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  1. Internal DSM:
    1. Washington University is the primary center (the coordinating center)
    2. We are the secondary center but DSM reports are not available from the coordinating center. Instructions on how to complete this submission can be found here: Internal DSM Completion Page

  2. Internal DSMB:
    1. Washington University is the primary center, it is a therapeutic or treatment trial, and there is one of the following:
      1. Target accrual is >300
      2. Double blinded study
      3. The trial is multicenter
      4. The trials is phase III
      5. The study is "high risk" as determined by PRMC
    2. Instructions on how to complete this type of submission can be found here: Internal DSMB Completion Page

  3. External DSM:
    1. Washington University is the secondary site and the primary site is providing semi-annual DSM reports
    2. Instructions on how to complete this type of submission can be found here: External DSM Completion Page

 


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When is my DSM Report Due? Your DSM due date is based off the study's first open to accrual date.

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  1. Serving on a DSM committee (when not listed on a study):
    1. All DSM committees must include a statistician not associated with the study.
    2. All documents required for the DSM submission and any additional documentation requested by the DSMB should be sent to the DSMB members at least a week prior to the meeting date so they have time to review the documentation.
    3. The DSMB members will review the study and make comments, recommendations as needed as well as an overall decision to continue or suspend the study.

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