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Compliance In Focus
Posted by John Lehmann on Thu, Aug 18, 2016

Adding Value to a Study with Safety Monitoring Oversight

Researchers agree that the highest standards in clinical research need to be preserved toSafety_Monitoring.png maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) and/or a Clinical Events Committee (CEC).

IMARC Research’s newest whitepaper underscores the value of an independent, high-quality safety monitoring team that will be sure to add value to your study.

A safety monitoring group can have many different names, but they each have the same goals – patient safety and data integrity. 

  • Data monitoring committee 
  • Data safety monitoring board 
  • Clinical events committee 
  • Medical monitoring group 
  • And others…

The sponsor will determine if and what type of safety monitoring group will be needed based on study risks. The objectives and procedures may vary depending on the role of the safety monitoring group or depending on the risks involved in the study.

A DSMB will review cumulative safety data, and possibly effectiveness data as well, and make recommendations to the sponsor regarding whether it feels the study should continue, continue with modifications, or be terminated.

The CEC instead reviews individual qualifying adverse events and provides adjudications to the sponsor, often to assess relatedness to the investigational product and/or study procedure.

The overall goal of a safety monitoring group is always the same: additional, independent oversight of a study involving human subjects. A safety monitoring group such as a DSMB or CEC is an investment in safety and data integrity that goes beyond checking a box. Seek qualities in an independent, high-quality safety management team that will be sure to add value to the study.

Please take time to download our newest whitepaper and let us know your thoughts.

Data Safety Monitoring Boards and Clinical Events Committees

 

 

Topics: DSMB, Safety Monitoring

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