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DSMP GUIDELINESGCRC Data and Safety Monitoring Plan
Every GCRC protocol must have a data and safety monitoring plan. The need for a DSMP extends to multicenter and pharmaceutical sponsored projects that have an external Data and Safety Monitoring Board (DSMB). GAC review will not be conducted without the inclusion of necessary elements of the protocol, including a statistical section and a Data and Safety Monitoring Plan (DSMP). The plan should be tailored to the complexity and risk of the protocol. If the protocol involves therapeutic intervention or compares two groups with regard to the outcome of a therapeutic intervention, the DSMP must also include monitoring that is external to the investigator.
Elements of a DSMP.
A DSMP must include each of the following elements:
- Risk assessment. The data and safety monitoring plan should include the adverse event grading (serious or non-serious) and attribution (probably related, possibly related, remotely related, unrelated) scales. Classification of events may follow and refer to the HRAC guidelines. This section may refer to the Human Studies section for details of the study risks, but should assess whether this study is minimal risk or greater than minimal risk; if sufficient data are not available, risk may be considered uncertain. Experience with the drug or protocol should be cited in defending the risk assessment. In most cases this can be brief; specific risks are addressed under the Human Studies section of the protocol. If applicable, particularly if the study falls into the greater than minimal risk or uncertain risk categories, an explicit plan for dealing with safety issues that could lead to study interruption and/or termination should be included.
- Monitoring plan. This section should address the following questions. Who will monitor the study (PI and coordinators only; PI and Nurse Manager; PI, Nurse Manager, and RSA; GCRC DSMB; other DSMB). How often will the study be monitored (e.g., before a dose escalation, after a certain number of treated subject, after a certain time period)? For studies of minimal risk, the plan may be for the investigator to review safety data quarterly. For greater than minimal risk protocols, a committee is probably desirable to review the data.
What specific elements will be monitored? Who will be informed of the results of monitoring, and within what time frame? How will results from abnormal laboratory or standard diagnostic tests be handled? Will the subject be notified, and, if so, how and within what time frame? If an entity other than the investigator is monitoring the study, the specific information to be reported should be included here. Briefly justify the data to be monitored and the frequency with which it will be monitored.
- Interim study analysis. This section will apply primarily to clinical trials, particularly those in which clinical implications or safety dictate that the trial should be stopped early if significant positive or negative findings emerge. Will the data be analyzed by the investigators or an external body at any point before the conclusion of the study? Will this interim analysis be used to stop the study? Who will make that decision, and using what criteria? Is there any justification for monitoring significance during the course of this trial?
- Reporting plans. This section must include a statement on how the HRAC, the RSA, and the GCRC administration will be informed of adverse events and safety concerns, particularly for studies that are monitored by an external board. The plan should include annual reporting of adverse events to the IRB, GCRC, and other required agencies or departments. Any other entities that will receive adverse event reports should be specified in the DSMP. This section must also address plans to inform the GCRC Administration and the RSA if for any reason the IRB or any other body temporarily or permanently suspends the study, and should address the time frame within which this will be done. Supplemental Guidelines
- Data accuracy and protocol compliance. How will adherence to the protocol be assured? How will data be handled? How will it be stored, who will have access to it, how will security be addressed? Confidentiality issues should be addressed here or the relevant section of the Human Studies should be referenced.
- Conflict of interest. Any possible conflicts of interest between the study personnel, particularly the PI, just be addressed in the plan. If these conflicts affect the ability of the PI to objectively monitor the progress and safely of the study, the plan should include some external monitor (RSA, Nurse Manager, or other physician).
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