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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

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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 ?

Integrated

Network

for

Subject

Protection

In

Research


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

  • 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

  • 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

  • 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

  • Login issues and technical issues will NOT be managed by the IRB office

  • Contact the IT INSPIR Team at BRAAN@bu.edu

  • Helpful advice on website under “Help!”

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


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?

  • 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.)

  • 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


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

  • 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

  • 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

  • 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

  • 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

  • March 15, 2004

  • First day protocols can be submitted electronically

    • New protocols

    • Progress Reports (Continuing Reviews)

    • Amendments


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

  • 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 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 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

  • 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

  • March 8 deadline doesnot 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 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


Go To Demo


  • Login