Data and Safety Monitoring Plan (DSMP) Guidelines

These guidelines were developed to assist you in preparing a DSMP, and which can be incorporated into the Human Subjects section of your protocol in a narrative form.

There are several steps to a DSMP plan, which include the following:
Step 1 – Brief Description of the Study
Step 2 – Risk Assessment
Step 3 – Plan for Monitoring and Safety Review
Step 4 – Plan for Data Management
Step 5 – Plan for Adverse Event Reporting
Step 6 – Protection of Human Research Participants-Computer Based Training


Step 1 – Brief Description of the Study: May use protocol abstract

Step 2 – Risk Assessment:

Estimate risk level (low, medium, high) and briefly discuss risk consideration relevant to your protocol. For help in determining your protocols risk level click here.

Step 3 – Plan for Monitoring and Safety Review:

For additional information on Data Safety Monitoring Boards


Step 4 – Plan for Data Management:

Step 5 – Plan for Adverse Event Reporting:

Step 6 – Protection of Human Research Participants-Computer Based Training: