Where to File Risk Based Monitoring Assessment Checklist

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    • #3741
      Janna Gonzalez
      Participant

      HI All,

      Where do I file RBM Assessment Checklist.
      I was thinking 05.04.03.
      Please Advise.
      thanks,
      Janna

    • #3747
      Angela McCullagh
      Participant

      Are you talking about an assessment checklist that is completed at each individual site in order to rate them against identified risks and determine monitoring approach at that specific site; or a general checklist that is utilised to identify overall risks in order to determine the monitoring approach across the study? Or neither of these options!?

    • #3748
      Janna Gonzalez
      Participant

      Hi Angela,

      It is generated per site to assess their individual risk. Level of risk can vary from one site to the next.
      Thank you,
      Janna

    • #3763
      Richard Golden
      Participant

      If this assessment is taking place AFTER a site has been selected, then 5.4.5 seems appropriate.

      If this assessment is taking place BEFORE a site has been selected, then 5.1.3 seems appropriate.

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