DSMB Charter Template

The table below summarizes the Data and Safety Monitoring Board (DSMB) Charter document.

Download the DSMB Charter Template.

Tool: DSMB Charter Template
Purpose: Suggested template to be used as a starting point for preparing a DSMB Charter
Audience/User: DSMB Chair or designee responsible for preparation of DSMB Charter
Details: This template includes a proposed structure for a DSMB Charter as well as draft language and other guidance.
Best Practice Recommendations:
  • Review this template and customize to the specific needs and requirements of the DSMB. Sample text may be updated as needed.
  • In the template, the instructions and explanatory text are indicated by {blue italics} Instructional text will also be enclosed in braces to signify this text for screen-readers used by the visually impaired.
  • Text enclosed with <> is a placeholder for a specific detail (e.g., <protocol title>); replace as appropriate.
  • Delete template-specific instructional text as well as this Tool Summary Sheet during the Charter development process.
  • Leave the template version information in the lower left hand corner of the document.
  • It is easiest and cleanest to use the styles that are embedded in the document, rather than to create your own.
  • Ensure that all placeholder and example text is replaced with the study specific information.
  • A DSMB may be constituted for a single protocol or for a clinical area. Update this document to reflect this distinction.
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