External DSM Completion

Obtaining Reports from the Primary Site:

1. Please ask the primary site for a data safety monitoring report every 6 months. It is not sufficient to provide the approval of the report alone.

2. If the site is unwilling or unable to provide a report, an Internal DSM (electronic template) should be completed for Washington University patients and submitted instead.
   
   

Documentation Required for QASM submission:

1. Provide the external report signed by the Washington University PI.

2. Provide documentation of the most recent audit/monitoring conducted.

3. If QASM does not think the external report is robust, it reserves the right to ask for additional documentation (i.e. additional toxicity, response or accrual details).