Western IRB (WIRB) Update August 6, 2004

1
Western IRB (WIRB) UpdateAugust 6, 2004

• Leslie Cooper
• Assistant Director/WIRB Liaison
• Office of the IRB
• University of Alabama at Birmingham

2
WIRB Online Submissions

• Use WIRB Online Submissions for following
  submissions
• Changes to Protocol
• Changes in Research to Subject Consent Forms
• Address Changes
• Advertisements for previously approved protocols

3
Online Submission Tutorial

• Tutorial is available on WIRBs website,
  www.wirb.com in the Online Submissions section
• Complete Submission Form
• Additional Documentation
• Attach documents that you are submitting (consent
  form, protocol amendment, investigator brochures,
  etc.)
• Will require electronic files
• Specify Transmission Method
• Indicate how approvals should be sent to contacts

4
Online Submission Tutorial

• Confirmation
• Page will display all the data on the previous
  data entry pages
• Review everything before you hit Submit button!
• Tracking Number Assignment
• You will receive a tracking number via e-mail
  notification from Client Services.

5
Online Submission Pointers

• Your documents have to be in electronic format in
  order to attach to the online submission.
• Accepted File Types
• Microsoft Word - .doc
• Text - .txt, .rft
• Microsoft Excel - .xls
• Microsoft Powerpoint - .ppt
• Adobe Acrobat - .pdf
• Image/Scan Formats - .jpg, .gif, .tif, .bmp

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Online Submission Pointers

• If you receive a hard copy document and want to
  submit online, your options are
• Scan document yourself
• Have printing company scan document
• Please note you might have to get approval from
  sponsor due to confidentiality of protocols and
  investigators brochures.
• Consent Form should always be in a Microsoft Word
  document file

7
Adverse Events

• IND Safety Reports, MedWatch Forms, or other
  sponsor-generated safety reports
• Submit with cover letter that contains PIs full
  name, Protocol number, and list of Manufacturers
  Control Numbers (MCN) and/or report dates for
  each form submitted.
• Serious AND Unanticipated AND Related should be
  reported within 10 working days.
• Other adverse events that do not fall into
  above category should be entered on the Adverse
  Event Log and submitted at Continuing Review.

8
WIRB Billing

• Initial Review Submission Form
• 47 indicates the need for verification from
  person listed as billing contact if other than PI
• This HAS to be included in the submission or it
  cant be sent to WIRB.

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WIRB Billing

• If the sponsor wants WIRB to bill the PI
• Issue of 19 overhead
• Losing money
• Fee Schedule has been created to cover the costs
  (UAB IRB fee WIRB fee combined and 19 overhead
  added to fees)
• Administration is looking into options for
  processing WIRB invoices

10
Questions Discussion

• Ms. Leslie Cooper
• lcooper_at_uab.edu
• Ph 934-3789
• Fx 934-1301