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Home / Data Safety Monitoring Boards / DSMB Auditor View

DSMB Audit

DSMB PROCESS,
PROCEDURES AND PROCEEDINGS
–AN AUDITOR’S VIEW


by Beat Widler, Head Quality Assurance, Ethical GmbH
25+ years with Roche in regulatory affairs, clinical research,
quality assurance and risk management

Download Your DSMB - An Auditor's View

We are EU-GDPR compliant: Your Data will never be used improperly



eDSMB Dossier

eDSMB®
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The DSMB Auditing: Why, When and What to look for?

The following checklist of 10 verification points will help secure adequate QA oversight of the DSMB process. [...]

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Overcoming DSMB Members’ Constraints: The Role of Electronic Platforms

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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Manageability and communication in DSMB

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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