May 2006

Research personnel may be unfamiliar with the concept of a Data Safety Monitoring Plan and the need for a Data Safety Monitoring Committee or Board. Consideration of such a plan is part of the federal regulations … in that "when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects&quot. [21CFR 56.111 & 45 CFR 46.111]

What is a Data Safety Monitoring Plan?

A Data Safety Monitoring Plan (DSMP) provides a formal process of monitoring the data collected to ensure the safety of subjects. A DSMP should assign the responsibility for data and safety monitoring to the Principal Investigator, Sponsor/Committee, or a Data Safety Monitoring Board (DSMB). If the responsibility for data monitoring is the Sponsor/Committee or Board, the plan should explain the number of individuals responsible for this task and their qualifications for functioning in this capacity.

Additionally, a DSMP should include frequency of data analysis. For example, will the data be analyzed by time (every 6 months), by participant (after every 10 participants), or by event (after a fatality)? The plan should include stopping rules regarding the potential outcomes of the study that could have an impact on the safety or welfare or the study participants. Finally, the DSMP should describe how findings on data safety monitoring activities will be communicated to outside entities (e.g., Institutional Review Boards)

When do I need a Data Safety Monitoring Committee or Board?

For many studies, a group of experts would be necessary in order to provide meaningful evaluation of study data. These individuals may either be comprised as a Committee (Sponsor designated employees or employees of an institution) or a Board (group of experts in the field independent of the study Sponsor). These groups evaluate the study for integrity of the data as well as the risk/benefit profile for current and future participants. Data Safety Monitoring Boards are usually reserved for studies in which there are major risks to research participants. Greater than minimal risk research can be monitored and evaluated by a Committee and high risk research monitored by a Board.

In conclusion, the research study should make adequate provisions for data and safety monitoring sufficient to protect the rights and welfare of research participants. The research study should describe the basic parameters of the data safety monitoring process. Currently, the application for the Human Subjects Protection Program includes a section that asks for information pertaining to data safety monitoring. The response to questions in that section should be adequate in order to fully describe the protection of research participants.

*Amdur, R. (2006). Provisions for Data Monitoring. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 160-165). Sudbury, MA: Jones and Bartlett.