Data Safety Monitoring Boards/Data Monitoring Committees Management Complete Handbook

How-to Guide: Governing and Maintaining Standards for Collecting Clinical Data

DSMBs, DMCs and Steering Committees have existed for a number of years. Regulatory guidance from both major agencies, the FDA and the EMA were issued to advise sponsors and investigators on the good use of such committees.

Abundant information can be found about when, why and how to set up and use DSMBs but we feel that there was still a need for regrouping all that information into this single integrated handbook.

Ethical is a Swiss eClinical company with 16 years of expertise in providing cost-effective, compliant software and customized support for clinical committee management: Clinical and Endpoint Adjudication (eAdjudication®), Protocol Deviations (eDeviation®) , Data and Safety Monitoring Boards and Data Monitoring Committees (eDSMB®), SAE Data Reconciliation (eReconciliation®). Find out more at www.ethicalclinical.com.