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Welcome To INSPIR Training Please be sure Please be sure to sign- in to sign- in Please be sure you try to log – on to INSPIR before you leave Please be sure you try to log – on to INSPIR before you leave Please be sure that Please be sure that you get a handout you get a handout
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Let Me INSPIR You INSPIR Training Mary Banks RN Administrator BUMC Office of the IRB
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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 2/18 INSPIR Training
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Clarification Paper protocols Refer to status of all current IRB studies Refer to status of all current IRB studies Whether submitted by paper, fax, email, etc. Whether submitted by paper, fax, email, etc. Electronic submission Refer to studies in INSPIR Refer to studies in INSPIR
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Migrating Data to INSPIR Active studies from the current IRB database Active studies from the current IRB database With no PENDING issues (no outstanding With no PENDING issues (no outstanding amendments, no conditional approvals or deferrals) amendments, no conditional approvals or deferrals) PI has to be in INSPIR database PI has to be in INSPIR database Before March 15, 2004 Before March 15, 2004 Limited information will be transferred to INSPIR electronically Limited information will be transferred to INSPIR electronically Study will receive a new INSPIR study number (H- XXXXX) Study will receive a new INSPIR study number (H- XXXXX) Old IRB number will be included in the title field (searchable) Old IRB number will be included in the title field (searchable) All other fields in the database must be populated by the investigators All other fields in the database must be populated by the investigators
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IRB Office Stops Accepting Paper Monday March 8, 2004 All study materials (paper, fax, email) must be submitted before this date 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 Can only 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 New applications submitted in paper will have to be converted to INSPIR New applications submitted in paper will have to be converted to INSPIR
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IRB OFFICE CLOSED March 8-15, 2004 No paper or electronic submissions will be accepted during this week No paper or electronic submissions will be accepted during this week IRB Office will be working on the data migration activities IRB Office will be working on the data migration activities
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GO LIVE March 15, 2004 Ides of March Ides of March First day protocol materials can be submitted electronically using INSPIR First day protocol materials can be submitted electronically using INSPIR –New protocols –Progress Reports (Continuing Reviews) –Amendments –SAEs
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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 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 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 SAEs can still be submitted in paper until the study is fully converted to INSPIR
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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 past expiration date without CRor outstanding conditional approval /deferral >90 days) 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
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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 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 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 PI must respond to these CA/deferrals before 90 days or these studies will be closed
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Components of INSPIR to be Covered Today Logging – on Logging – on Roles (investigator, PI) Roles (investigator, PI) View Protocols screen View Protocols screen Individual protocol screens Individual protocol screens Set Privileges Set Privileges Entering new studies into INSPIR Entering new studies into INSPIR Converting approved studies to INSPIR Converting approved studies to INSPIR
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Check Ability to Log In to INSPIR Use your BU user name as your log-in name Use your BU user name as your log-in name Use your BU/ Kerberos password as your password Use your BU/ Kerberos password as your password Click log-in Click log-in Go to https://braan.bumc.bu.edu/brainlogin.asp
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Problems with Logging On Need a presence in the BU Active Directory as BU employee or guest Need a presence in the BU Active Directory as BU employee or guest Registered for INSPIR Registered for INSPIR Browser settings correct Browser settings correct
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Troubleshooting Log-on Problems Make sure you have the correct website Make sure you have the correct website Browser settings Browser settings Using BU user name and password Using BU user name and password Go to INSPIR page for help www.bumc.bu.edu/inspir Go to INSPIR page for help www.bumc.bu.edu/inspir
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INVESTIGATOR Role INVESTIGATOR Role Applies to ALL members of the research staff (PI, study coordinators, data managers, research nurses, co-investigators) 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 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) 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 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 Will not be able to assign a study to a PI who is not in the INSPIR database
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SUBMIT Function Only the PI can submit new protocols, Progress Reports (CR), and amendments Only the PI can submit new protocols, Progress Reports (CR), and amendments Any investigator with read/write privileges can submit SAEs, deviations, exceptions Any investigator with read/write privileges can submit SAEs, deviations, exceptions Ability to submit is determined by 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
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Submission Control Using the “submit” button = PI signature Using the “submit” button = PI signature Only the PI can submit items that alter the “approved” version of the protocol Only the PI can submit items that alter the “approved” version of the protocol BU policy against giving out password to anyone BU policy against giving out password to anyone IRB policy is that only the PI is allow to submit /change protocol IRB policy is that only the PI is allow to submit /change protocol All other members of the research staff should NOT submit All other members of the research staff should NOT submit PI has access from any internet site PI has access from any internet site
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View Protocols View Protocols Overview of all of your studies Overview of all of your studies Divided up into “piles” Divided up into “piles” Red stars next to studies that require attention (pending issues) 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 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) Studies will appear as Human (draft form) or with H-number (if submitted) Old IRB number will be included in the title- searchable field Old IRB number will be included in the title- searchable field Can see when approval expires for each study Can see when approval expires for each study
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Protocol Page From View Protocol page – click onto a protocol From View Protocol page – click onto a protocol Opens up that protocol to cover page- displays overall info Opens up that protocol to cover page- displays overall info Select from drop down “What do you want to do” menu Select from drop down “What do you want to do” menu
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Set Privileges From Protocol Page From Protocol Page “What do you want to do?” drop down “What do you want to do?” drop down Select “set privileges” Select “set privileges” Can add others to read only or read write Can add others to read only or read write Also determine who will get email notifications Also determine who will get email notifications
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Entering New Studies into INSPIR Will have to “take human exam” the first time Will have to “take human exam” the first time PI may initiate study PI may initiate study Coordinator can initiate study- default PI must be changed Coordinator can initiate study- default PI must be changed (PI must be in INSPIR database) (PI must be in INSPIR database) Coordinator should then grant privileges to himself/herself to be able to access that study again Coordinator should then grant privileges to himself/herself to be able to access that study again --read/write privileges --read/write privileges Can copy from other protocol (if you have access) Can copy from other protocol (if you have access)
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Conversion of Approved Studies to INSPIR Can do a conversion amendment at any point- must do before submitting another amendment or a Progress Report 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 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 Studies listed under the incorrect PI will be hard to locate Will have H number (INSPIR protocol number) Will have H number (INSPIR protocol number) Will have only minimal fields completed Will have only minimal fields completed
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Conversion of Approved Studies to INSPIR Open study Open study Create amendment-select conversion to INSPIR Create amendment-select conversion to INSPIR Open protocol (IRB application) Open protocol (IRB application) Complete like a new application Complete like a new application Create consent form Create consent form Submit (no signatures necessary) Submit (no signatures necessary) Once conversion is approved then you can submit additional amendments / Progress Report Once conversion is approved then you can submit additional amendments / Progress Report
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Convert to INSPIR-Special Interventional studies in Long- term follow-up or data analysis phase Interventional studies in Long- term follow-up or data analysis phase No ongoing interventions No ongoing interventions Not necessary to enter entire study into INSPIR Not necessary to enter entire study into INSPIR Study will become “Long-term FU of Study 2001-XXX “ Study will become “Long-term FU of Study 2001-XXX “ Directions will be posted on IRB website Directions will be posted on IRB website
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What You Can Do To Prepare For INSPIR Register for INSPIR training –go to www.bumc.bu.edu/irb Register for INSPIR training –go to www.bumc.bu.edu/irb www.bumc.bu.edu/irb Make sure everyone can log-on 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 Make sure all the studies that you currently have are listed under the correct PI – email Roz@bu.edu for a listRoz@bu.edu Close out all studies that have been completed BEFORE March 8th Close out all studies that have been completed BEFORE March 8th Contact study sponsors for electronic versions of the sponsor’s protocol Contact study sponsors for electronic versions of the sponsor’s protocol Respond to all PENDING protocols (deferrals and conditional approvals) immediately Respond to all PENDING protocols (deferrals and conditional approvals) immediately
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