Data Safety Monitoring Plans (DSMP) Guidance

Version Date: August 3, 2011

Guidance on developing a data safety monitoring plan

Federal regulations require that IRBs determine whether data and safety monitoring is necessary and, if so, whether the research protocol makes adequate provision for monitoring the data collected to ensure the safety of participants.

The HS-IRBs require that all studies involving more that minimal risk to subjects have a data and safety monitoring plan.  In some cases, a formal data and safety monitoring board or committee may also be required.

Data Safety Monitoring Plans (DSMPs) vary depending on the nature, size, and complexity of the protocol; expected risks of the research; and population being studied.  If the study involves a small number of participants, is conducted at only one site, and/or the range of possible study events having an important impact on risks and benefits to participants is narrow, the principal investigator (PI) or a group of investigators could perform the monitoring functions. However, if a study is larger, more complex, and/or higher risk, a monitor/monitoring group or Data and Safety Monitoring Board (DSMB) may be required.

When developing a data and safety monitoring plan, investigators should address the following:

What are the key elements of a DSMP?

A DSMP should describe the following:

When is a Data and Safety Monitoring Board or Committee necessary?

In general, a DSMB may be the most appropriate way to monitor data and safety for studies that involve:

More information can be found at the following links:

NIH Policy requires data and safety monitoring for all NIH funded clinical trials. The divisions within the Institute have each established policies, procedures, guidelines etc. to implement and comply with the general NIH policy. [See guidance for Data Monitoring Plans and Data Monitoring Committees
Sponsors of FDA-regulated research are responsible for safety reporting to the IRB, to the study sponsors and to the FDA (particularly in the case of investigator-initiated INDs or IDEs. These guidelines incorporate Sponsor-directed safety planning. [See guidance Data Monitoring Committees