The Data and Safety Monitoring Plan (DSMP)

A Data and Safety Monitoring Plan (DSMP) is a prospectively defined strategy to assess the assumptions made in the trial design while the study is in progress. A properly designed DSM Plan improves the scientific quality and yield from a clinical trial and the protection of human subjects.

The Data and Safety Monitoring Plan (DSMP) needs to address the nature of the safety monitoring and who will be conducting that monitoring. It may be reasonable for a single individual to perform the monitoring in a small trial with minimal/low risk while a local independent or an external data and safety monitoring board (DSMB) may be required for more complex/high risk trials.

Key elements to be incorporated in a Data and Safety Monitoring Plan (DSMP)

• Monitoring level assessment
• Safety contact (we require a contact to be available on call for all protocols for the management of unexpected events including after hours patient safety concerns)
• Description of who will be performing the safety reviews—individual versus contracted research organization (CRO), or a DSMB
• Description and frequency of safety monitoring
• Description of anticipated adverse events
• Adverse event grading
• Plan for reporting adverse events

Overview of the Data Safety and Monitoring Plan

The MetroHealth GCRC has developed policies and procedures to ensure the safety of all research participants and the validity and integrity of the research data. Current General Clinical Research Center (GCRC) policies require a data and safety monitoring plan (DSMP) be developed for all studies conducted on the GCRC.

The GCRC requires investigators to submit a description of the DSMP as part of the protocol review process. It is the GCRC policy not to activate any research protocol without an approved DSMP. Although research study investigators are responsible for the development of the respective DSMP, the Research Subjects Advocate (RSA) at each of the two institutions is the primary resource to help them develop the plan. Investigators are encouraged to discuss their proposed DSMP with the RSA prior to formal submission of the protocol to the GCRC. The DSMP for each study is reviewed by the RSA, the protocol review committee and subsequently approved by the GCRC Advisory Committee (GAC). A Research Subjects Advocate is available at each of its two campuses (University Hospitals of Cleveland and MetroHealth Medical Center ) of the GCRC.

The methods, extent and complexity of the DSMP depend on the nature of the research protocol, the study population and potential risks to participants. In simple observational or low-risk studies, the plan is often very simple requiring monitoring and reporting expected and unexpected adverse events to the GCRC and IRB and other funding agencies. Such a plan is easy to formulate especially using the available template. In contrast, complex, multi-center, blinded studies and others involving vulnerable populations require not only a high level of monitoring but might also need an independent data and safety monitoring board (DSMB).
 

What is included in the Data and Safety Monitoring Plan (DSMP)

Each DSMP must indicate how monitoring will be done, what exactly will be done, when, how often and by whom. In general, the higher the risk, the more frequent and intensive the monitoring will need to be. The GCRC has established three categories of risk: minimal/low risk, moderate risk, and high risk. The GCRC has provided investigators an easy-to-use template to facilitate risk assignments and completion of the DSMP document. Click here if you wish to see a copy of the DSMP Template.
 

Role of GCRC Research Subject Advocate (RSA) in Data and Safety Monitoring Plan (DSMP) Implementation

The RSA is responsible for assuring the GCRC that the DSMP approved for each clinical protocol is fully implemented. The RSA will supervise the review of existing protocols for adequacy of the DSMP and coordinate the implementation of any corrective measures. The RSA in no way replaces or minimizes the primary roles held by the IRB and the principal investigator for the protection of human subjects, or the PI's primary responsibility for detecting, documenting, and reporting adverse events.

All serious adverse events (SAE’s) and study-related unanticipated adverse events at the GCRC need to be promptly reported to the RSA who will notify the GCRC Advisory Committee. The RSA will review these SAE’s expeditiously to assure that it is safe to continue the protocol on the GCRC and/or to determine whether additional safety monitoring or adjustment of the protocol may be required. The RSA will help ensure that GCRC investigators send adverse event reports in a timely manner to the IRB, appropriate Federal agencies, and/or sponsors.

For questions or assistance, please contact the GCRC Research Subject Advocate:

At MetroHealth Medical Center, contact Judy Whitwell, RN, MSN at jwhitwell@metrohealth.org or 216-778-5423.
At University Hospitals Health System, contact Baha Arafah, M.D. at bxa@case.edu or 216-844-4902.