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Introduction to INSPIR. OCR Seminar Series January 21, 2004 Mary Banks, RN Administrator, Office of the IRB. “The Future Is Now” Yogi Berra. What is INSPIR ?. I ntegrated N etwork for S ubject P rotection I n R esearch. INSPIR Background.

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introduction to inspir
Introduction to INSPIR

OCR Seminar Series

January 21, 2004

Mary Banks, RN

Administrator, Office of the IRB

what is inspir
What is INSPIR ?

Integrated

Network

for

Subject

Protection

In

Research

inspir background
INSPIR Background
  • Developed as BRAIN at Baylor School of Medicine
  • Currently used at Baylor and University of Maryland (BRAAN)
  • Result of IRB Improvement Grant (NIH)
  • Customized to fit Boston University requirements
  • Will be used at BUMC and Charles River Campus
  • Used by BUMC IRB and IACUC
system requirements
System Requirements
  • January Issue of CR Times (www.bu.edu/crtimes)- link
  • Connecting to INSPIR
  • Browser
    • Macintosh, Netscape version 7
    • Safari for Mac
    • PC- Internet Explorer 6.0 or higher
  • Cookies must be enabled
  • Pop-up Blockers must be disabled

www.bumc.bu.edu/Departments/PageMain.asp?Page=8725&DepartmentID=368

useful tip
Useful Tip
  • 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
access to inspir
Access to INSPIR
  • Website “Getting Access”
  • Presence in BU’s electronic directory
  • BU Login Name, BUID Number, and Kerberos password
  • If you don’t have a presence in BU’s directory (BMC, VA) instructions available
  • Do this now- don’t wait

www.bumc.bu.edu/Departments/PageMain.asp?Page=8636&DepartmentID=368

difficulties logging into inspir
Difficulties Logging Into INSPIR
  • Login issues and technical issues will NOT be managed by the IRB office
  • Contact the IT INSPIR Team at [email protected]
  • Helpful advice on website under “Help!”

www.bumc.bu.edu/Departments/PageMain.asp?Page=8094&DepartmentID=368

what does inspir do
What Does INSPIR Do?
  • 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
  • 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)
  • Automatically generates continuing review reminders
why be inspired
Why Be INSPIRed?
  • 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
why be inspired cont
Why Be INSPIRed? (cont.)
  • Investigators can track the progress of own protocols
  • Multiple copies of documents (approval letters, consent forms, etc.) with version control can be printed
  • Applications are automatically routed for required signatures
  • Continuing Review process is much easier because amendments, SAEs, etc. are cumulatively tracked
  • Investigators can access INSPIR from any internet connected computer
slide13

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

2/23 - 3/15

Train the Investigators

important dates for investigators and research staff at bumc
Important Dates for Investigators and Research Staff at BUMC
  • February 23 - March 15

Investigator training

  • March 8

IRB Office stops accepting paper submissions

  • March 8 - 15

IRB Office closed

  • March 15

Go Live Date

investigator training
Investigator Training
  • Feb. 23 - Mar.15
  • Training will include
    • Online training
    • Investigator Manual
    • Large group classes
    • Small group classes
  • Schedule of classes will be posted
  • Practice site will be available for investigators to use
irb office stops accepting paper
IRB Office Stops Accepting Paper
  • March 8, 2004
  • All paper Progress Reports must be submitted by this date
  • Can submit Progress Reports for March, April and May
  • Last date to accept new Research Applications in paper
  • Last date to accept amendments in paper
irb office closed
IRB OFFICE CLOSED
  • March 8-15
  • No paper or electronic submissions accepted during this week
  • Investigator training will be ongoing during the week
  • IRB office staff will be available for training and to answer questions
go live
GO LIVE
  • March 15, 2004
  • First day protocols can be submitted electronically
    • New protocols
    • Progress Reports (Continuing Reviews)
    • Amendments
new irb applications
New IRB Applications
  • Full Board, Expedited and Exempt
  • Submit on paper by March 8 OR
  • Must hold and submit on or after March 15 electronically
  • Investigators can work on drafts prior to March 15
continuing review
Continuing Review
  • Progress Reports must be submitted by March 8 on paper OR
  • Must be held until March 15 for submission electronically
  • Investigators may submit on paper for March, April, May only
  • Studies that expire after May 31, 2004 – Progress Reports must be submitted electronically
continuing review1
Continuing Review
  • 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
continuing review2
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
  • Progress Reports must still be submitted at least 5 weeks prior to expiration
amendments
Amendments
  • 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)
serious adverse events
Serious Adverse Events
  • 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)
  • More information on SAEs will be coming - the IRB is modifying the policy on submitting SAEs to the IRB
demonstration of inspir
Demonstration of INSPIR
  • Demonstration site (practice site) will be available soon for use by investigators
  • Final modifications being made to the system
  • We will provide investigators paper copies of screen shots
  • We will provide an electronic Investigator’s manual
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