Overseeing clinical studies by a DSMB has become common as sponsors increasingly privilege this method to prevent safety risks and guarantee regulatory compliance. DSMB process compliance is critical for clinical teams and CROs. When correctly designed and configured, electronic platforms for clinical committee management allow to achieve regulatory and charter compliance, confidentiality, and in the end improve performance.
A Data Safety Monitoring Board (DSMB), a.k.a. Data Monitoring Committee (DMC) is a dedicated independent experts committee that periodically reviews aggregated safety and other data from clinical studies to ensure that the safety of participants is safeguarded at all times. Managing DSMBs is the responsibility of the study sponsor and the decision to do it using a software platform versus traditional communication and management tools must be carefully weighed based on objective criteria. We provide below five reasons to privilege software over other solutions.
Reason 1: Traceability
The requirement for auditors to be able to trace all proceedings and decisions is critical for clinical teams and CROs. Using a software platform for managing DSMBs is the only way to ensure a strict traceability of the process since the system automatically generates an audit trail.
Reason 2: Document archival
Ensuring that all relevant documentation is readily archived and can be retrieved for inspections is also a mandatory requirement. Using a software platform is the most efficient way to automate this cumbersome and time-critical step.
Reason 3: Confidentiality
DSMB members have access to highly confidential information. Ensuring that the right data is conveyed to the right individuals, especially for the closed DSMB meetings, can be safely managed by a platform where processes are embedded, and access is restricted based on roles.
Reason 4: Charter compliance
Because the DSMB meets at long intervals with likely changes in the study staff during the time frame, ensuring charter compliance can be difficult. A software platform is configured for consistent, reproducible process and cand send automatic reminders to help users keep track of their planned tasks.
Reason 5: Process management
Managing the DSMB process can be cumbersome especially if a CRO is involved. Whether Sponsor or CRO SOPs are followed, software platform can integrate DSMB rules and ensure consistent workflow thanks to a guided interface.
Considering the above and other elements, it becomes evident that the use of a software platform is the most efficient, comprehensive and compliant approach to managing DSMBs. Ethical’s eDSMB® user-friendly software solution is finely designed to guide users to perform their part of the process step by step, sending timely reminders to keep up the pace and, in the end, save clinicians time, improve process compliance and accelerate timelines. CROs who manage multiple studies and DSMBs can also benefit from the software templates for following their DSMBs SOPs. Please contact us on info@ethical.ch for more information.
