IT Briefing March 2006. 2 IT Briefing Agenda 3/16/06 Security Announcements eResearch Overview Housing Overview & Demo Update on current performance problems.

IT Briefing

March 2006

2

IT Briefing Agenda 3/16/06

• Security Announcements

• eResearch Overview

• Housing Overview & Demo

• Update on current performance problems

• NetCom Q&A

• Jay Flanagan

• John Wilson

• Heather Mugg

• AAIT & NetCom

• Paul Petersen

Novell TechTalkTuesday March 21 9:30am – 11:00amNDB-230 Enterprise

Security Announcements

Jay Flanagan

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Security Mini-Conference

5

Security Mini-Conference

•http://it.emory.edu/security_conference_2006

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SANS Training

• If we could bring a SANS Security Training class like Hacker Techniques, Exploits & Incident Handling would you be interested in attending?– Trying to get the cost down to 600.00 per person

• Working to host with GSU, Ga. Tech and UGA

eResearch at EmoryPhase I: eIRB

John Wilson

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• eResearch overview• Project Timeline• eResearch at Emory – Information Sharing

• eResearch Application Architecture• Summary• Questions

Agenda

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ClickCommerce eResearch at Emory

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Application OvervieweResearch at Emory will automate and streamline the current workflow.

• Paper based submission of protocols makes for a cumbersome review process

• High cost associated with document duplication and shipping

• Redundant requests for protocol status

• Manual workflow management processes has a potential audit trail risk

• Limited scale with current desktop database repository

Current Condition Future State with eResearch at Emory

•Web browser-based submission of protocols•Secure access for authorized users•System customizable workflow routing, approval, and documentation processes•Virtual document storage •Centralized meeting management tools and email notifications•Online real-time 24x7 system access for protocol management•Improved information sharing across committees; e.g. OSP, EHSO, COI etc.

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We are targeting early summer 2006 to implement eIRB for new study submissions.

Project Timeline

Install hardware

Build technical infrastructure

Build smart forms

Build workflows

Alpha testing

Initial Roll-Out eIRB

Develop training plans

Jan’ 06 Feb ’06 Mar ’06 Apr ’06 May ’06 Jun ’06 Jul ’06

Final revisions and tests

Validate requirements

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eResearch at Emory University

The many departments/entities that interact with the IRB for protocol information can realize benefits from the eResearch solution.

Emory Health Safety Office(EHSO)

>In: Notice-protocol w/EHSO governed agent

>Out: EHSO Approvals

Siteworks – Clinical Trials System (CTO)

>In: Specific Protocol Info>Out: Nothing

Childrens Healthcare of Atlanta (CHOA)

>In: IRB Approvals>Out: Nothing

Winship Cancer Institute (WCI)

>In: IRB Approvals>Out: WCI Approvals

Office of Sponsored Programs

(OSP)>In: IRB Approvals

>Out: Funding Agency List

Human Embryonic Stem Cell

Committee(HESC)

TBD

Emory University Office of Research Compliance

(ORC)

Powerchart>In: Personnel on protocols

+ Approval period>Out: Nothing

General Clinical Research Center (GCRC)

>In: IRB Approvals>Out: Nothing

Grady Research Oversight Committee (GROC)>In: IRB Approvals

>Out: Nothing

Conflict of Interest Committee

(COI)>In: Specific Protocol Info

>Out: COI Approvals

ClickCommerce V 5.5Institutional Review Board (IRB) Management System

(Phases: 1 = IRB; 2 = IACUC; 3 = EHSO; 4 = COI)

Access/Security>LDAP: EMU + EHC

>Application Only

Resource Data>Human Resources

>FAS: COA + Hierarchy(Data Warehouse)

ID, Title, PI, Approve Dt, Expire Dt, Staff with Certification

ID, Title, PI, Approve Dt, Expire Dt

Staff associated to approved studies

ID, Title, PI, Approve Dt, Expire Dt, Staff with Certification

ID, Title, PI, Approve Dt, Expire Dt, Staff with Certification

ID, Title, PI, governed agent info

ID, Title, PI, Approve Dt, Expire Dt, Staff with Certification

ID, Title, PI, Approve Dt, Expire Dt

Access to specified information based on strict criteria:WCI – Studies dealing with cancer onlyCHOA – Studies with CHOA as a site onlyCTO – Studies that involve drug or devices – Clinical Trials onlyEHSO – Studies that involve governed agents onlyOSP – Studies that involve funding onlyGROC – Studies with Grady as a site onlyGCRC – Studies with GCRC as a site onlyHESC – Studies dealing with human embryonic and stem cell

Access to information to be provided in report form with NO drill-down to additional information

Will be re-addressed after system is implemented.

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eResearch Architecture

University Network 170.

University Administrative CoreUniversity DMZ

SQL(PROD)

SQL(QA, DEV)

TSM Backups

eResearch Applicaion/Web servers

All users

eResearch Architecture(University Network)

Red = ePHI

(PROD)

(QA, DEV)

Net ContinuumWeb application firewall

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eResearch at Emory Future

• Full implementation of all modules: eIRB, eIACUC, eEHSO and eSOMCOI

• Ability to share information with other Emory research areas

• Expandable management reporting repository• Links to appropriate Emory, federal, state, foundations and private charity websites

• Enhanced compliance requirements tracking resulting in reduced audit risk

• Availability of historical information on active protocols

• New reporting capabilities and reporting access availability

The application is a component of a enterprise-wide electronic research administration system.

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eResearch

?Questions

Housing Overview & Demonstration

Heather Mugg