another reviewer- currently filled with a 3 month contract. 2- Post weekly status logs for UCH began in late October, Pending Facility Use Approval and Pending Activation logs being posted weekly. LAPS logs shared with CCTO weekly.

5 Current Pending Facility Use Approval Statistics: 12/10/14 at 9pm 65 Protocols in Submission Status: 26 Incomplete/Not thru Portal: Sept(2); Oct (5); Nov (7); Dec (9)* 6 Study Team Feedback Needed: Oct (2); Nov (4) 33 in progress with RSS: Sept (1); Oct (2); Nov (23); Dec (7) *CRSC will begin reviewing reports to assist study teams with portal issues 11/12/14 at 9pm 74 Protocols in Submission Status: 19 Incomplete/Not thru portal: Sept (4); Oct (8); Nov (7) 17 Study Team Feedback Needed: Sept (6); Oct (7); Nov (4) 38 in progress with RSS: Sept (4); Oct (18); Nov (16) 10/8/14 at 12:00 pm 68 Protocols in Submission Status (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”

6 Pending Activation Report Also posted weekly on portal webpage Outlines outstanding items that must be provided to RSS before an approve study may be activated for enrolling patients Possible items: UCD sign-off; Contract; NCT#; IRB Approval; Beacon Build (Cancer Center) RED=on UCD Daily report Currently 110 studies on this Report CRSC will begin providing assistance to study teams regarding necessary completion of outstanding items required for enrollment to open

7 The Research Community can HELP by: 1- Completing applications per instructions posted on web (include manuals and NCT numbers when required- provide as soon as received) 2- Following instructions for use of LIMITED REVIEW- Continued confusion about when limited review may be used. (see instructions on portal page/handout) 3- Refer to posted status logs; Allow target review times to elapse prior to making inquiries

Update on Device Workgroup

9 Purpose: RAF Chairs asked Dr. Patel and Jennifer Holcomb to co-chair a workgroup to discuss process for opening Device studies and make recommendations for ways to streamline process. Members: Dr. Vikas Patel, Jennifer Holcomb, Dr. Joseph Cleveland, Tracy McDermott, Dr. John Messenger, Amy Fung, Dr. Gary Luckasen, Alison Lakin, Christine Ahearn, Ashly Walsh, Amy Gannon Meetings: Difficult to schedule. Series of 6 additional meetings set for every 2 weeks beginning in January. 2 meetings to date- First, introductions and identified additions to make current membership list. Second began detailed discussion of all necessary steps and components Identified issues to date: Education regarding requirements Communication regarding documents