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  • 1.  Clinical Quality Assurance Procedures - Medical Device Trials

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2019 12:35
    This message was posted by a user wishing to remain anonymous

    Hi everyone, 

    According to ISO 14155, the sponsor is responsible for establishing clinical quality assurance procedures. Can somebody provide any guidance on what elements should be included in this clinical quality assurance procedure? 

    Thanks!


  • 2.  RE: Clinical Quality Assurance Procedures - Medical Device Trials

    Posted 17-Apr-2019 09:31
    Hello,

    Have you looked at ICH E6 (R2) section 5?

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    Gretchen Upton RAC
    RA/QA
    TX
    United States
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    Original Message


  • 3.  RE: Clinical Quality Assurance Procedures - Medical Device Trials

    Posted 17-Apr-2019 11:32
    Hello,

    Unfortunately in the medical device world there is not too much additional guidance centred around ISO 14155.  As Gretchen mentioned go to ICH E6 as has lots of helpful information for putting together clinical trials - albiet this is for pharmaceutical - there are concepts that can be used such as quality assurance procedures.  Also FDA has some guidance documents surrounding clinical trials that while does not address quality assurance procedures specifically, contains some helpful information.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Clinical Quality Assurance Procedures - Medical Device Trials

    Posted 17-Apr-2019 12:30
    This does not mean one procedure, but typically includes CQA roles and responsibilities, vendor ID, selection, and management, training, internal audits, external audits (for CROs/service providers, investigator site audits, phase 1 unit audits, CSR audits), internal oversight procedures, depending on the internal activities that go on in your company, training, Quality Agreements, protocol deviations, review and approval of clinical documents, request for shipment of clinical supplies, etc.

    There are numerous activities that must have procedures depending on whether your company is virtual or if you do these activities in house and that will impact sops in Regulatory (listing on clintrials.gov, and release of initial drug shipments to clinical sites) and clinical (review and approval of protocols and other clinical documents that should have CQA involvement, etc.) I would need more information on how your company operates to give you a thorough answer.  You are welcome to contact me directly if you need more information dmurgai@gxpqsllc.com .

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    Dalal Murgai
    Chief Operating Officer
    GXP Quality Systems, LLC.
    The Woodlands TX
    United States
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    Original Message


  • 5.  RE: Clinical Quality Assurance Procedures - Medical Device Trials

    Posted 17-Apr-2019 14:47
    Straight forward - we are talking about SOPs and document control.  If you work in industry, we place the clinical department work under the quality system of the company. Hence, documents such as CIP, IB and other essential documents will be released following the document release procedures of the company.  All critical elements of the daily work will be covered under written SOPs.  Forms shall also become controlled documents and all records and documents be filed under a defined filing system.
    If you work in a CRO, same thing - have SOPs and an organized filing system in place. 
    If you work as a freelancer, I would say you normally do not need to have SOPs in place, as normally you would need to work as per the Sponsor's SOPs.
    Hope this helps. Happy to clarify further if needed.

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    Tami Abudi
    Matan
    Israel
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    Original Message


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