Welcome To INSPIR TrainingWelcome To INSPIR Training

• Please be sure Please be sure

to sign- into sign- in

• Please be sure you try to log Please be sure you try to log –on to INSPIR before you –on to INSPIR before you leaveleave

• Please be sure that Please be sure that

you get a handoutyou get a handout

Let Me INSPIR YouLet Me INSPIR You

INSPIR TrainingINSPIR Training

Mary Banks RNMary Banks RN

AdministratorAdministrator

BUMC Office of the IRBBUMC Office of the IRB

Jan Feb Mar April May

summer

3/8 - 3/15IRB officeCLOSED

2/23 - 3/15Train the Investigators

Mar. 8IRB office

Stops Accepting

Paper

Mar. 15GO LIVE

2004

2/18INSPIR

Training

ClarificationClarification

Paper protocolsPaper protocols

• Refer to status of all Refer to status of all current IRB studies current IRB studies

• Whether submitted by Whether submitted by paper, fax, email, etc.paper, fax, email, etc.

Electronic submissionElectronic submission

• Refer to studies in INSPIRRefer to studies in INSPIR

Migrating Data to INSPIRMigrating Data to INSPIR

• Active studies from the current IRB databaseActive 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 databasePI has to be in INSPIR database• Before March 15, 2004Before March 15, 2004• Limited information will be transferred to INSPIR Limited information will be transferred to INSPIR

electronicallyelectronically• Study will receive a new INSPIR study number (H-Study will receive a new INSPIR study number (H-

XXXXX)XXXXX)• Old IRB number will be included in the title field Old IRB number will be included in the title field

(searchable)(searchable)• All other fields in the database must be populated All other fields in the database must be populated

by the investigatorsby the investigators

IRB Office Stops Accepting IRB Office Stops Accepting PaperPaper

Monday March 8, 2004Monday March 8, 2004• All study materials (paper, fax, email) All study materials (paper, fax, email)

must be submitted must be submitted before this date before this date – except SAEs/safety reports/deviationsexcept SAEs/safety reports/deviations

• Can only submit Progress Reports for Can only submit Progress Reports for March, April and MayMarch, April and May

• Last date to accept Last date to accept newnew Research Research Applications in paperApplications in paper

• New applications submitted in paper New applications submitted in paper will have to be converted to INSPIRwill have to be converted to INSPIR

IRB OFFICE CLOSEDIRB OFFICE CLOSED

March 8-15, 2004March 8-15, 2004• No paper or electronic No paper or electronic

submissions will be submissions will be accepted during this accepted during this weekweek

• IRB Office will be IRB Office will be working on the data working on the data migration activitiesmigration activities

GO LIVEGO LIVE

March 15, 2004March 15, 2004

• Ides of MarchIdes of March• First day protocol First day protocol

materials can be materials can be submitted electronically submitted electronically using INSPIRusing INSPIR– New protocolsNew protocols– Progress Reports (Continuing Progress Reports (Continuing

Reviews)Reviews)– AmendmentsAmendments– SAEsSAEs

When Can I Access My Study In When Can I Access My Study In INSPIR?INSPIR?

All All Approved ProtocolsApproved Protocols (with no (with no pending amendments and CRs are pending amendments and CRs are up to date)up to date)

• Limited study information will be Limited study information will be migrated to INSPIR by March 15migrated to INSPIR by March 15

• Then all study documents (that were Then all study documents (that were not submitted in paper before March not submitted in paper before March 8) must be submitted electronically 8) must be submitted electronically

• SAEs can still be submitted in paper SAEs can still be submitted in paper until the study is fully converted to until the study is fully converted to INSPIRINSPIR

When Can I Access My Study In When Can I Access My Study In INSPIR?INSPIR?

All All Expired ProtocolsExpired Protocols will be closed and will be closed and cannot be migrated to INSPIR.cannot be migrated to INSPIR.

• past expiration date without CR past expiration date without CR or or • outstanding conditional approval outstanding conditional approval

/deferral >90 days) /deferral >90 days)

To prevent this from happening you must To prevent this from happening you must respond to the Expiration/ 90 day respond to the Expiration/ 90 day warning email from the IRB prior to warning email from the IRB prior to March 2, 2004March 2, 2004

When Can I Access My Study In When Can I Access My Study In INSPIR?INSPIR?

All currently All currently PENDING ProtocolsPENDING Protocols (with pending amendments or (with pending amendments or CA/deferrals <90 days)CA/deferrals <90 days)• Cannot be migrated to INSPIR until Cannot be migrated to INSPIR until

all PENDING issues are resolved IN all PENDING issues are resolved IN PAPER- will not have a presence in PAPER- will not have a presence in INSPIR until pending issues resolvedINSPIR until pending issues resolved

• After pending issues resolved these After pending issues resolved these studies will be migrated to INSPIRstudies will be migrated to INSPIR

• PI must respond to these PI must respond to these CA/deferrals before 90 days or these CA/deferrals before 90 days or these studies will be closedstudies will be closed

Components of INSPIR Components of INSPIR to be Covered Todayto be Covered Today

• Logging – onLogging – on• Roles (investigator, PI)Roles (investigator, PI)• View Protocols screenView Protocols screen• Individual protocol screensIndividual protocol screens• Set PrivilegesSet Privileges• Entering Entering newnew studies into studies into

INSPIRINSPIR• Converting Converting approved approved

studiesstudies to INSPIR to INSPIR

Check Ability to Log In to Check Ability to Log In to INSPIRINSPIR

• Use your BU user name as Use your BU user name as your log-in nameyour log-in name

• Use your BU/ Kerberos Use your BU/ Kerberos password as your passwordpassword as your password

• Click log-inClick log-in

Go to https://braan.bumc.bu.edu/brainlogin.aspGo to https://braan.bumc.bu.edu/brainlogin.asp

Problems with Logging OnProblems with Logging On

• Need a presence in Need a presence in the BU Active the BU Active Directory as BU Directory as BU employee or guestemployee or guest

• Registered for Registered for INSPIRINSPIR

• Browser settings Browser settings correctcorrect

Troubleshooting Log-on Troubleshooting Log-on ProblemsProblems

• Make sure you have Make sure you have the correct websitethe correct website

• Browser settingsBrowser settings

• Using BU user name Using BU user name and passwordand password

• Go to INSPIR page for Go to INSPIR page for help help www.bumc.bu.edu/inswww.bumc.bu.edu/inspirpir

INVESTIGATOR RoleINVESTIGATOR Role

• Applies to ALL members of the research staff Applies to ALL members of the research staff (PI, study coordinators, data managers, (PI, study coordinators, data managers, research nurses, co-investigators)research nurses, co-investigators)

• For each study a PI is identified in the For each study a PI is identified in the systemsystem

• For each study the PI determines who may For each study the PI determines who may view and /or modify the protocol (using Set view and /or modify the protocol (using Set Privileges function)Privileges function)

• Only the investigator who is named the PI on Only the investigator who is named the PI on a study has access to the SUBMIT buttona study has access to the SUBMIT button

• Will not be able to assign a study to a PI who Will not be able to assign a study to a PI who is not in the INSPIR databaseis not in the INSPIR database

SUBMIT FunctionSUBMIT Function

• Only the PI can submit new Only the PI can submit new protocols, Progress Reports (CR), protocols, Progress Reports (CR), and amendmentsand amendments

• Any investigator with read/write Any investigator with read/write privileges can submit SAEs, privileges can submit SAEs, deviations, exceptionsdeviations, exceptions

• Ability to submit is determined Ability to submit is determined by by – PI status on the studyPI status on the study– Submit privileges in the systemSubmit privileges in the system– If PI is unable to “submit” contact If PI is unable to “submit” contact

the IRB officethe IRB office

Submission ControlSubmission Control

• Using the “submit” button = PI Using the “submit” button = PI signaturesignature

• Only the PI can submit Only the PI can submit items that alter the “approved” items that alter the “approved” version of the protocolversion of the protocol

• BU policy against giving out BU policy against giving out password to anyonepassword to anyone

• IRB policy is that only the PI is IRB policy is that only the PI is allow to submit /change allow to submit /change protocolprotocol

• All other members of the All other members of the research staff should NOT research staff should NOT submitsubmit

• PI has access from any internet PI has access from any internet sitesite

View ProtocolsView Protocols

• Overview of all of your studiesOverview of all of your studies• Divided up into “piles”Divided up into “piles”• Red stars next to studies that require Red stars next to studies that require

attention (pending issues)attention (pending issues)• Can also see studies where you are co-Can also see studies where you are co-

investigator or research staff if the PI has investigator or research staff if the PI has granted read privileges to yougranted read privileges to you

• Studies will appear as Human (draft form) Studies will appear as Human (draft form) or with H-number (if submitted)or with H-number (if submitted)

• Old IRB number will be included in the Old IRB number will be included in the title-searchable fieldtitle-searchable field

• Can see when approval expires for each Can see when approval expires for each studystudy

Protocol PageProtocol Page

• From View Protocol page – From View Protocol page – click onto a protocolclick onto a protocol

• Opens up that protocol to Opens up that protocol to cover page- displays cover page- displays overall infooverall info

• Select from drop down Select from drop down “What do you want to do” “What do you want to do” menumenu

Set PrivilegesSet Privileges

• From Protocol PageFrom Protocol Page

• ““What do you want to do?” What do you want to do?” drop down drop down

• Select “set privileges”Select “set privileges”

• Can add others to read Can add others to read only or read writeonly or read write

• Also determine who will Also determine who will get email notificationsget email notifications

Entering New Studies into Entering New Studies into INSPIRINSPIR• Will have to “take human exam” Will have to “take human exam”

the first timethe first time• PI may initiate studyPI may initiate study• Coordinator can initiate study- Coordinator can initiate study-

default PI must be changeddefault PI must be changed (PI must be in INSPIR database)(PI must be in INSPIR database)• Coordinator should then grant Coordinator should then grant

privileges to himself/herself to be privileges to himself/herself to be able to access that study againable to access that study again

--read/write privileges--read/write privileges• Can copy from other protocol (if Can copy from other protocol (if

you have access)you have access)

Conversion of Approved Studies to Conversion of Approved Studies to INSPIRINSPIR

• Can do a conversion amendment at any Can do a conversion amendment at any point- must do before submitting another point- must do before submitting another amendment or a Progress Report amendment or a Progress Report

• Locate in View Protocols- initially only Locate in View Protocols- initially only the PI will have access to the protocol the PI will have access to the protocol

• Studies listed under the incorrect PI will Studies listed under the incorrect PI will be hard to locatebe hard to locate

• Will have H number (INSPIR protocol Will have H number (INSPIR protocol number)number)

• Will have only minimal fields completedWill have only minimal fields completed

Conversion of Approved Studies to Conversion of Approved Studies to INSPIRINSPIR

• Open studyOpen study

• Create amendment-select conversion to Create amendment-select conversion to INSPIRINSPIR

• Open protocol (IRB application)Open protocol (IRB application)

• Complete like a new applicationComplete like a new application

• Create consent formCreate consent form

• Submit (no signatures necessary)Submit (no signatures necessary)

• Once conversion is approved then you Once conversion is approved then you can submit additional amendments / can submit additional amendments / Progress ReportProgress Report

Convert to INSPIR-SpecialConvert to INSPIR-Special

• Interventional studies in Interventional studies in Long-term follow-up or data Long-term follow-up or data analysis phaseanalysis phase

• No ongoing interventionsNo ongoing interventions

• Not necessary to enter entire Not necessary to enter entire study into INSPIRstudy into INSPIR

• Study will become “Long-Study will become “Long-term FU of Study 2001-XXX “term FU of Study 2001-XXX “

• Directions will be posted on Directions will be posted on IRB websiteIRB website

What You Can Do What You Can Do To Prepare For INSPIRTo Prepare For INSPIR

• Register for INSPIR training –go to Register for INSPIR training –go to www.bumc.bu.edu/irbwww.bumc.bu.edu/irb

• Make sure everyone can log-onMake sure everyone can log-on• Make sure all the studies that you Make sure all the studies that you

currently have are listed under the currently have are listed under the correct PI – email correct PI – email Roz@bu.eduRoz@bu.edu for a for a listlist

• Close out all studies that have been Close out all studies that have been completed BEFORE March 8thcompleted BEFORE March 8th

• Contact study sponsors for electronic Contact study sponsors for electronic versions of the sponsor’s protocolversions of the sponsor’s protocol

• Respond to all PENDING protocols Respond to all PENDING protocols (deferrals and conditional approvals) (deferrals and conditional approvals) immediatelyimmediately