Essential Elements of a Data Safety and Monitoring Plan for Clinical Trials Funded by the NCI

This document outlines the essential elements of an adequate plan for data and safety monitoring (DSM) of clinical trials. It is intended to assist investigators and institutions in the formulation of DSM plans for all phases of cancer clinical trials, in accordance with National Institutes of Health (NIH) requirements. We suggest that institutions sponsoring a significant number of clinical trials formulate institutional DSM plans that can be broadly applied to the individual trials in their portfolio. Investigators from institutions or organizations without institutional DSM policies may also find this document useful as a guide in fashioning suitable DSM plans for their individual trials.

To get an idea of what a final DSM plan might consist of, see Data and Safety Monitoring Example Plans.