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 ?. 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

Introduction to INSPIR

OCR Seminar Series

January 21, 2004

Mary Banks, RN

Administrator, Office of the IRB


The future is now yogi berra

“The Future Is Now”Yogi Berra


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


Introduction to inspir

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 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 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

Go To Demo


  • Login