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  • 1.  Administrative letter vs protocol amendment

    This message was posted by a user wishing to remain anonymous
    Posted 01-Apr-2024 09:07
    This message was posted by a user wishing to remain anonymous

    When is it to use an administrative letter for change(s) in the study vs when a protocol amendment is required for FDA ? Any resources, guidelines, regulations on when to use administrative letter are much appreciated. 



  • 2.  RE: Administrative letter vs protocol amendment

    Posted 02-Apr-2024 03:29

    Anon,

    Assuming you are talking about medical devices - notification depends if you have an Investigational Device Exemption (IDE) in place or a non-significant risk device which is exempt; guidance can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-or-modifications-during-conduct-clinical-investigation-final-guidance-industry-and-cdrh.  Keep in mind the Institutional Review Board (IRB) or central IRB also may have their own criteria for notification or changes to a study; you should check with them to confirm their criteria (applicable to Significant Risk devices with an IDE and Non-Significant Risk devices).  I am sure there is information concerning drug products as well.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 3.  RE: Administrative letter vs protocol amendment

    Posted 02-Apr-2024 07:21

    I am not aware of specific guidelines or regulations that clearly differentiate an amendment versus administrative letter. Keeping in mind that the protocol should be designed in such a way as to minimize unnecessary complexity and to mitigate or eliminate important risks to the rights, safety, and wellbeing of trial participants and the reliability of data, the protocol should be amended whenever a change affects those aspects. An administrative letter should be used only when the text of the protocol requires an administrative change, such as correcting typos or clarifying the intent or process of aspects of the protocol. See for example EU guidances on substantial versus non-substantial amendments.



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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    Original Message


  • 4.  RE: Administrative letter vs protocol amendment

    Posted 02-Apr-2024 09:23

    For drugs please refer to FDA IND Application Reporting: Protocol Amendments  Sponsors are expected to submit protocol amendments for new protocols or changes to existing protocols before implementation of the respective changes if there are safety concerns with the proposed  change. New studies may begin when the sponsor has submitted the change to FDA for its review and the new protocol or changes to the existing protocol have been approved by the Institutional Review Board (IRB) with the responsibility for review and approval of the studies. If the IND application sponsor desires FDA to comment on a submission, they should submit a request for such comment and the specific questions that FDA's response should address and follow-up with the project manager to obtain informal feedback. 



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    Juliane Carvalho RAC, MSc
    Lead Regulatory Health Project Manager at CBER - OTP
    US Food and Drug Administration
    United States
    **My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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    Original Message


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