Overview
The Data Monitoring Committee (DMC) is comprised of experienced clinical researchers representing a diversity of backgrounds, skills and knowledge. The DMC helps investigators ensure subject safety, research integrity, and compliance with federal regulations and local policies. The DMC also makes recommendations to the PI that could include actions of continuation, modification, suspension, or termination.
Investigators with the DMC as their committee or board of record are required to use the research electronic data capture application (REDCap) for data management. REDCap will provide the DMC and its biostatistician the ability to efficiently collect the needed data for the DMC report and provide safety oversight of the protocol. Study teams must enter accrual information, various outcome data, reportable events including Adverse Events (AEs) & Serious Adverse Events (SAEs), and patient demographics. If you prefer to not use REDCap, your study team will be required to create the DMC report needed for each meeting. Details about this report can be discussed with the DMC manager.
To use the DMC, there is a one-time $1,500 per study fee, which covers the initial DMC review and all subsequent reviews for the life of the protocol. These fees allow ICTR to maintain the clinical research infrastructure created with the CTSA funding from the NIH. Please remember to budget accordingly. DMC staff are available to assist an investigator to determine which electronic case report forms are required. Note: Standard REDCap fees are still applicable and are not included in the DMC fee.
The DMC should be contacted before a protocol receives IRB approval and subject enrollment has begun. We recommend contacting the DMC prior to submitting your application to the IRB by completing the DMC consult request form.
