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The present lecture provides information in regard to the process of data safety monitoring and the correct organization of a data safety monitoring board. As stated in the materials, safety boards oversee a number of factors during clinical trials. First, they ensure that the participants are under an acceptable modicum of harm, then that the trial process does not need to be terminated early. Additionally, the board monitors the procedures of clinical trials, their use of control groups, different substances and the relevant documentation. The DSMB has the ability to influence the flow of the trial, either modifying established protocols or fully stopping the process altogether. None of the safety board members must be financially or personally invested in the outcome of the study to guarantee the legitimacy of safety measures. The above statements generally apply to all DSMBs, but organizations and different regions have their processes of safety monitoring, complete with their specific rules and regulations. For a DSMB to be present, it is first necessary to establish which trials warrant the inclusion of DSMB. For Boston, this criteria includes all interventional clinical research involving more than minimal risk to their subjects. The Boston monitoring plans must include the types of data collected, people that will collect them, estimated time frames, frequency of operation and definitions for altering and stopping a study (DSMP in human subjects research partners healthcare). All of the above are specific requirements of the Massachusetts General Hospital. Additionally, it is allowed for the monitoring process to be conducted by different types of organizations. A singular principal investigator is allowed, as well as an organized monitoring group.
Reference
DSMP in human subjects research partners healthcare. Partners Healthcare. (n.d.). Web.
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