Researchers agree that the highest standards in clinical research need to be preserved to 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 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
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.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post Safety monitoring oversight adds value to your study appeared first on MassDevice.
from MassDevice http://ift.tt/2waAQUh
Cap comentari:
Publica un comentari a l'entrada