A data and safety monitoring plan (DSM plan) is a description of how the investigator will monitor research data and respond to adverse events and unanticipated problems occurring during the course of the research to ensure the safety of participants and the validity and integrity of data collection.
Monitoring of research is important because preliminary data may signal the need to change the research design, change the information presented to participants, or even to terminate the project before the scheduled end date. If the data are not properly analyzed, the research itself may not be valid and the conclusions compromised.
Human subjects protocols that involve more than minimal risk to participants require a DSM plan. In research that involves no more than minimal risk, a DSM plan is generally not required. If a protocol is submitted without a DSM plan, and the IRB determines that the protocol presents more than minimal risk to participants, the investigator may be asked to provide a DSM plan. Some research sponsors require data and safety monitoring plans.
UW-Madison Health Sciences IRBs Office require data and safety monitoring plans (DSM plans) for all protocols involving more than minimal risk.
In addition, a DSM plan is required for all research conducted or supported through the UW-Madison School of Medicine and Public Health’s Comprehensive Cancer Center (UWCCC). The DSM plan must include a mechanism for reporting adverse events and unanticipated problems to the IRB and, when required, to the Veterans Administration Research and Development committee, other University officials and federal agencies.
All research conducted or supported through the Clinical and Translational Research Core (CTRC) of the University of Wisconsin-Madison Institute for Clinical and Translational Research (UW-ICTR) requires a CTRC Data and Safety Monitoring Plan (DSMP). In general, protocols that are deemed high risk by the Research Subject Advocate must also have a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC). PIs working with an outside DSMB or DMC (such as the Cancer Center DMC or Study Sponsor DSMB) need only ensure that the Advocate receives all reports to and from the DSMB to maintain CTRC documentation. For low-risk studies, without an outside DSMB, the CTRC will provide supervision through the RSA and the CTRC Data and Safety Monitoring Committee (DSMC).
When appropriate, the investigator should submit a DSM plan as part of his or her protocol application. The plan should describe how the investigator will monitor research data as it is collected and respond to changes that potentially affect the risk/benefit ratio of the study as well as adverse events and unanticipated problems occurring during the course of the research.
A DSM plan may vary depending on the potential risks, complexity and nature of the study. The level of monitoring in the research plan should be related to the degree of risk posed by the research.
For health sciences protocols, key elements to be incorporated in a DSM Plan are:
• an assessment of risk level and type of monitoring level to be employed; this should include an assessment of the procedures in place to ensure the safety of participants, expected duration of the study, data management system in place to ensure participants’ eligibility for the study and completeness of data (e.g., eligibility checklists, data collection forms)
• a statement of who is responsible for data and safety monitoring and how often it will occur
• procedures for analysis and interpretation of data to ensure sound study design
• a checklist for identification and reporting of adverse events and unanticipated problems that includes:
– a description of what constitutes expected versus unexpected adverse events and how an adverse event will be graded or categorized in terms of seriousness, expectation, and relationship to the study intervention
– a description of what constitutes an unanticipated problem
– how adverse events and unanticipated problems will be reported and the time frame of reporting
• the impact that termination of participants from the study and study closure would have on participants
• a description of the data and safety monitoring committee or board, if one is formed, including the number of members, their roles, and expertise
• actions the responsible party will take concerning specific events or end points
Before approving a research protocol, UW-Madison IRBs will determine whether data and safety monitoring is necessary and, if so, whether the research protocol makes adequate provision for monitoring the data collected to ensure the safety of participants and validity and integrity of data collection. DSM plans can vary widely and still be acceptable to the IRB.
Both the timing and adequacy of the plan for analysis are important. If the data are not analyzed until the project is terminated, the chance to make mid-course corrections is lost. If the data are not properly analyzed, the research itself may not be valid, and proper conclusions may not result.
Data and safety monitoring of research conducted under the jurisdiction of the UW-Madison may be appropriately performed by the investigator, the sponsor (e.g., medical monitor or monitoring committee) or an independent Data and Safety Monitoring Board (DSMB) or Committee.
If research intervention is ongoing over a period of time, DSM plans should generally call for a regular review of accrued research data and other relevant information to ensure the validity and integrity of the data and that there is no change to the anticipated risk/benefit ratio of the research study. There should also be an ongoing review of study procedures so as to ensure that the privacy of research participants and the confidentiality of their research data have not been violated.
http://www.nci.nih.gov/clinical_trials/doc.aspx?viewid=a7fbcf28-458e-4f1b-a8e4-5d9c4a9171d5 (NCI)
http://grants.nih.gov/grants/guide/notice-files/not98-084.html (NIH)
http://www.nimh.nih.gov/researchfunding/safetymonitoring.cfm (NIMH)
http://www.nhlbi.nih.gov/funding/policies/dsm-12.htm (NHLBI)
http://www.niaid.nih.gov/ncn/clinical/decisiontrees/datasafety.htm (NIAID)