1. Introduction of an IRB Electronic Submission and Archiving System Seong Ho Moon IRB Coordinator, International Vaccine Institute

2. Contents Introduction of the IVI Background Objectives Steps of development Process Results Conclusions Review

3. Introduction of the IVI The International Vaccine Institute (IVI)

4. Background (1) To reduce costs/time/effort comes from paper- based system To improve user accessibility To consider the environment “Paperless” has emerged as an important issue

5. Background (2) Initial Plan (Three options) -Buy an off-the-shelf purpose built e-IRB system -Obtain a license for a locally developed e-IRB system -Develop a bespoke system using developers  Not accepted Revised Plan -Given that the Institute already used the MS SharePoint software for collaboration, to try and develop our own electronic IRB system around this software platform

6. Background (3) What is the Microsoft SharePoint? -Microsoft SharePoint is a web application framework and platform developed by Microsoft. Users can use it as a secure place to store, organize, share, and access information from almost any device and web browser Why use the SharePoint? -Already in use at the IVI -Easy to use -Compatibility with the MS office and other commonly used software

7. Objectives Key guiding principles: Make it easier for all users Recognize the limitation of SharePoint

8. Steps of Development (1) Step 1: Establish a project team -Led by the IRB Coordinator and comprising IRB staff and the IVI IT team Step 2: Identify whether SharePoint could be adapted for the e-IRB purpose -Map-out fully the complete end-to-end IRB process -Establish whether each element of the existing largely paper-based IRB system could be carried-out electronically within the SharePoint Step 3: Develop the site -Developing the site by having regular/frequent meetings with the project team to check and monitor the progress of development

9. Steps of Development (2) Step 4: Test and Simulation -Internal tests by the IRB office staff To check workflow and technical error -Simulations with Users Have a role playing with the mock application files in the same room To hear opinions/comments from users -Revise the SharePoint, based on the user’s opinions/comments

10. Steps of Development (3) Step 5: Demonstration to the Board and get their approval -Demonstration to the IRB members at the full board meeting To hear their opinions/comments To get the board’s approval for using this system -Decide a transitional period with key components of the paper-based system continuing in parallel -Revise the SharePoint system, based on member’s feedback

11. Steps of Development (4) Step 6: SOP revision and User training -IRB SOP revision for changes in relation to the submission and archiving -Developing user manual -Provide training sessions to all users, prior to the implementation To provide the manual and instructions to users To provide the SOP revision training

12. Process (1) Flow Chart

13. Process (2) IRB SharePoint Site Main Page

14. Process (3) IRB SharePoint Submission Page

15. Results (1) User Survey was conducted -Response rate: 7/17 -Survey method: Anonymous questionnaire -Survey target: IRB SharePoint User  Investigator: 3  IRB Member: 3  Both: 1 There were no unforeseen problems Follow-up user survey will be conducted

16. Results (2)

17. Conclusions IRB SharePoint was successfully implemented with no major issues Advantages -Reduce Costs/Time/Effort -Improve user accessibility For the IRB members regardless of affiliation  Maintain consistency for assigning reviewers For the Investigators  Enable them to submit IRB applications with no bounds on time and place Limitations -Hybrid system: SharePoint + E-mail -Manual works are required: Permission management

18. Review The SharePoint electronic submission, review and archiving system developed here may have applications for other IRBs, particularly for those with: -A relatively low number of submissions handled -Insufficient funding available to purchase a fully functioning e-IRB system -MS SharePoint already used in-house

19. Acknowledgements Core Support: IRB Office -Dr. Greg Smith (the former IVI IRB Coordinator) -Ms. Hyun A Cho (IVI IRB Administrator) Technical Support: IT Unit -Mr. Vinay Kumar Gupta (IVI IT Chief) -Mr. Jin Hyouk Choi (IVI IT Application Developer) General Support: -IRB Members -Institutional investigators and research staff -Senior Management

20. Thank you for your attention If you have any questions, you can contact me by e-mail (seonghomoon@ivi.int).