INSPIR Training Guidelines and Submission Procedures for BUMC Researchers

1. Welcome To INSPIR Training • Please be sure to sign- in • Please be sure you try to log –on to INSPIR before you leave • Please be sure that you get a handout

2. Let Me INSPIR You INSPIR Training Mary Banks RN Administrator BUMC Office of the IRB

3. 2004 summer April Jan Feb Mar May Mar. 8 IRB office Stops Accepting Paper Mar. 15 GO LIVE 3/8 - 3/15 IRB office CLOSED 2/18 INSPIR Training 2/23 - 3/15 Train the Investigators

4. Clarification Paper protocols • Refer to status of all current IRB studies • Whether submitted by paper, fax, email, etc. Electronic submission • Refer to studies in INSPIR

5. Migrating Data to INSPIR • Active studies from the current IRB database • With no PENDING issues (no outstanding amendments, no conditional approvals or deferrals) • PI has to be in INSPIR database • Before March 15, 2004 • Limited information will be transferred to INSPIR electronically • Study will receive a new INSPIR study number (H-XXXXX) • Old IRB number will be included in the title field (searchable) • All other fields in the database must be populated by the investigators

6. IRB Office Stops Accepting Paper Monday March 8, 2004 • All study materials (paper, fax, email) must be submitted before this date • except SAEs/safety reports/deviations • Can only submit Progress Reports for March, April and May • Last date to accept new Research Applications in paper • New applications submitted in paper will have to be converted to INSPIR

7. IRB OFFICE CLOSED March 8-15, 2004 • No paper or electronic submissions will be accepted during this week • IRB Office will be working on the data migration activities

8. GO LIVE March 15, 2004 • Ides of March • First day protocol materials can be submitted electronically using INSPIR • New protocols • Progress Reports (Continuing Reviews) • Amendments • SAEs

9. When Can I Access My Study In INSPIR? All Approved Protocols (with no pending amendments and CRs are up to date) • Limited study information will be migrated to INSPIR by March 15 • Then all study documents (that were not submitted in paper before March 8) must be submitted electronically • SAEs can still be submitted in paper until the study is fully converted to INSPIR

10. When Can I Access My Study In INSPIR? All Expired Protocols will be closed and cannot be migrated to INSPIR. • past expiration date without CR or • outstanding conditional approval /deferral >90 days) To prevent this from happening you must respond to the Expiration/ 90 day warning email from the IRB prior to March 2, 2004

11. When Can I Access My Study In INSPIR? All currently PENDING Protocols (with pending amendments or CA/deferrals <90 days) • Cannot be migrated to INSPIR until all PENDING issues are resolved IN PAPER- will not have a presence in INSPIR until pending issues resolved • After pending issues resolved these studies will be migrated to INSPIR • PI must respond to these CA/deferrals before 90 days or these studies will be closed

12. Components of INSPIR to be Covered Today • Logging – on • Roles (investigator, PI) • View Protocols screen • Individual protocol screens • Set Privileges • Entering new studies into INSPIR • Converting approved studies to INSPIR

13. Check Ability to Log In to INSPIR • Use your BU user name as your log-in name • Use your BU/ Kerberos password as your password • Click log-in Go to https://braan.bumc.bu.edu/brainlogin.asp

16. Problems with Logging On • Need a presence in the BU Active Directory as BU employee or guest • Registered for INSPIR • Browser settings correct

21. Troubleshooting Log-on Problems • Make sure you have the correct website • Browser settings • Using BU user name and password • Go to INSPIR page for help www.bumc.bu.edu/inspir

22. INVESTIGATOR Role • Applies to ALL members of the research staff (PI, study coordinators, data managers, research nurses, co-investigators) • For each study a PI is identified in the system • For each study the PI determines who may view and /or modify the protocol (using Set Privileges function) • Only the investigator who is named the PI on a study has access to the SUBMIT button • Will not be able to assign a study to a PI who is not in the INSPIR database

24. SUBMIT Function • Only the PI can submit new protocols, Progress Reports (CR), and amendments • Any investigator with read/write privileges can submit SAEs, deviations, exceptions • Ability to submit is determined by • PI status on the study • Submit privileges in the system • If PI is unable to “submit” contact the IRB office

25. Submission Control • Using the “submit” button = PI signature • Only the PI can submit items that alter the “approved” version of the protocol • BU policy against giving out password to anyone • IRB policy is that only the PI is allow to submit /change protocol • All other members of the research staff should NOT submit • PI has access from any internet site

28. View Protocols • Overview of all of your studies • Divided up into “piles” • Red stars next to studies that require attention (pending issues) • Can also see studies where you are co-investigator or research staff if the PI has granted read privileges to you • Studies will appear as Human (draft form) or with H-number (if submitted) • Old IRB number will be included in the title-searchable field • Can see when approval expires for each study

30. Protocol Page • From View Protocol page – click onto a protocol • Opens up that protocol to cover page- displays overall info • Select from drop down “What do you want to do” menu

33. Set Privileges • From Protocol Page • “What do you want to do?” drop down • Select “set privileges” • Can add others to read only or read write • Also determine who will get email notifications

35. Entering New Studies into INSPIR • Will have to “take human exam” the first time • PI may initiate study • Coordinator can initiate study- default PI must be changed (PI must be in INSPIR database) • Coordinator should then grant privileges to himself/herself to be able to access that study again --read/write privileges • Can copy from other protocol (if you have access)

44. Conversion of Approved Studies to INSPIR • Can do a conversion amendment at any point- must do before submitting another amendment or a Progress Report • Locate in View Protocols- initially only the PI will have access to the protocol • Studies listed under the incorrect PI will be hard to locate • Will have H number (INSPIR protocol number) • Will have only minimal fields completed

45. Conversion of Approved Studies to INSPIR • Open study • Create amendment-select conversion to INSPIR • Open protocol (IRB application) • Complete like a new application • Create consent form • Submit (no signatures necessary) • Once conversion is approved then you can submit additional amendments / Progress Report

48. Convert to INSPIR-Special • Interventional studies in Long-term follow-up or data analysis phase • No ongoing interventions • Not necessary to enter entire study into INSPIR • Study will become “Long-term FU of Study 2001-XXX “ • Directions will be posted on IRB website

49. What You Can Do To Prepare For INSPIR • Register for INSPIR training –go to www.bumc.bu.edu/irb • Make sure everyone can log-on • Make sure all the studies that you currently have are listed under the correct PI – email Roz@bu.edu for a list • Close out all studies that have been completed BEFORE March 8th • Contact study sponsors for electronic versions of the sponsor’s protocol • Respond to all PENDING protocols (deferrals and conditional approvals) immediately