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. |