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Many of WIRB's Word-format submission forms are now retired and replaced with dynamic, PDF-based submission forms!  
 
New pdf-based smart forms are now available below for sending initial reviews, changes in research, promptly reportable information, and study closure information.
 
PPlease note the following about our smart forms:
  • The smart forms must be completed using either Adobe's free Reader or Adobe Acrobat (version 11 or newer). Use of a program other than Adobe (version 11 or newer) to view or complete the forms will result in missing questions and non-functional fields.  To download Adobe Reader for free, please visit https://get.adobe.com/reader/. (If you do not have access to Adobe's Reader or Acrobat, please contact us to obtain an alternate, Word submission form).   
  • Because these smart forms are dynamic (change based on your responses), they must be completed electronically; therefore, you cannot print them out and complete them on paper. However, at any time during their completion, you can edit, save, print, or share with your colleagues.
  • We will continue to accept the old form until October 7, 2017.
  • The forms have been adopted by WIRB, NEIRB, MLIRB, Aspire, and CGIRB.​ 
A brief orientation and tutorial on the forms' functionality is available here:  http://www.cgirb.com/wp-content/uploads/2015/12/WCG-SMART-Forms- Training-Guide.pdf.

The forms below provide WIRB with all the required IRB review information required.  Please provide a submission form with each protocol you submit for review.  
 
For questions or assistance, please see the WIRB Guide for Researchers available below, call 1-800-562-4789, or email clientservices@wirb.com.
About expanded access to investigational drugs, biologics, and devices

FDA has set up several methods to access investigational drugs, biologics, and devices. The agency has outlined those methods here Expanded Access (Compassionate Use). WIRB follows the requirements outlined by FDA; see below for details about what information we need in order to provide review for each type of situation. 


I. DRUG - Access to Investigational Drugs for Treatment Use (pre-use):
On June 2, 2016, FDA released three documents regarding expanded access: 

Submission requirements for pre-use of a drug:
  
To request a review for a single-patient expanded access, the following information must be submitted
    1. Completed FDA form 3926 Individual Patient Expanded Access Investigational New Drug Application (IND)
    2. Consent Form. For your convenience, a single patient consent form template is available from WIRB. Use it to write your own and submit to WIRB for review.
    3. Completed Initial Review Submission Form "Physician submitting for approval of a Single Patient Expanded Access" branch (if the form doesn't open when you click the link, right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and  then open the destination folder  on your computer to open the form). 
    4. Documentation of FDA IND Number, if available; if not available, indicate when the submission to FDA was done
    5. IB (or reference to existing information) or supporting literature
    6. CV for the treating physician (if a current one is not already on file with WIRB)
    7. Medical License for the treating physician (showing the expiration date) (if a current one is not already on file with WIRB)

  • If you have any questions, or if we can be of further assistance, please contact us (clientservices@wirb.com).
  • If, after submitting the requested information, the patient’s condition changes such that he/she no longer needs approval of the single patient expanded access request, please notify us at your earliest opportunity.
  • For more information on expanded access go to: http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

 



II. DEVICE - Access to Investigational Devices for Treatment Use (pre-use):

 
FDA has provided guidance on Expanded Access for Medical Devices at http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/ucm051345.htm .
The following requirements are taken from the
Compassionate Use section of that page.


Submission requirements for pre-use of a device:
  
To request a review and IRB Chair concurrence for the compassionate use of a device, the following information must be submitted:

 


III. Drug and Device Emergency Use: Post-Use Report

To report the emergency post-use of a an investigational drug, biological product, or a device with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there was not sufficient time to obtain IRB approval [21 CFR 56.102 (d)]. Use the WIRB Emergency Use Post-Use Report Form.



Reports should be submitted to an IRB (not just contact with IRB staff) within 5 working days of the use. [21 CFR 56.104(c) and 814.124 (a)]

Submission requirements for post-use of a drug or a device:
  
To request a post-use review of the emergency use of a drug or a device, provide the following information:
    1. Completed WIRB Emergency Use Post-Use Report Form
    2. Consent form (if used)
    3. Second opinion from an independent physician
    4. Any communication with the FDA - an IND if a drug or biologic; or an IDE if a device
    5. If a device with an existing IDE, authorization from the sponsor
    6. Clearance from your institution (if applicable), as specified by its policies.

You may also use the WIRB Emergency Use Post-Use Report Form to report use of a Humanitarian Use Device (HUD) at a facility without prior IRB approval
because approval could not be obtained in time to prevent serious harm or death to a patient.






Sending your submission to WIRB:
Please complete and return your request to WIRB via e-mail (clientservices@wirb.com) or via Connexus®.


 
 
 
 
 
 
 
 
 
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