To fulfill its mandate, the IRB must ensure that the study protocol contains adequate provisions for data and safety monitoring. A data and safety monitoring plan must be incorporated into each research protocol submitted to the IRB. The plan may consist of a few simple sentences or be quite complex, depending on the nature of the research. The following links provide access to the Yale Cancer Center”s Data and Safety Monitoring Plan and the Yale University School of Medicine Data and Safety Monitoring Plan Policy and Template. The latter document provides a template to assist investigators in developing a comprehensive data and safety monitoring plan (for clinical trials).
As part of the data and safety monitoring function, investigators observe subjects for evidence of adverse events, collect experimental data, and review the accumulated data for evidence of serious and nonserious anticipated and unanticipated adverse events. Investigators must inform IRBs of any significant deviations from their approved protocols, and must promptly report all unanticipated and serious adverse events immediately (or as defined in their protocols). Nons erious and anticipated adverse events are reported annually during the renewal of approval of the protocol.
When investigators are tasked with data and safety monitoring, efficacy monitoring is generally not conducted during the study but is determined at the conclusion of the study. However, during the annual renewal of approval of the protocol, investigators are asked to demonstrate that the experiment is likely to be completed and, depending on the type of protocol, to reach a conclusion regarding the intervention’s efficacy (e.g., the likelihood that it will generate generalizable knowledge). Studies that are unlikely to recruit sufficient numbers of subjects, retain subjects, or statistically support a conclusion about the efficacy of the procedure or intervention are discontinued. It is considered unethical to continue enrolling subjects and exposing them to study-associated risks when the study will not eventually generate generalizable knowledge.
In some large, multisite studies it is impossible for any single investigator to provide the data and safety monitoring for the protocol. In these situations, depending on the nature of the study, the responsibility for data monitoring may be delegated to a group employed by the study sponsor, or to an independent DSMC. In addition to monitoring risk data (such as adverse events), a DSMC will often monitor efficacy data, and will occasionally monitor data acquisition to ensure the integrity of the data generated in the study. The monitoring functions of DSMCs are described later in this module.
No matter what type of monitoring is used, a detailed plan for data and safety monitoring must be submitted to the IRB at the time of initial protocol review. The IRB must also receive interim reports from the individual or group responsible for data and safety monitoring throughout the protocol. It is always the responsibility of the investigator to identify and report adverse events occurring in subjects directly under his/her supervision.
Audio Extra
Comments on the need for DSMPs and DSMBs(2:25), by Sandra Alfano, Chair, Human Investigation Cmte.