update on the enterprise initiative: e-irb and more riyad naser, ms, mba director of research...

Update on the Enterprise Initiative: e-IRB and MoreRiyad Naser, MS, MBADirector of Research Information Systems

Karen Blackwell, MS, CIPDirector, Human Research Protection Program

CRIS Enterprise Initiative

•Initiative Goals•Initiative Components•Where We Are

▫GCRC Implementation▫RI Implementation▫E-IRB

Initiative Goals

•Standardize our processes•Integrate research with clinical practice

•Integrated disciplines / departments

•Improve data quality•Improve operational efficiency•Facilitate inter-institutional collaboration

CRIS ENTERPRISE INITIATIVE

Phase I (Implementati

on)

Department Rollout

E-Budget

E-IRB

Phase II (Integration)

E-Budget

Lab / Demograp

hics

Phase III

E-Sample/IACUC

Dependencies

PeopleSoft / EHR

CRIS Enterprise Initiative

CRIS ENTERPRISE INITIATIVE TIMELINE

Phase I (Implementation)

Phase II (Integrati

on) Phase III

10/08-12/09 05/10-12/10

Initiative Timeline

Approaching the Enterprise

•Enterprise Level

•Department Level

•Vendor Level

Phase I (Implementation)

Dept. Rollout

E-Budget

E-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?

Current Hardware Environment

Standardizing Plan

•GCRC protocol and patient management

•CReDO regulatory office•E-IRB Process

CReDO regulatory office

•Have a very detailed tracking system

•Capture research data in CRIS early on

•Manage their expectations

CReDO regulatory office..Migration

Description Number

Studies imported into CRIS from Research Institute (RI) 424

Imported IRB statuses into CRIS from RI database 460

Sponsor Protocol Numbers imported into CRIS 484

Studies activations form imported 368

Adverse events imported in the system 3170

Amendment Information Imported 1638

Initial IRB Submissions Imported 513

Imported Protocol Recertification 991

Total records imported 8048

E-IRB•What?

•Why?

•How?

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”

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

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

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

Benefits on All Levels

•Advantages for Investigators•Improvements for Compliance•Advantages for the Institution

Current StateIRB 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

CRIS

Future State: e-IRB

E-IRB –Submitting a new application

E-IRB –Completeness check

E-IRB –Pending Items

E-IRB –Ongoing Studies

E-IRB………Manage Submissions

E-IRB………Reviewer Area

E-IRB………Manage Meetings

E-IRB Next Steps…

•Testing Phase•Migration•Go Live

▫Phase Approach▫“Cold Turkey” Approach

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.

QUESTIONS?