eResearch at Emory Phase I: eIRB

1. eResearch at EmoryPhase I: eIRB Date: 05/16/06 1

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 • Training Opportunities 2

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. 3

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 • 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 email notifications • Online real-time 24x7 system access for protocol management • Many electronic integration points; e.g. IRB, IACUC, EHSO, COI etc. • 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 4

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. 5

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: • http://it.emory.edu/showdoc.cfm?docid=1086&fr=1070 6

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 ’06 May ’06 Jun ’06 Jul ’06 Aug ’06 Sept ’06 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 7

8. IRB Home Page Training/Open Lab eResearch training site Training Opportunities Starting in May, various resources for training will be available. Downloads Available: On-line Training Slides, Open lab schedules, quick reference guides and user manuals A workshop lab will be open during specified times for hands on training as well as guidance without formal instruction. 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 8

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. 9

10. Pre-IRB Reviewers • Department or Division Head • Faculty Advisor • Winship Cancer Institute • Human Embryonic Stem Cell • 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 Reviewers verify relevant sections of the study, request and obtain additional information from the study team, and issue their approval through the system 3. Review Study 2. Route Study 4. Accept Study 7. Approved Study 6. Finalize Decision 5. Process Study Depending on study answers, system automatically routes study to non - IRB Reviewers: • EHSO Biosafety • EHSO Radiation Safety • SOMCOI Once Pre-IRB reviewers have given their approvals, the study is received by the IRB Staff for processing 1. Create Study eIRB Study Review Process 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 With approved studies Study Team can: • Conduct research • Report events • Submit Amendments • Submit Continuing Review • Request Terminations PI/Study Coordinator submits eIRB study application 10

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. 11

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. 12

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. 13

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. 14

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. 15

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. 16

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. 17

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. 18

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. 19

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. 20

21. Training/Open Lab Open Lab Training Schedule Starting in May, various resources for training will be available. • 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 requiredTo schedule group training, contact the IRB 21

22. Contact Information eResearch at EmoryPhase I: eIRB eResearch@emory.edu 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 22