DSM Report Instructions

Data Safety Monitoring Reports, or DSMs, are required for each institutional clinical trial. Your DSM report fulfills the NCI requirement for clinical trials to have a data safety monitoring plan. The report also provides information for the NCI Clinical Trials Reporting Program (CTRP) and FDA submissions.

Determining the Report Type Required:There are 3 different types of DSM submissions. The logic below will help you determine which DSM submission is correct for your study Internal DSM):

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

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

 Your DSM is due every 6 months from the first open to accrual date.

For example: Your study opened to accrual on 7/6/18; your DSMs will be due on 1/6 and 7/6 of every year.

Regardless of DSM type, the first DSM is due 6 months after the study has opened to accrual, if five patients are enrolled. Otherwise the first DSM is due 1 year after the study has opened to accrual. From then on, DSMs are due semi-annually until the last patient has been off treatment for 6 months. DSMs should be submitted to the QASM DSM coordinator at QASMC@wudosis.wustl.edu. The DSM coordinator will perform a pre-review of the report to check for accuracy. You may receive questions or requests for additional information before the report is scheduled for review by the Quality Assurance Safety Monitoring Committee (QASMC).

Tracking your Submission in OnCore:

1. DSM reports can be tracked through the vertical "Reviews" tab in the PC Console
   
   1. From the Home Screen navigate to the Protocols menu > PC Console > Reviews > QASMC
      
   2. Identify the review submission you are tracking
   3. Click "Details"
   4. Check the Summary field for the Due Date
   5. 
   6. Communications Block
      1. Upcoming DSM Notification - corresponds to the date the study team was notified about their upcoming DSM report due date
         
      2. Submission Date - corresponds to the date the study team submitted the DSM report for review
      3. Pre-Review - corresponds to the date the DSM coordinator reviewed your report
      4. Action Notice - corresponds to the date your DSM approval (Approval) or contingency letter (Contingent) was sent

The Statistician’s Role in the DSM Process:

1. Review of the electronic report (when listed on a study):
   
   1. All Internal DSM and Internal DSMB reports require the protocol’s statistician to review the report.

   2. Specially, the protocol’s statistician should focus on the following:

      1. Reviewing the number of evaluable patients and the number of patients that have met an objective

      2. Reviewing stopping rules for toxicity and feasibility
      3. Providing an interim analysis when applicable/prompted by the study team
      4. Confirming the study design is being followed according to the statistical plan
   3. All documents required for the DSM submission should be sent to the statistician at least a week prior to the DSM due date to allow the statistician enough time to review the report.

1. Attendance at DSMB meetings (when listed on a study):
   
   1. It is not required, but recommended that the study statistician attend DSMB meetings to provide updates on results to date and to answer any questions that arise regarding the statistical plan or analysis.

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.