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Monitoring Patient Safety in Clinical Trials:

Establishment and Operation of clinical trial Data Monitoring Committees and Data Safety Monitoring Boards – Helpful links to the FDA and EMA Guidance Documents.

Establishment and Operation of Clinical Trial Data Committees Monitoring

FDA Guidance for Industry
ABSTRACT:] "This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) [...]"

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Guideline on Data Monitoring Committees

EMA Committee for Medicinal products for human use (CHMP)
ABSTRACT: This Guideline document deals with independent Data Monitoring Committees. It is intended as an overview guide to highlight the key issues involved when sponsors include data monitoring committees as [...].

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dsmb handbook

DSMBs-DMCs
Complete Handbook

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Data Monitoring Committees (DMC) and Data Safety Monitoring Boards (DSMB) Definitions, Procedures and Tools

Terms and definitions related to Data Monitoring Committees and Data Safety Monitoring Boards

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DSMBs GxP Quality and Compliance

Your Guide to Compliance and Oversight for All Data Safety Monitoring Boards Management Processes and Outputs 

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