eProst: Re-Designed

Adrian BoloixHuman Subjects Research Office

August 23rd, 2006

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

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)

Timeline for New System Re-Deployment

September 18th, 2006New Smart Forms will

be utilized by all eProst users

November 1st, 2006New Workflows will

be available for Ophthalmology

Workflow will go live for other departmentsusing a “phased-in”

approach.

Key Highlights for Re-Deployment

• Preview of Smartforms will be available for reference only on August 28th, 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

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.

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.

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.

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

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

Originating Department Review Ancillary Committee Review (if needed)

HSRO RegulatoryReview

Approved

Protocol Review(Exempt, Expedited, & Full Board)

External Consultation(if needed)

Pre-Submission

Disapproved

Workflow Diagram

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 1st, 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.

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 18th, 2006 asking users to update information

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

Whom to ContactHSRO IT GROUP

Mr. Adrian Boloix aboloix@med.miami.edu 305-243-3196Software Specialist II

Mr. Daniel Auguste dauguste@med.miami.edu305-243-3195IRB Senior Staff Assistant

eProst General Technical AssistanceVia email: eprost@med.miami.eduHelpDesk: 305-243-3195

EDUCATIONAL INITIATIVES

Ms. Marisabel Davalos mdavalos@med.miami.edu 305-243-9769

BUSINESS & OPERATIONS

Ms. Zuny Fernandez zfernand@med.miami.edu 305-243-9779

Questions?

THANK YOU FOR ATTENDING!