1. Update on the Enterprise Initiative: e-IRB and More Riyad Naser, MS, MBA Director of Research Information Systems Karen Blackwell, MS, CIP Director, Human Research Protection Program

2. CRIS Enterprise Initiative Initiative Goals Initiative Components Where We Are ▫GCRC Implementation ▫RI Implementation ▫E-IRB

3. Initiative Goals Standardize our processes Integrate research with clinical practice Integrated disciplines / departments Improve data quality Improve operational efficiency Facilitate inter-institutional collaboration

4. CRIS ENTERPRISE INITIATIVE Phase I (Implementation) Department Rollout E-Budget E-IRB Phase II (Integration) E-Budget Lab / Demographics Phase III E-Sample/IACUC Dependencies PeopleSoft / EHR CRIS Enterprise Initiative

5. CRIS ENTERPRISE INITIATIVE TIMELINE Phase I (Implementation) Phase II (Integration) Phase III 10/08-12/09 1/10-05/10 05/10-12/10 Initiative Timeline

6. Approaching the Enterprise Enterprise Level Department Level Vendor Level

7. Phase I (Implementation) Dept. RolloutE-BudgetE-IRB DISCOVERY PHASE: Current State CRIS System Standardization of forms and variable libraries Hardware upgrade System upgrade to 8.0 CRIS Resources Evaluate current resources Hire needed skills Identify environment dependencies Existing Environment Examine current installation at the Cancer Center Build on experiences Where to Start?

8. Current Hardware Environment

9. Standardizing Plan GCRC protocol and patient management CReDO regulatory office E-IRB Process

10. CReDO regulatory office Have a very detailed tracking system Capture research data in CRIS early on Manage their expectations

11. CReDO regulatory office.. Migration DescriptionNumber Studies imported into CRIS from Research Institute (RI)424 Imported IRB statuses into CRIS from RI database460 Sponsor Protocol Numbers imported into CRIS484 Studies activations form imported368 Adverse events imported in the system3170 Amendment Information Imported1638 Initial IRB Submissions Imported513 Imported Protocol Recertification991 Total records imported8048

12. E-IRB What? Why? How?

13. Current Process of HSC Submissions Everything is received, reviewed and processed on paper Routing on paper Time consuming for investigators Questions or additional forms may be missed, slowing the review Submissions go into a “black box”

14. Paper Review by the HSC Over 4300 actions in 2008 Printing costs in FY2008 were $28,000. Paper files are transported between desks and tables Reviews are on paper; provisos are transcribed from paper Lots of copying and filing

15. Transforming IRB Review Automate the entire submission process Prompts for missing questions or additional forms Automated scientific review and department sign-off Ancillary review (COI, RSC) would be automatically routed PRMC and GCRC functions would be housed in the same system

16. Transforming IRB Review - 2 Significant time-saving throughout the review process Electronic routing for review Electronic capture of reviewer comments Results can be distributed more efficiently Entire history of the project in one location More effective review

17. Benefits on All Levels Advantages for Investigators Improvements for Compliance Advantages for the Institution

18. Current State IRB Approval Process Paperwork dilemma Reviewer Load and responsibility Who is the reviewer? Meeting time, going through paper trail Review is done, time to issue Approvals Application is printed from HSC Website Application is rushed to HSC Office

19. CRIS Future State: e-IRB

20. E-IRB –Submitting a new application

21. E-IRB –Completeness check

22. E-IRB –Pending Items

23. E-IRB –Ongoing Studies

24. E-IRB………Manage Submissions

25. E-IRB………Reviewer Area

26. E-IRB………Manage Meetings

27. E-IRB Next Steps… Testing Phase Migration Go Live ▫Phase Approach ▫“Cold Turkey” Approach

28. Future Implications Standardize data collection and Approval process: e.g. baseline demographics, toxicity, laboratory forms, etc.) used in clinical research will become standardized in one system. Once a form is created, this template can be applied to any study Centralized location to track protocols and subject data Consolidate all protocol and subject information into one database, eliminating the need for stand-alone databases.