Home Forums General Discussion Forum Filing DSMB Reports and IRB Committee Member’s List?

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    • #2834
      Maria Salmon

      Can someone please advise me if I am filing the following documents appropriately?

      01-03.02: IRB Committee Member’s List
      01.03.03: DSMB Reports.

      Thank you so much!

    • #2835
      Karen Williams

      IRB or IEC Trial Approval 04.01.03 IRB or IEC Composition IRB or IEC Composition 04.01.03 IRB or IEC Composition X X Version Version date Documentation that the IRB/IEC consists of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial.

      Trial Committee 01.03.03 Committee Output “DSMB Output
      DMC Output
      Data Adjudication Output
      Steering Committee Output
      Dose Escalation Output
      Device Output
      Committee Output: Other” 01.03.03 Committee Output X Version Version date To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, to include minutes, reports, notifications, recommendations from a Trial Committee. Can be applicable to interim and final analyses.
      This is our filing sections according to our reference model filings

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