A new institution-wide DSMP for human subject research conducted at BIDMC (BIDMC policy no. RS-13) was reviewed and approved at the January 9, 2007 meeting of the Research Advisory Committee, and the February 5, 2007 meeting of the Operations Council.  Effective March 12, 2007 all BIDMC investigators are required to address the data safety monitoring (“DSM”) needs of the studies they propose.  This policy (RS-13) can be found in the BIDMC Policy Manual under Organizational PPDGs under the general portal.  Please take time to review this policy carefully.

The process for assessing Data and Safety Monitoring needs of an individual study are as follows:

• Pursuant to the DSM policy, investigators must make the first assessment of risk for the study proposed and describe the measures they will take to adhere to the policy and effectively monitor safety.  To facilitate this assessment, the CCI application has added PART P – DATA SAFETY MONITORING PLAN which all investigators must complete and present for scientific review as well as CCI review.  For minimal risk studies, the investigator’s signature is required to demonstrate knowledge of the institutional requirements for data safety monitoring.  For moderate risk and high risk studies, investigator requirements range from detailing a plan for monitoring to constituting a Data Safety Monitoring Board;

• Investigators must present Part P to the Scientific Reviewer who will confirm the risk assessment and will further assess the appropriateness of the plan proposed for the study;

• Investigators must present Part P as part of their CCI application, along with the approved Scientific Review form to the CCI.  The CCI will provide final confirmation of risk level and appropriateness of the monitoring plan.