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Secure and compliant software solution for DSMBs, DMCs & Steering Committees

Collect Board Member CVs, schedule meetings, review agenda, send invites, manage authorizations and signatures, file decisions, send notes and much more with Ethical’s eDSMB® application.

At Ethical GmbH, our motivation is to support SPONSORS, AROs and CROs with cost-effective solutions that simplify their daily work without jeopardizing quality.

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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eDSMB Software

A dedicated software
for managing Data Safety Monitoring Boards

DSMB® is a cloud-based software platform that supports all the operations related to your DSMBs, DMCs or Steering Committees

Download Your DSMB-DMC Complete Handbook

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



eDSMB Dossier

eDSMB®
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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