A data and safety monitoring plan (DSMP) is an essential part of any clinical investigation. As outlined in National Institutes
of Health (NIH) guidelines1,2 the Code of Federal Regulations,3,4 and Good Clinical Practice (GCP) Guidelines,5 DSMPs are designed to ensure subject safety and data validity.
Despite their importance, DSMPs, in our experience, are often less well defined than other components of a research protocol,
particularly when they are designed by investigators rather than by industry sponsors. Consequently, data and safety monitoring
is frequently neglected during the study's duration.
To assist investigators in developing and implementing proper DSMPs, the Partners Human Research Quality Improvement Program
(QI Program) developed a set of guidelines, including a checklist, to ensure not only that all necessary elements of a DSMP
are included in the protocol, but that they are implemented accordingly throughout the duration of the study.
The purpose of this article is to describe and share these guidelines. They are likely to be relevant to anyone involved in
designing, implementing or reviewing clinical research protocols, including investigators, study coordinators, research administrators,
and IRB members at academic, medical, and research institutions. Background
While there is an abundance of published literature concerning Data and Safety Monitoring Boards, the basic elements of DSMPs
have gained considerably less attention. A few papers published to date emphasize the importance of developing DSMPs prior
to the initiation of a study.6-8 The complexity of the plan will vary depending on the degree of risk involved; indeed, risk assessment is the pivotal first
step in designing the DSMP.7 Once established, investigators should be prepared to modify monitoring plans based on findings by the Data and Safety Monitoring
Boards, safety monitors, and/or the investigator's monitoring of study subjects.8
Up Close: What a Good Data and Safety Monitoring Plan Looks Like
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As far back as 1979, NIH issued a policy stating, "every clinical trial should have provision for data and safety monitoring."9 In 1998, NIH published guidelines describing necessary elements for adequate data and safety monitoring for clinical trials.1 This document indicated that depending on the nature, size, and complexity of a study, various types of monitoring could
be anticipated to evaluate the data quality and safety of the subjects.
It further recognized that the principal investigator may be responsible for monitoring investigator initiated Phase I studies,
while a committee of experts (e.g., a Data Safety Monitoring Board) may be responsible for Phase III studies. In 2000, NIH
issued further guidance for Phase I and Phase II studies, including who is responsible for safety monitoring.2 In addition, the guidelines also stated that at a minimum, DSMPs should include a description of how adverse events will
be reported to the Institutional Review Board, FDA, and NIH.
The FDA regulations require that each clinical investigator is responsible for ensuring that a study is conducted according
to the signed investigator statement, the investigational plan, and applicable regulations.3,4 The FDA also recommends that written procedures for monitoring clinical investigations be established to assure the quality
of the study and that each member involved in the monitoring process carries out his/her duties.10 Furthermore, it recommends standardized general procedures that are supplemented by more specific monitoring procedures
tailored to the individual study.10
