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Human Ethics - Approval letters

  • 1.  Human Ethics - Approval letters

    Posted 06-27-2022 08:29
    Hello,
    We have started implementation at Queen's University in Canada and I wonder how current sites are navigating the following GCP requirement to specify the 'documents reviewed/version dates'? In our current system we are able to generate tables to include this information on approval letters. This is essential for Sponsor oversite at our institution. Is this just manages at in the system at your site? Any suggestions are welcome!

    "3.1.2 The IRB/IEC should obtain the following documents:
    trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities.
    The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following..."

    Thanks!
    Jen

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    Jennifer Couture
    Manager, Research Ethics Compliance
    Queen's University
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