Upload
anastasia-campbell
View
215
Download
0
Embed Size (px)
Citation preview
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?