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Enhance Patient Safety with the help of Data Safety Monitoring Boards

Clinical trials frequently extend over a long period of time and patients should be able to participate without being exposed to unavoidable risk. Therefore, the level of risk must be monitored all along the study.

 

To detect possible safety signals, a group of experts external to the study known as Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB) reviews summary clinical data at regular intervals. Based on this review, the committee advises the trial sponsor on potential actions regarding the study.

The Challenge of Managing a Data and Safety Monitoring Board

The first step is to identify the DSMB members and verify their expertise and independence. Once the experts are recruited, the Committee Charter can be finalized, and the kick-off meeting can take place. At each subsequent meeting of the DSMB, blinded and sometimes unblinded data is presented that will allow the experts to detect potential safety signals and decide on the continuation of the study. The sponsor is required to act accordingly and document all actions.

eReconciliation for SAE Reconciliation

Data Monitoring Committees and Data Safety Monitoring Boards Terms Glossary

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

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eReconciliation for SAE Reconciliation

FDA/EMA Guidance about Data Safety Monitoring Boards

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

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Download Ethical eReconciliation for SAE Reconciliation Dossier

The DSMB-DMC Complete Handbook

A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs. 

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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

dsmb definitionsREAD MORE

FDA/EMA Guidance Documents on Data Safety Monitoring Boards

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

dsmb regulationsREAD MORE

9 must-have elements of a DSMB SOP

Here are some instructions on writing the right SOPs for DSMB operations.

dsmb sopREAD MORE