As currently mandated by the NIH, EVERY protocol evaluated by the CRC Advisory Committee MUST have a Data and Safety Monitoring Plan (DSMP). To assist the Committee in completing their evaluations of this NIH-mandated requirement, please include all of the required elements. These efforts are to ensure the safety of subjects involved in clinical research conducted through the CRC.

There are two issues regarding safety

1. appropriate collection, recording, and review of data,
2. recognition and recording of adverse events and general safety review as described in sections A and B below

A) Data Collection and Data Monitoring

The protocol must detail how data collection will occur and how quality will be assured, a description of the records to be maintained, and how the study is to be monitored for adherence to the protocol. The protocol should indicate how informed consent will be obtained and by whom. If the study is industry sponsored, please indicate the monitoring agency and how often monitoring will be done. If the study is investigator-initiated, then it is likely that the PI will be responsible for organizing, tracking and evaluating the data. This fact and the frequency of the monitoring should be specified. If there is a Data and Safety Monitoring Board (DSMB) or Safety Monitoring Committee (SMC), there should be a description of the general composition of the board (member names or specialties represented), its duties, and the DSMB charter if available. All studies should detail what data will be reviewed and the procedures for implementing changes as a result of the review (i.e. how deficiencies are to be resolved). The details of what will be assessed for an interim analysis should be included if this is to be done.

B) Safety Monitoring/Adverse Event Reporting

The DSMP must include an assessment of risk and the justification for the risk level (see list below). The level of risk will determine who is responsible for safety monitoring (see below). There should also be a plan for safety review which includes when serious adverse events (SAEs) and non-serious adverse events (AEs) are reported and to whom (i.e. RSRB, DSMB, and CRC), and an AE grading and attribution scale.

(1) PI monitoring only: PI monitors study, with prompt reporting of adverse events and other study related safety information to the RSRB, CRC, sponsor, or other agencies, as needed. Protocol deviations and protocol amendments also need to be reported.

Ex: This level of monitoring would be appropriate for studies with minimal to low risk that can be effectively monitored by the PI.

(2) PI monitoring and safety monitor: PI monitors study as noted above, with oversight by a safety monitor. This individual should have appropriate clinical and research expertise and should have no conflicts in monitoring the study.

Ex: This level of monitoring would be appropriate for moderate to high risk studies that may require independent safety monitoring, such as a relatively small investigator-initiated study involving a vulnerable population.

(3) PI monitoring and DSMB: PI monitors study as noted above, with oversight by a Data and Safety Monitoring Board. DSMB members typically include scientists, clinicians, statisticians, and others who periodically review the safety and integrity of a study and evaluate accumulating data to consider a need for early stopping due to significant evidence of benefit, harm, or futility. DSMB members should have appropriate clinical and research expertise and should have no conflicts in monitoring the study. The description of the DSMB should include the composition of the DSMB (the names of the DSMB chair and its members- if known), how frequently it will meet, and its responsibilities.

Ex: This level of monitoring would be appropriate for studies which: (1) are multicenter; (2) use high risk interventions; (3) trials testing an agent for which little or no toxicity data in humans is available; (4) are blinded to the investigator; or (5) include vulnerable populations (e.g., children, pregnant women, psychiatric patients, prisoners, etc.). All NIH-funded multicenter Phase III clinical trials must have a DSMB.

Please submit copies of adverse event reports to the CRC as they are submitted to the RSRB/WIRB (i.e. send SAE reports as detailed in the protocol, and if applicable, send a copy of the RSRB progress report which lists all other AEs, upon re-approval of the study). Please also send copies of any DSMB or safety committee reports to the CRC as well.

Please contact Nancy Needler 275-1020, if you have any questions regarding the DSMP requirements or would like assistance in writing a plan.

Examples for Risk Assessment

Download these instructions (the information is the same as that in the CRC application):

 CRC DSMP Requirements (MS Word Document)

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