Regulatory Open Forum

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  • 1.  Regional IRB Recommendations

    Posted 06-Mar-2017 10:56
    I have a client in need of regional IRB for their small, likely NSR clinical study.  In this case, the academic institution's IRB appears to not understand what NSR means how to review them.  They referred the client to FDA for information--not an SR decision, but an IDK answer!
    I haven't worked with a regional IRB for several years.  Can anyone make some recommendations?  This particular study will be in CA.

    Thank you in advance! 

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    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com
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  • 2.  RE: Regional IRB Recommendations

    Posted 06-Mar-2017 11:17
    Karen,

    You may refer your client to a commercial IRB(s) depending upon your device type. You can find easily on Google. 

    Also Univ IRB can be educated for low cost.  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 3.  RE: Regional IRB Recommendations

    Posted 07-Mar-2017 12:28
    Since central IRBs do everything electronically now, there isn't a benefit for them to be local or regional. I would pick one that gives you great service. We have been using Sterling IRB for years and have never had anything but excellent customer service.

    To eliminate doubt for the IRB, I recommend you submit the study risk determination request to FDA. We've done 7 SRDs now and all have had a response in 28 days or less. Whether SR or NSR, the FDA determination letter is then submitted as an attachment to the IRB submission.

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    Kevin Hawkins, RAC
    Director, Quality & Regulatory Affairs
    Wilsonville OR
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    Original Message


  • 4.  RE: Regional IRB Recommendations

    Posted 08-Mar-2017 10:31
    Hi Karen,

    I know a lot of companies, including one of my clients, use Western IRB (WIRB) and have had a good experience.  The reviews are very quick.

    Julie

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    Julie Broderick RAC
    Principal/Consultant
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States
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    Original Message


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