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  • Ask the Expert: Postapproval Monitoring

    May 3, 2021 9:25 AM
    Posted in: IACUC Channel

    Do you have lingering questions about your IACUC's postapproval monitoring (PAM) systems? Reply to this post with your questions by May 14 and Brittany Backus, PhD, IACUC Director and Post Approval Monitor at Texas Tech University, will respond by ...

  • Process for informed participants of their drug/placebo ...

    May 7, 2021 11:38 AM
    Posted in: IRB Forum

    What is your institutions process for informing participants of their drug or placebo designation after a clinical trial is complete? Are all participants informed automatically or are they required to request this information from the investigator or ...

  • RE: Exempt determination for IDE

    May 7, 2021 10:44 AM
    Posted in: IRB Forum

    While the study sponsor (or sponsor-investigator) is ultimately responsible for making the determination, past FDA Warning Letters suggest that the IRB is expected to confirm the assessment. In the infamous Coast IRB case, the IRB was cited for, ...

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