DSMB Charter Template

DSMB Charter Template Summary Sheet

Download the DSMB Charter Template. Below is a summary of the document.

 

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.