eResearch at Emory Phase I: eIRB Date: 4/20/06 2/16/2019 8:08 AM 1

Table of Contents What is eResearch? Benefits of eResearch What is the eIRB? eIRB Study Review Process New Study Application Overview eResearch Application Principle Investigator Home Workspace New Study Submission Form Application Principle Investigator Study Workspace Department and Division Head Workspace Department and Division Head Study Workspace Project Timeline Training Opportunities 2/16/2019 8:08 AM 2

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. 2/16/2019 8:08 AM 3

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 email notifications Online real-time 24x7 system access for protocol management Many electronic integration points; e.g. IRB, IACUC, EHSO, COI etc. 2/16/2019 8:08 AM 4

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. 2/16/2019 8:08 AM 5

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. 2/16/2019 8:08 AM 6

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 2/16/2019 8:08 AM 7

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 HIPPA/PHI Views 1 PHI 2 HIPAA 1 3 HIPAA 2 2/16/2019 8:08 AM 8

Study Team Home Workspace 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. 2/16/2019 8:08 AM 9

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. 2/16/2019 8:08 AM 10

PI Study Workspace 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. 2/16/2019 8:08 AM 11

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. 2/16/2019 8:08 AM 12

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. 2/16/2019 8:08 AM 13

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 2/16/2019 8:08 AM 14

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 2/16/2019 8:08 AM 15

Training Opportunities Starting in May, various resources for training will be available. Schedules are being finalized and will be made public for open lab times and in-depth training sessions. IRB Home Page Downloads Available: On-line Training Slides, Open lab schedules, quick reference guides and user manuals Open Lab A workshop lab will be open during specified times for hands on 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 2/16/2019 8:08 AM 16