1. eProst: Re-Designed Adrian Boloix Human Subjects Research Office August 23 rd, 2006

2. Presentation Outline Introduction Timeline for New System Re-Deployment Current Limitations Current Enhancements Workflow New User Request Form Training Contact Information Questions & Answers

3. Introduction Electronic protocol submission & tracking system Helps the HSRO support and manage all biomedical and social behavioral research Uses Smartforms - the intelligent webforms that capture the study information entered by the (PT). Access via standard internet browser –Windows: Internet Explorer –Apple users: Safari (not Netscape)

4. Timeline for New System Re-Deployment September 18 th, 2006 New Smart Forms will be utilized by all eProst users November 1st, 2006 New Workflows will be available for Ophthalmology Workflow will go live for other departments using a “phased-in” approach.

5. Key Highlights for Re- Deployment Preview of Smartforms will be available for reference only on August 28 th, 2006 “Print and Send” mode will be utilized for new protocols; requiring PIs to submit 2 copies for review Continuing Report/Amendment for existing protocols will require completion of new protocol Smartform Reportable Event for existing protocols – will require completion of new Smartform either parallel to informing WIRB or after submitting the report to WIRB

6. Current Limitations Investigators required to print and submit paper copies of submissions; time consuming & error-prone Information capture, as required by federal regulations, state laws, and institutional policies, at times, has been lacking and limited.

7. Current Limitations Inability to provide instant updates to Investigators for tracking purposes. Information entry is time consuming since current protocol form asks all questions regardless of the study type.

8. Current Enhancements Faster turnaround time since paper submission will no longer be required by HSRO when workflow is fully implemented Submission tracking ease Minimized confusion since system mimics protocol process & not vice- versa.

9. Current Enhancements Improved communication –corrections occur directly between Protocol Team (PT) & HSRO Incorporated audit trail showing approvals –Shows all necessary information has been captured for appropriate exempt, expedited and full board review Refines the logic used to differentiate between Social/Behavioral & Medical studies –Only displays relevant questions for each

10. Workflow PT able to “submit”; thus, launching the information into the review workflow Provides a more streamlined process –turnaround time is reduced by eliminating the requirement of a hardcopy –minimizes possibility to lose paperwork

11. Workflow Diagram

12. Pilot Testing Results Testing with Ophthalmology will provide feedback on items to be addressed before the workflow is phased-in to other departments. Pilot testing will last 30 to 60 days. Additional departments will come onboard after January 1 st, 2007. Training for departments will be required in order to use the new workflow. Projections: A 5 phase deployment for the Medical Campus and a 3 phase deployment at the Coral Gables Campus.

13. New User Request Form More information required as part of enhanced security initiative Will provide enhanced security in the system via appropriate designation of permissions and roles C number will now be required for UM employees A notification will be sent on/before September 18 th, 2006 asking users to update information

14. Training Training Guides (in progress) New information will be relayed via eProst and HSRO eNews. Sign In sheet has been provided to facilitate access to HSRO eNews & this presentation

15. Whom to Contact HSRO IT GROUP Mr. Adrian Boloixaboloix@med.miami.edu305-243-3196aboloix@med.miami.edu Software Specialist II Mr. Daniel Augustedauguste@med.miami.edu305-243-3195dauguste@med.miami.edu IRB Senior Staff Assistant eProst General Technical Assistance Via email: eprost@med.miami.edueprost@med.miami.edu HelpDesk: 305-243-3195 EDUCATIONAL INITIATIVES Ms. Marisabel Davalosmdavalos@med.miami.edu 305-243-9769mdavalos@med.miami.edu BUSINESS & OPERATIONS Ms. Zuny Fernandezzfernand@med.miami.edu 305-243-9779zfernand@med.miami.edu

16. Questions?

17. THANK YOU FOR ATTENDING!