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Welcome To INSPIR Training

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Title: Slide 1 Author: mbanks Last modified by: mbanks Created Date: 2/12/2004 11:20:38 PM Document presentation format: On-screen Show Company: Information Technology – PowerPoint PPT presentation

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Title: Welcome To INSPIR Training


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
Jan
Feb
Mar
April
May
Mar. 8 IRB office Stops Accepting Paper
Mar. 15 GO LIVE
3/8 - 3/15 IRB office CLOSED
2/23 - 3/15 Train the Investigators
2/18 INSPIR Training
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 gt90
    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 lt90 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
Go to https//braan.bumc.bu.edu/brainlogin.asp
  • Use your BU user name as your log-in name
  • Use your BU/ Kerberos password as your password
  • Click log-in

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

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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

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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

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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

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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

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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

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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)

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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

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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_at_bu.edu for a list
  • Close out all studies that have been completed
    BEFORE March 8th
  • Contact study sponsors for electronic versions of
    the sponsors protocol
  • Respond to all PENDING protocols (deferrals and
    conditional approvals) immediately
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