...
- Internal DSM:
- Washington University is the primary center (the coordinating center)
- 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
- Internal DSMB:
- Washington University is the primary center, it is a therapeutic or treatment trial, and there is one of the following:
- Target accrual is >300
- Double blinded study
- The trial is multicenter
- The trials is phase III
- The study is "high risk" as determined by PRMC
Instructions on how to complete this type of submission can be found here: Internal DSMB Completion Page
- Washington University is the primary center, it is a therapeutic or treatment trial, and there is one of the following:
- External DSM:
- Washington University is the secondary site and the primary site is providing semi-annual DSM reports
- Instructions on how to complete this type of submission can be found here: External DSM Completion Page
- Washington University is the secondary site and the primary site is providing semi-annual DSM reports
...
When is my DSM Report Due? Your DSM due date is based off the study's first open to accrual date.
...
- Serving on a DSM committee (when not listed on a study):
- All DSM committees must include a statistician not associated with the study.
- 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.
- 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.
- All DSM committees must include a statistician not associated with the study.
...