Data and Safety Monitoring Plans

All clinical trials supported by the NC TraCS Institute are required to have a Data and Safety Monitoring Plan (DSMP).

The DSMP may vary from simple to more detailed, depending on the level of risk imposed on the research subjects in the course of the research protocol. The DSMP should address study risk, how risk will be minimized, safety tests/measures in place to protect subjects, a process for characterizing and reporting of adverse events, and a description of how study investigators will oversee the safety of research subjects.

In many cases, written documentation of a Data and Safety Monitoring Plan (DSMP) is needed as part of an application for funding (NIH, K Awards). The DSMP is included in the human subject’s protection section of the grant.

We offer pre-review of grant submissions to determine the adequacy of the human subject’s protection section. To arrange a review of your grant submission, contact Marie Rape.

Guidance documents to help in developing a Data and Safety Monitoring Plan: