1. eResearch at Emory Phase I: eIRB
Date: 4/27/06
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2. Table of Contents What is eResearch? Benefits of eResearch
What is the eIRB?
Access to eResearch
Project Timeline
Training Opportunities
Roles in the IRB Review Process
eIRB Study Review Process
New Study Application Overview
Study Team Home Workspace
New Study Submission Form
Study Team Study Workspace
Department and Division Head Workspace
Department and Division Head Study Workspace
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3. What is eResearch?
Our vision is for eResearch to streamline research submissions and processing at Emory University.
eResearch is a Web-based system for submission, workflow, approval and management of research information.
Initially, the system will be used for NEW research studies involving human subjects.
The system will assist the University in standardizing the method in which human research studies are submitted, processed and reviewed.
The system will be a tool to facilitate compliance with relevant government regulations and to bring transparency to the application review process.
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4. Benefits of eResearch
We have assessed the current state processes for various oversight committees and have selected a software application to automate and streamline the current workflow.
Future State with
eResearch at Emory
Current Condition
Paper based submission of protocols associated with long processing time
High cost associated with document storage and shipping
Redundant requests of protocol status
Manual workflow management processes has a potential audit trail risk
Limited scale with desktop database repository
Web browser-based submission of applications
Secure access for authorized users
System customizable workflow routing, approval, and documentation processes
Virtual document storage
Centralized meeting management tools and notifications
Online real-time 24x7 system access for protocol management
Many electronic integration points; e.g. IRB, IACUC, EHSO, COI etc.
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5. What is eIRB?
eIRB is the first module of the eResearch project and will be the vehicle for the IRB to streamline their business processes for handling NEW research studies with human subjects.
The IRB’s role will remain the same, the method in which they accept and manage protocol applications will change.
The system will be the tool used by the IRB to:
Collect study information
Schedule study reviews and studies to IRB meetings
Communicate study requests and status to the study team
The eIRB module consists of 5 projects:
Study
Continuing Review
Amendment
Reportable Events
Termination
The study project will be the first project of the eIRB module to be made available to the research community.
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6. Access to eResearch
Due to HIPPA regulations login procedures to eResearch will be different than other Emory University applications.
The login id will be the same as the user’s network id.
The password will be different from the network id’s password.
The password must be a combination of 8 numbers and characters.
Passwords will expire every 90 days.
eResearch will adhere to Emory University’s network ID policies:
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7. Project Timeline
We are targeting early summer 2006 to implement the eIRB module for new study submissions. Once a new study has been submitted, all subsequent activities related to that study will be done in the application.
Apr ’ May ’06 Jun ’ Jul ’ Aug ’06 Sept ’ Oct ’06
eResearch Intro Presentations
Alpha Testing
IRB Staff Training
Paper Studies No Longer
Accepted: July 5, 2006
Research Community Training
Open Lab Sessions
eResearch eIRB module Go-Live: June 5,2006
New Study Paper Submissions
New Study Electronic Submissions
Continuing Review Paper Submissions
Continuing Review Electronic Submissions
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8. Training Opportunities
Starting in May, various resources for training will be available.
IRB Home Page
Downloads Available: On-line Training Slides, Open lab schedules, quick reference guides and user manuals
Training/Open Lab
A workshop lab will be open during specified times for hands on training as well as guidance without formal instruction.
eResearch training site
The eResearch training site will be available for users to practice on their own. Information to access the site will be available from the IRB website
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9. Roles in the IRB Review Process
There are several different people involved in the creation and processing of an IRB project. Roles have been identified and given various activities within the new application.
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10. eIRB Study Review Process
4. Accept Study
5. Process Study
Once Pre-IRB reviewers have given their approvals,
the study is received by the IRB Staff for processing
IRB staff manages the review process using eResearch
Request further information
Determine review method
Assign reviewers
Schedule study for IRB meetings
Accept non-IRB approvals
3. Review Study
Reviewers verify relevant sections of the study,
request and obtain additional information from the study
team, and issue their approval through the system
6. Finalize Decision
IRB Committee members conduct reviews
IRB Committee decisions and minutes are recorded
IRB Staff prepare letters with IRB motions
Study team receives decisions
Schedule study for IRB meetings
2. Route Study
Depending on study answers, system automatically
routes study to non - IRB Reviewers:
EHSO Biosafety
EHSO Radiation Safety
SOMCOI
Pre-IRB Reviewers
Department or Division Head
Faculty Advisor
Winship Cancer Institute
Human Embryonic Stem Cell
7. Approved Study
With approved studies Study Team can:
Conduct research
Report events
Submit Amendments
Submit Continuing Review
Request Terminations
1. Create Study
PI/Study Coordinator submits eIRB study application
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11. Study Team Home Workspace - Inbox
The home workspace with the eResearch application displays all the eIRB study submissions associated with the logged in user. The inbox tab contains submitted studies that require action by the user.
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12. Study Team Home Workspace – IRB Tab
The home workspace with the eResearch application displays all the eIRB study submissions associated with the logged in user. The IRB tab contains submitted studies the user is associated with regardless of where it is in the process.
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13. New eIRB Submission Application
The new on-line submission form requires the same information to be input as on the old written form; however, it has smart-form capabilities and answers to certain questions will serve as prompts for additional information to be collected.
Required Sections - Views 1
Study Identification 2
Required Reviews 3
Study Sites 4
Funding 5
Research Design 6
Research Type 7
HIPAA 8
IRB Miscellaneous Documents 9
Final Page
Social/Population Views 1
Social Research 2
Study Population 3
Recruitment
Normal Volunteers
Minors 4
Students 5
Patients 6
Emory Employees 7
Women 8
Prisoners 9
Cognitively Impaired 10
Non-English 11
Informed Consent Process 12
Data Safety Monitoring Plan
Clinical Views 1
Biomedical Research 2
Banking 3
Clinical Trials - Device 4
Clinical Trials - Drugs
External Committee Views 1
Conflict of Interest 2
Human Embryonic Stem Cell 3
EHSO-Bio Safety 4
EHSO-Rad Safety
HIPAA/PHI Views 1
PHI 2
HIPAA 1 3
HIPAA 2
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14. New Study Identification View
By clicking the New Study button on the home workspace, a submission form is created. The principal investigator field is pre-populated with the logged in user’s name.
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15. PI Study Workspace – Pre Submission
Once a submission form is completed, the user is taken to the new study workspace where the user can perform activities related to the study and view the history log and status.
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16. PI Study Workspace – Changes required
If a submission is returned for changes, the user is taken to the new study workspace where the user can perform activities related to the study and view the history log and status.
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17. PI Study Workspace – Approved
Once a study is approved, the user is taken to the new study workspace where the user can perform activities related to the study and view the history log and status.
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18. PI Study Workspace – Approved
Once a study is approved, the user is taken to the new study workspace where the user can perform activities related to the study and view the decision letter.
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19. Dept/Div Approver Home Workspace
The My inbox tab within the application displays all the eIRB study submissions that require the logged in department head’s approval. By clicking on the study name, the user can see the study.
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20. Dept/Div Approver Study Workspace
The study workspace displays details of the eIRB study submission. The approver can view the study, request changes from the study team and issue the departmental approval.
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21. Open Lab Training Schedule
Starting in May, various resources for training will be available.
Training/Open Lab
A workshop lab will be open during specified times –
The 1st hour will be instructor led training, The 2nd hour will be an open lab
Monday 4:00 PM – 6:00 PM
Thursday 8:00 AM – 10:00 AM
Friday 11:00 AM – 1:00 PM
Registration will be required To schedule group training, contact the IRB
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22. eResearch at Emory Phase I: eIRB
Contact Information
eResearch at Emory Phase I: eIRB
Project Team:
Tanya Sudia Robinson PhD
Director, IRB/IACUC Office
John B Wilson Jr. MBA/PMP
Project Manager, AAIT
Christine Gomez
Sr. Desktop Consultant, IRB/IACUC Office
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