1. Introduction to INSPIR OCR Seminar Series January 21, 2004 Mary Banks, RN Administrator, Office of the IRB

2. “The Future Is Now” Yogi Berra

3. What is INSPIR ? Integrated Network for Subject Protection In Research

4. INSPIR Background Developed as BRAIN at Baylor School of Medicine Developed as BRAIN at Baylor School of Medicine Currently used at Baylor and University of Maryland (BRAAN) Currently used at Baylor and University of Maryland (BRAAN) Result of IRB Improvement Grant (NIH) Result of IRB Improvement Grant (NIH) Customized to fit Boston University requirements Customized to fit Boston University requirements Will be used at BUMC and Charles River Campus Will be used at BUMC and Charles River Campus Used by BUMC IRB and IACUC Used by BUMC IRB and IACUC

5. System Requirements January Issue of CR Times (www.bu.edu/crtimes)- link January Issue of CR Times (www.bu.edu/crtimes)- linkwww.bu.edu/crtimes)- Connecting to INSPIR Connecting to INSPIR Browser Browser –Macintosh, Netscape version 7 –Safari for Mac –PC- Internet Explorer 6.0 or higher Cookies must be enabled Cookies must be enabled Pop-up Blockers must be disabled Pop-up Blockers must be disabled www.bumc.bu.edu/Departments/PageMain.asp?Page=8725&DepartmentID=368

6. Useful Tip Attachments (drug brochures, sponsor’s protocol, grant applications) will have to be scanned and “attached” to the IRB application Attachments (drug brochures, sponsor’s protocol, grant applications) will have to be scanned and “attached” to the IRB application Extremely helpful if you have a scanner within the department to use to scan these documents Extremely helpful if you have a scanner within the department to use to scan these documents

7. Access to INSPIR Website “Getting Access” Website “Getting Access” Presence in BU’s electronic directory Presence in BU’s electronic directory BU Login Name, BUID Number, and Kerberos password BU Login Name, BUID Number, and Kerberos password If you don’t have a presence in BU’s directory (BMC, VA) instructions available If you don’t have a presence in BU’s directory (BMC, VA) instructions available Do this now- don’t wait Do this now- don’t wait www.bumc.bu.edu/Departments/PageMain.asp?Page=8636&DepartmentID=368

8. Difficulties Logging Into INSPIR Login issues and technical issues will NOT be managed by the IRB office Login issues and technical issues will NOT be managed by the IRB office Contact the IT INSPIR Team at BRAAN@bu.edu Contact the IT INSPIR Team at BRAAN@bu.eduBRAAN@bu.edu Helpful advice on website under “Help!” Helpful advice on website under “Help!” www.bumc.bu.edu/Departments/PageMain.asp?Page=8094&DepartmentID=368

9. What Does INSPIR Do? Allows for IRB protocols to be created, routed, reviewed, signed, and approved within the system Allows for IRB protocols to be created, routed, reviewed, signed, and approved within the system Provides for transparent processing- everyone who has access can see where the protocol is at each step in the process Provides for transparent processing- everyone who has access can see where the protocol is at each step in the process Creates IRB meeting agendas and minutes Creates IRB meeting agendas and minutes Gives reviewers and investigators access to the entire study file (including previous versions that are archived in the system) Gives reviewers and investigators access to the entire study file (including previous versions that are archived in the system) Automatically generates continuing review reminders Automatically generates continuing review reminders

10. Why Be INSPIRed? Electronic submission of protocols Electronic submission of protocols –No longer need to submit multiple copies to IRB –Not rely on interdepartmental mail –No need to hand deliver documents to the IRB office –Documents won’t get lost –Accurate study files- investigator files will match IRB files

11. Why Be INSPIRed? (cont.) Investigators can track the progress of own protocols Investigators can track the progress of own protocols Multiple copies of documents (approval letters, consent forms, etc.) with version control can be printed Multiple copies of documents (approval letters, consent forms, etc.) with version control can be printed Applications are automatically routed for required signatures Applications are automatically routed for required signatures Continuing Review process is much easier because amendments, SAEs, etc. are cumulatively tracked Continuing Review process is much easier because amendments, SAEs, etc. are cumulatively tracked Investigators can access INSPIR from any internet connected computer Investigators can access INSPIR from any internet connected computer

13. JanFebMar April May summer 3/8 - 3/15 IRB office CLOSED 2/23 - 3/15 Train the Investigators Mar. 8 IRB office Stops Accepting Paper Mar. 15 GO LIVE 2004

14. Important Dates for Investigators and Research Staff at BUMC February 23 - March 15 February 23 - March 15 Investigator training March 8 March 8 IRB Office stops accepting paper submissions March 8 - 15 March 8 - 15 IRB Office closed March 15 March 15 Go Live Date

15. Investigator Training Feb. 23 - Mar.15 Feb. 23 - Mar.15 Training will include Training will include –Online training –Investigator Manual –Large group classes –Small group classes Schedule of classes will be posted Schedule of classes will be posted Practice site will be available for investigators to use Practice site will be available for investigators to use

16. IRB Office Stops Accepting Paper March 8, 2004 March 8, 2004 All paper Progress Reports must be submitted by this date All paper Progress Reports must be submitted by this date Can submit Progress Reports for March, April and May Can submit Progress Reports for March, April and May Last date to accept new Research Applications in paper Last date to accept new Research Applications in paper Last date to accept amendments in paper Last date to accept amendments in paper

17. IRB OFFICE CLOSED March 8-15 March 8-15 No paper or electronic submissions accepted during this week No paper or electronic submissions accepted during this week Investigator training will be ongoing during the week Investigator training will be ongoing during the week IRB office staff will be available for training and to answer questions IRB office staff will be available for training and to answer questions

18. GO LIVE March 15, 2004 March 15, 2004 First day protocols can be submitted electronically First day protocols can be submitted electronically –New protocols –Progress Reports (Continuing Reviews) –Amendments

19. New IRB Applications Full Board, Expedited and Exempt Full Board, Expedited and Exempt Submit on paper by March 8 OR Submit on paper by March 8 OR Must hold and submit on or after March 15 electronically Must hold and submit on or after March 15 electronically Investigators can work on drafts prior to March 15 Investigators can work on drafts prior to March 15

20. Continuing Review Progress Reports must be submitted by March 8 on paper OR Progress Reports must be submitted by March 8 on paper OR Must be held until March 15 for submission electronically Must be held until March 15 for submission electronically Investigators may submit on paper for March, April, May only Investigators may submit on paper for March, April, May only Studies that expire after May 31, 2004 – Progress Reports must be submitted electronically Studies that expire after May 31, 2004 – Progress Reports must be submitted electronically

21. Continuing Review After March 8 all Progress Reports (CRs) must be submitted electronically After March 8 all Progress Reports (CRs) must be submitted electronically To submit a Progress Report the investigator must first enter the study into the system using a new application To submit a Progress Report the investigator must first enter the study into the system using a new application

22. Continuing Review If PI submits a new protocol on March 8 on paper - will have to re-submit the study electronically at time of next Continuing Review If PI submits a new protocol on March 8 on paper - will have to re-submit the study electronically at time of next Continuing Review Investigators must ensure that studies will not lapse Investigators must ensure that studies will not lapse Progress Reports must still be submitted at least 5 weeks prior to expiration Progress Reports must still be submitted at least 5 weeks prior to expiration

23. Amendments After March 8 all amendments must be submitted electronically After March 8 all amendments must be submitted electronically Prior to submitting an amendment the investigator must enter the protocol into the system (by completing a Research Application for the study) Prior to submitting an amendment the investigator must enter the protocol into the system (by completing a Research Application for the study)

24. Serious Adverse Events March 8 deadline does not apply to SAEs March 8 deadline does not apply to SAEs SAEs may be submitted on paper until the study is up for Continuing Review (or an amendment is needed) SAEs may be submitted on paper until the study is up for Continuing Review (or an amendment is needed) More information on SAEs will be coming - the IRB is modifying the policy on submitting SAEs to the IRB More information on SAEs will be coming - the IRB is modifying the policy on submitting SAEs to the IRB

25. Demonstration of INSPIR Demonstration site (practice site) will be available soon for use by investigators Demonstration site (practice site) will be available soon for use by investigators Final modifications being made to the system Final modifications being made to the system We will provide investigators paper copies of screen shots We will provide investigators paper copies of screen shots We will provide an electronic Investigator’s manual We will provide an electronic Investigator’s manual

26. Go To Demo