ENSURING DSMB
INTEGRITY:
A GUIDE FOR
CLINICAL TRIAL
PROFESSIONALS
ENSURING DSMB
INTEGRITY:
A GUIDE FOR
CLINICAL TRIAL
PROFESSIONALS
A living document defining roles, responsibilities, governance rules, and decision-making processes. Its adequacy and timely approval are essential.
Auditors assess DSMB member qualifications, financial disclosures, and safeguards against sponsor influence.
Proper handling of patient data, images, and ECGs in line with GDPR and equivalent laws.
Complete records of agendas, votes, minutes, and sponsor feedback must be maintained for inspection readiness.
Ensuring trial teams remain blinded while DSMBs review safety data.
The guide also covers practical aspects such as how to verify computerized systems supporting DSMB operations (e.g., eDSMB®), validate processes, and ensure secure long-term record retention.
The recommended timing for an internal DSMB audit is when 30–40% of patients are randomized and at least two to three DSMB meetings have taken place. This ensures enough data exists to evaluate processes, while still leaving room for corrective actions. The guide also outlines how to prepare Audit Plans, coordinate with DSMB leadership, and identify “Critical to Quality Factors” to focus on during the review.
Whether you’re a sponsor, auditor, DSMB member, or QA professional, this guide equips you with the tools to:
Auditing DSMBs is not a box-ticking exercise — It’s a cornerstone of ethical, high-quality clinical research. This guide, authored by Dr. Beat Widler, Head of Quality Assurance at Ethical GmbH, distills 25+ years of global experience into a practical roadmap for DSMB oversight.
The following checklist of 10 verification points will help secure adequate QA oversight of the DSMB process. [...]
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Data and Safety Monitoring Boards (DSMBs) in clinical trials play a vital role in ensuring participant safety. However, DSMB members navigate significant challenges in the process of making informed decisions.
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Several parties are often involved such as CROs, independent statisticians or freelance medical experts. In this context communication becomes more complex and mistakes can and will be made [...]
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